f/EPA
United Statw
Environment*! Protection
Agmcy
Officaof
PatticidM and Toxic SubcUncM
Washington DC 20460
December 1987
PttticidM
Guidance for the
Reregistration of
Pesticide Products
Containing Asulam
as the Active Ingredient
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OMB Control No. 2070-0059
Expires 11/89
GUIDANCE FOR THE
REGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
ASULAM
OR
SODIUM SALT OF ASULAM
AS THE ACTIVE INGREDIENT
OPP NO. 106901, 106902
CAS NO. 3337-71-1, 2302-17-2
CASE NO. 0265
DECEMBER, 1987
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
I. Introduction 1
II. Chemical(s) Covered by this Standard 4
A. Description of Chemiocal
B. Use Profile
III. Agency Assessment 5
A. Summary
B. Toxicology Assessment
C. Other Science Findings
D. Tolerance REassessment
IV. Regulatory Position and Rationale 16
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard 23
VI. Requirements for Submission of Generic Data 25
A. What are generic data?
B. Who must submit generic data?
C. What generic data must be submitted?
D. How to comply with DCI requirements
E. Testing protocols, standards for conducting
acceptable tests, guidance on evaluation and
reporting data
F. Procedures for requesting a change in protocol
G. Procedures for requesting extensions of time
H. PR Notice 86-5 and other requiremetns referenced
or included within this notice
I. Existing stocks provisions upon suspension or
cancellation
VII. Requirement for Submission of Product-Specific Data . 31
VIII. Requirement for Submission of Revised labeling. . . 32
IX. Instructions for Submission 32
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products (sole active)
D. End;use products (multiple active)
E. Intrastate products
F. Addresses
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APPENDICES
I. DATA APPENDICES
Guide to Tables
Table A
Table B
Table C
II. LABELING APPENDICES
Summary of label requirements and table
40 CFR 162.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
III. USE INDEX APPENDIX
IV. BIBLIOGRAPHY APPENDICES
j
Guide to Bibliography
Bibliography
V. FORMS APPENDICES
EPA Form 8580-1 FIFRA §3(c)(2)(B) Summary Sheet
EPA Form 8580-6 Certification of Attempt to Enter Into an
i Agreement with Other Registrants for Development
* of Data
EPA Form 8580-4 Product Specific Data Report
EPA Form 8570-27 Generic Data Exemption Statement
ii
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GLOSSARY OF TERMS AND ABBREVIATIONS
Acceptable Daily Intake,
Dose or RfD.
Also known as the Reference
ADI
a.i. active ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
EEC Estimated Environmental Concentration. The estimated
pesticide concentration in an environment such as a
terrestrial or aquatic ecosystem.
EP End-use Product
EPA U.S. Environmental Protection Agency
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
LC50 Median lethal concentration - a statistically derived
concentration of a substance that can be expected to
cause death in 50% of test animals. It is usually
expressed as the weight of substance per weight or
volume of water or feed, e.g., mg/1 or ppm.
LD50 Median lethal dose - a statistically derived single
dose that can be expected to cause death in 50% of
the test animals, when administered by the route
indicated (oral, dermal, inhalation). It is expressed
as a weight of substance per unit weight of animal,
e.g., mg/kg.
LEL Lowest Effect Level
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system
of recording and tracking studies submitted to the Agency,
MP Manufacturing Use Product
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
iii
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OES Office of Endangered Speciesi, U.S. Fish and Wildlife
Service
PADI Provisional Acceptable Daily Intake
ppm parts per million
RfD Reference Dose
TMRC Theoretical Maximal Residue Contribution
iv
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I. INTRODUCTION
EPA has established the Registration Standards program
in order to provide an orderly mechanism by which pesticide
products containing the same active ingredient can be reviewed
and standards set for compliance with FIFRA. The standards
are applicable to reregistration and future applications for
registration of products containing the same active ingredient.
Each registrant of a product containing an active ingredient
subject to this Standard who wishes to continue to sell or
distribute that product must bring his product and labeling
into compliance with FIFRA, as instructed by this Standard.
The Registration Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA. In its review EPA identifies
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the pesticide.
2. Additional studies necessary to support continued
registration. The additional studies may not have been
required when the product was initially registered or may be
needed to replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product
is not misbranded and that the labeling is adequate to protect
man and the environment.
The. detailed scientific review, which is not contained
in this document', but is available upon request*!, focuses on
the pesticide active ingredient. The scientific review
primarily discusses the Agency's evaluation of and conclusions
from available data in its files pertaining to the pesticide
active ingredient. However, during the review of these data
the Agency is also looking for potential hazards that may be
associated with the end use products that contain the active
ingredient. The Agency will apply the provisions of this
Registration Standard to end use products if necessary to
protect man and the environment.
scientific reviews may be obtained from the Information
Services Section, Program Management and Support Division
(TS--757C), EPA, 401 M St., SW, Washington, D.C. 20460.
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EPA's reassessment results in the development of a
regulatory position!; contained in this Registration Standard1,
on the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory positioni, the Agency may prescribe a variety of
steps to be taken by registrants to maintain their registrations
in compliance with FIFRA. These steps may include:
1. Submission of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
In addition', in cases in which hazards to man or the
environment are identified!, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154
to examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use', the Agency
may propose additional regulatory actions!, such as cancellation
of uses of the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
EPA has authority under the Data Call-in (DCI) provisions
of FIFRA sec. 3(c)(2)(B) to require that registrants submit
data to answer our questions regarding the chemical), toxicological ,
and environmental characteristics and fate of a pesticide.
This Registration Standard lists the data EPA believes are
necessary to resolve our concerns about this pesticide.
These data are listed in the Tables A, Bj, and C in Appendix I.
Failure to comply with the DCI requirements enumerated in
this Registration Standard may result in issuance by EPA of a
Notice of Intent to Suspend the affected product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any time that they
become aware of such information. Registrants should notify
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the Agency of any information, including interim or preliminary
results of studies i, if those results suggest possible adverse
effects on man or the environment. This requirement continues
as long as the products are registered by the^Agency.
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II. CHEMICALS COVERED BY THIS STANDARD
A. Description of the Chemicals
The following chemicals are covered-by this Registration
Standard : —"
Common Names: asulara and sodium salt of asulam
Chemical Name: methyl sulfanilylcarbamate and sodium
salt of methyl sulfanilylcarbamate
Empirical Formula: C8HiQN2°4£> (asulam)
Molecular Weight: 230.2 (asulam)
Chemical Class: Carbamate
Chemical Abstracts Service (CAS) Number: 3337-71-1 (asulam)
2302-17-2 (sodium
salt of asulam)
OPP (Shaughnessy) Number: 106901 (asulam)
106902 (sodium salt of asulam)
Trade Name: Asulox
B. Use Profile
Asulam is a selective postemergent herbicide registered for
the control of certain broadleaf weeds', perennial grasses and
non-flowering plants. The herbicide may be used on sugarcane',
noncrop areas such as rights-of-way!, forestry sites (Christmas
tree plantations i, site preparation!, and conifer release)), ornamentals i,
established turf', and ditchbanks. Asulam's mode of activity
involves interference with the process of plant cell division
and expansion in the meristematic regions of plants -- the
growing points or areas of rapidly dividing cells at the tip
of a stem i, root or branch. It appears to exhibit maximum
herbicidal activity when applied to actively growing immature
weeds. Asulam was initially registered in 1975 and is available
as a 86.4% active ingredient (a.i.) technical/manufacturing-use
product and an end-use product containing 36.2% (a.i.) soluble
concentrate/liquid of the sodium salt of asulam (equivalent to
3.34 pounds of active ingredient per gallon).
Asulam is used principally on sugarcane I, with this use
representing roughly 90% of total usage. The majority of asulam
applied to sugarcane is in Florida where sugarcane acreage accounts
for 50% of total U. S. acreage. It is also used in the
production of sugarcane in Louisiana and Texas; relatively little
asulam is used on sugarcane grown in Hawaii. The remaining
8 to 9% of total asulam used is applied to noncrop sitesi,
particularly commercially produced turf.
Asulam can be applied by surface spray or aerial
equipment. It may also be applied as a spot treatment.
Application rates vary from 1..67 to 6.68 pounds active ingred-
ient/acre depending upon the use pattern and target weed species.
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.•Ill; AG-ENCY-'ASSESSMENT
A. Summary
Based on a review of existing data submitted to support
registration of asulam, the Agency has reached the following
conclusions. The following is only a summary. A more detailed
discussion is contained in sections B and C of this chapter.
1. Asulam produced oncogenic effects in a rat long-term feeding
study. In the rat, there was a statistically significant increase
in thyroid C-cell carcinomas and combined C-cell adenomas/carcinomas
in males at the low and mid doses and a statistically significant
increase of benign pheochromocytomas of the adrenal medulla
and combined benign/malignant pheochromocytomas in males at
the highest dose tested. In a mouse oncogenicity study, compound-
related statistically significant increase in tumors was not produced;
however, due to deficiencies a repeat study is required. Asulam was
tentatively classified as a Category C oncogen (limited evidence
of carcinogenicity in animals).
2. Available data are insufficient to fully assess the
environmental fate of asulam. However, preliminary data indicate
that asulam may have the potential to contaminate ground water.
Additional data are required before the Agency can fully evaluate
this environmental fate characteristic. In addition, there is
preliminary evidence from rotational crop data that asulam
residues may occur in crops rotated on asulam-treated fields.
3. Avaiable ecological effects data show that asulam is
practically non-toxic to avian species, warmwater fish and
honey bees. There is no evidence that asulam poses a threat
to endangered or threatened plant or animal species.
As a result of this review the Agency has identified missing
data necessary to evaluate the environmental and human health
risks associated with the use of asulam. These data must be
developed in order to maintain registrations of products or
register new products containing asulam. A summary of these data
gaps appears in Table 1. Please note that this is only a summary;
complete details can be obtained by referring to the tables in
Appendix I.
The Agency has also determined that, based on existing data,
no unique label statements, other than rotational crop restrictions,
are necessary.
The Regulatory Position and Rationale section discusses the
Agency's position regarding the regulation of asulam.
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TABLE 1
SUMMARY OF DATA GAPS FOR ASULAM
(Refer to Appendix I, Data Tables, for
detailed information and due dates)
Product Ch-emistry — All
Residue Chemistry — Animal Metabolism
Residue Analytical Methods
. , Magnitude of Residues
Environmental Fate — Hydrolysis
Photodegradation (water, soil)
Aerobic and Anaerobic Soil Metabolism
Aerobic and Anaerobic Aquatic Metabolism
Leaching and Adsorption/Desorption
Small-scale Prospective Field Leaching Study
'Field Dissipation (aquatic sediment and forestry)
Rotational Crops (confined and field)
irrigated Crops
Toxicology — Acute Toxicity
Subchronic Toxicity (21-day dermal)
Chronic Toxicity (non-rodent)
Oncogenicity (mouse)
Mutagenicity (Ames test and chromosomal aberration)
General Metabolism
Ecological Effects — Freshwater Fish LC$Q (coldwater fish)
Acute LCso Estuarine and Marine
Organisms (oyster study)
Acute LC Freshwater Invertebrates
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B. Toxicoloqical Assessment
In its toxi.cological evaluation of asulam, the Agency
considered tire'' following data.
Rat Chronic Feedinq/Oncoqenicity
In this study, Sprague Dawley CR-CD rats (50 per dosage group)
were fed doses of 0, 1000, 5000, or 25000 ppm asulam in the
diet for two years. Results show that asulam caused a carcinogenic
effect in the endocrine system of male rats. There was an
increased incidence of thyroid C-cell carcinomas and combined
C-cell adenomas/carcinomas in low- and mid-dose males which
was statistically significant, even though no dose response for
this effect was noted and the incidence decreased at the high
dose. The data also show that asulam caused an increased
incidence of benign adrenal medullary pheochromocytomas and
combined benign/malignant pheochromocytomas in male rats
at the high dose. Supporting evidence includes increased
adrenal medullary hyperplasia in the mid- and high-dose groups.
Non-rieoplastic histopathology also included increased thyroid
follicular hyperplasia in the high dose males. These data are
summarized in Table 2.
The elevated incidences of thyroid C-cell carcinomas at
low and mid. doses and. benign adrenal pheochromocytomas at high
dose exceeded historical control range values for the tumor
types in male Sprague Dawley CR-CD rats.
Systemic effects observed in this study include decreased
body weight gain with a no-observed-effect-level (NOEL) of
1000 ppm from weeks 0 to 52.
Mouse Oncoqenicity
In this study, 60 per dose/sex Carworth CF-1 albino mice
were fed 0, 1500, or 5000 ppm asulam in the diet for 78 weeks.
Results showed a statistically significant positive dose-
related trend for undifferentiated sarcoma of the skin and
subcutis in male mice by analysis with Cochran-Armitage Trend
Test. However, the increased incidence of these tumors at
5000 ppm was not statistically significantly different from
concurrent control level by the Fisher-Exact Test. These data
are summarized in Table 3.
These tumors were not considered compound-related because
1) they occurred only at the high dose in a low incidence, 2)
the incidence was not statistically significant and 3) a
parasitic skin infection was present which could have been related
to the occurrence of skin tumors.
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-A-'repeat mouse oncogenicity study is required due to
the following deficiencies. (1) the use of only two dose
levels rather than the three required by EPA; (2) evidence that
the test animals were in poor health as demonstrated by chronic
kidney inflammation in males and females and parasitic infection
of the skin i, colony and small Intestines of males; (3) the
maximum tolerated dose (MTD) was not achieved.
Several chemicals that are structurally related to asulam
produce thyroid tumors in rodents. These include the herbicide
oryzalin (a Category C oncogen) and the sulfonamide drug
Sulf amethoxazole . Sulphisoxazole I, another sulfonamide was
negative for oncogenicity in rats and mice. The induction of
thyroid tumors by oryzalin and sulfamethoxazole was considered
to be due to indirect anti-thyroid effects.
The Agency has conducted a weight-of-the evidence evaluation
of the oncogenic potential of asulam. According to EPA Guidelines
for Carcinogenic Risk Assessment (September 241, 1986, 51 FR 33992)',
asulam was tentatively classified as a Category C oncogen (limited
evidence of carclnogenicity in animals). Tumors were produced in
only one strain and sex of rodent; and in only a single experiment.
Neither of the tumor responses occurred in a strictly dose-
related fashion. Both of the tumors were of a relatively
common type and there was no apparent decrease in latency.
In addition short term tests for mutagenicity were negative.
This categoriaztion will be reevaluated upon receipt of the
repeat mouse study. Because of this rather limited evidence i,
quantification of human risk was considered inappropriate.
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TABLE 2
(Summary of Tumor Incidence in the Rat
Chronic Feeding/Oncogenicity.Study)
Tumor Type
Dose(ppm)
0 1000
Males
5000
25000
Thyroid
C-Cell Adenoma
C-Cell Carcinoma
Combined
0/43(0%)
0/34(0%)
0/43(0%)
4/43(9%) 2/43(5%) 0/40(0%)
5/38(13%)* 5/31(16%)a 2/33(6%)
9/43(21%)b 7/43(16%)fc 2/40(5%)
Adrenal Pheochromocytoma
Benignc
Malignant
Combined0
3/44(7%)
0/30(0%)
3/44(7%)
4/44(9%)
1/36(3%)
5/44(11%)
4/45(9%)
0/26(0%)
4/45(9%)
10/43(23%)a
0/32(0%)
10/43(23%)a
a= p < 0.05s, b= p < 0.01, Fisher(,s Exact Test; c= Statistically
significant positive dose-related trend (p<0.05); Cochran -
Armltage Trend Test
TABLE 3
(Skin Tumors in Mouse Oncogenicity Study)
Tumor
Type
Dose Level (ppm)
1500 5000
Undifferentiated
Sarcoma of Skin
and Subcutisc
0/41(0%) 0/49(0%)
4/46(8.7%)
c= Statistically significant positive dose-related trend (p<0.05);
Cochran - Armitage Trend Test
Note: The incidences depicted in the tables above refer to the number
of tumor bearing animals (numerator)/number examined
(denominator).
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Subchronic Toxicity
Only supplementary information is available to assess the
subchronic effects of exposure to asulam. However, a six-
month dog study may be upgraded to fulfill both nonrodent sub-
chronic and chronic testing. In this study, six beagle dogs/
sex/dose level were fed 0, 60, 300, and 1500 mg/kg/day asulam in
the diet. Low-dose females were found to have increased thyroid
weights, which were also found in both males and females at the
high dose. Relative thyroid/body weight ratio was increased at
1500 mg/kg/day in males and females, and mean bodyweight gain
at 1500 mg/kg/day was lower in males and females when compared
to controls. The tentative NOEL is therefore 60 mg/kg/day. As
indicated above, this study may be upgraded upon receipt of
appropriate clinical measurement summary tables and other data
described in the Data Tables.
Teratoqenic and Reproductive Effects
Teratology studies conducted in the rat and the rabbit show
no evidence that asulam causes developmental effects. In a
study with rabbits, the animals were administered asulam at levels of
0, 150, 300, and 750 mg/kg/day. The NOEL's for maternal toxicity and
developmental toxicity (fetotoxicity) were 750 mg/kg/day, the
highest dose tested. In a rat teratology study, the animals
were administered 0, 50, 1000, and 1500 mg/kg/day. The NOEL's
for both maternal toxicity and developmental toxicity were
1500 mg/kg/day, the highest dose tested.
In a 2-generation reproductive effects study, asulam was
administered to rats at doses of 0, 1000, 5000, and 25000 ppm.
The NOEL for reproductive effects was 1000 ppm based on the
incidence of fewer live births per litter at the 5000 and 25000
ppm dose levels. There was also a slightly lower fertility
index in FI parents (second generation) at 5000 and 25000
ppm. After statistical analysis of the lower fertility index,
the Agency determined that there was no significant difference
in the average litter size between the controls and the low
dose group (1000 ppm) for the FI females when tested by the
one sided t-test. The mean litter size of the control group,
11.33, was not significantly different from the 1000 ppm
10
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mean,, 10.32 (p=.218 [one sided t value]). There were 18 litters
in the control group and 19 litters in the dose group. The
test for equality of variances was not significant (p=.12).
Asulam therefore has not been shown to impair reproductive
ability. A systemic NOEL was not observed due to relative
female liver weight which was significantly lower than controls
in low, mid and high doses.
Mutaqenic Studies
Three mutagenicity studies were reviewed for asulam —
an Ames test, a cell transformation assay to assess primary
DNA damage, and a chromosomal aberration assay. Only the
cell transformation assay was acceptable and was negative
for mutagenic effects. Additional data are required to
fully assess the mutagenic potential of asulam. if individual
animal data can be provided, a dominant lethal study may be
upgraded to satisfy the chromosome aberration requirement.
Metabolism
No acceptable data are available to evaluate the metabolism
of asulam. The only data available were an elimination
study (invalid) and an absorption, excretion, and metabolism
study (supplementary). The latter showed that asulam is not
completely eliminated in a repeated dose regimen after more than
3 days of administration to rats.' There was some evidence of
accumulation in blood and fat. However, since only 3 rats were
used in this study, the data provided are only of limited value.
A metabolism study is therefore required.
Acute Toxicity
The acute toxicity properties of asulam are not
completely known. There are no data available to assess the
acute oral, dermal and inhalation toxicity of asulam. Primary
eye and dermal irritation studies show that asulam is of low
toxicity (Toxicity Categories III and IV, respectively). A
dermal sensitization study showed that asulam is not a
sensitizing agent. Additional data are required.
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C. OTHER SCIENCE FINDINGS
Environmental Fate
Data to assess adequately the environmental fate
of asulam are unavailable. Data are required as specified
in Table A.
Several environmental fate studies were reviewed. Except
for a leaching and adsorption/desorption study which was partially
acceptable, studies were not adequate when measured against
current testing guidelines. Though asulam has not been found
in ground water, partially acceptable data show that the chemical
is mobile to very mobile in sand, loamy soil, loam and clay
loam soil. In soil columns both the parent compound and degradates
leached and were found as 19-88% of the applied material in the
column leachates. Asulam appears to be resistant to natural
sunlight photolysis, and may be resistant to hydrolysis.
Asulam is rapidly degraded in soil under aerobic conditions.
The half-life appears to range from one to several days; most
of the degraded material becomes tightly bound to the soil.
Under anaerobic (flooded) conditions, the amount of bound
residues appears to decrease and the degradation rate decreases.
Results of a field dissipation study appear to indicate that
asulam residues may move past the 0-6 inch sampling depth to
the 12-24 inch sampling depth. Because these data are largely
inconclusive, however, a ground water monitoring study is being
required to track the movement of residues of asulam and its
degradates in soil, soil-pore water, and shallow ground water.
in addition, although crop rotational data do not meet
EPA's current testing standards, available data indicate that
residues may occur in crops grown in areas treated in prior
years with asulam. The potential for asulam residues to carry
over to subsequent crops will be more fully evaluated when the
required rotational crop data are submitted to the Agency.
Ecological Effects
While the ecological effects data on asulam technical
are limited, data exist on formulated products containing
40% or 60% asulam which can be utilized to satisfy several
ecological effects data requirements. The Agency has reached
the following conclusions based on available data.
1. Toxicity to Birds. Data on asulam technical are insufficient.
However, several studies conducted with formulated products
containing 40% or 60% asulam are adequate to use for a hazard
assessment. These data show that asulam is practically non-toxic
to upland game birds and water fowl on an acute and dietary
basis. LDso values were greater than 4000 mg/kg for mallard
12
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ducki, partridge, pheasant and pigeon. LC5Q values were greater
than 75,000 ppm for pheasant and mallard duck. When these
figures are adjusted to account for exposure to 100% asulam the
values were estimated to be 1600 mg/kg and 45,000 ppmi, respectively.
These values are still within the low toxicity range and demonstrate
that asulam is not expected to adversely affect avian wildlife.
2. Toxicity to Aquatic Organisms
Asulam technical is practically non-toxic to warmwater fish
with an LC5Q value of >180 ppm for bluegills. There is a data gap for
toxicity to coldwater fish and such data are being required.
A study on the acute toxicity of technical asulam to
aquatic invertebrates demonstrated that the chemical is slightly
toxic to Daphnia magna with an acute LC5Q of 27 ppm. However I
this study was invalidated by a laboratory audit and thus must be
replaced.
Acute LC5Q studies with estuarine/marine species show that
technical asulam is practically nontoxic to fiddler crabs (>100
ppm) and grass shrimp (>100 ppm). However i, data are also requi
to assess toxicity to oysters.
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3. Toxicity to Bees
An acceptable acute contact study demonstrated that asulam is
relatively nontoxic to honey bees (1.28% mortality at 36.26
micrograms per bee). No additional data are required.
In summary, based on information about the use patterns of
asulami, the estimated environmental concentrations of its residues',
and available toxicity data', the Agency does not expect that the use
of asulam will pose a hazard to endangered terrestrial wildlife
species or aquatic organisms i, but requires additional data to be
certain.
13.
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D. TOLERANCE REASSESSMENT
A tolerance of 0.1 ppm has been established for
residues of asulam in or on sugarcane (40 CFR Part 180.360).
No Mexican tolerance or Codex MRL exists for residued of asulam
in or on sugarcane. Therefore, no compatibility questions exist
with respect to the Codex MRL. A negligible residue tolerance is
in effect in Canada for asulam residues in or on flax. EPA has
evaluated the data supporting the tolerances and has reached
the following conclusions.
Residue Data. The residue data reviewed in support of
this tolerance indicate the following:
1. The metabolism of asulam in sugarcane is adequately
understood. Asulam undergoes a complex degradative pathway
involving hydrolysis of the carbamate ester, hydroxy.lation,
and subsequent transformation into naturally occurring plant
constituents. The major residues are the parent compound
and six of its sulphanilamide-containing metabolites. The
single tolerance for residues in or on sugarcane is currently
expressed in terms of asulam per se.*
2. The metabolism of asulam in animals is not completely
understood. Available data adequately depict metabolism of
asulam only in ruminants (goats). These data show that greater
than 91% of administered [^-^C] asulam was eliminated by two .
goats in urine and feces within 7 days of dosing at 5 mg/kg,
equivalent to roughly 100 ppm in the diet. Residues in tissues
were
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In addition, available processing studies are inadequate because
residues of asulam were not determined in bagasse, molasses,
or refined sugar processed from sugarcane bearing measurable
residues. Data depicting asulam residues on the raw
agricultural commodity sugarcane and processed products are
required.
4. Adequate spectrophotometric methods exist for collection of
data on asulam residues in or on sugarcane and its processed
products and in animal commodities. However, asulam has not
been analyzed by multiresidue methods as required by the
residue chemistry data requirements (40 CFR 158.125). Residues
of asulam in or on sugarcane samples must therefore be
subjected to analysis by multiresidue protocols.
5. Available data are sufficient to determine that residues
of asulam per se are stable in or on frozen plant commodities
for up to 13 months, in milk for 1 week and in animal tissue
for up to 1 month. However, all residue data requested
in this registration standard must be accompanied by data
regarding length and conditions of sample storage.
Acceptable Daily Intake: The toxicological data for asulam are
insufficient to determine an Acceptable Daily Intake (ADI).
However, a Provisional Acceptable Daily Intake (PADI) has been
calculated based on a 2-g"eneration reproductive effects study
with a reproductive NOEL of 50 mg/kg/day (1000 ppm) and using an
uncertainty factor of 1000. Because this study did not establish
a systemic NOEL a 10-fold uncertainty factor was used in addition
to the 100-fold factor used to account for gaps in the data base.
The PADI with a 1000-fold safety factor is calculated to be
0.05 mg/kg/day. A comparison of the published tolerance to
the PADI was conducted using the Tolerance Assessment System
Routine Chronic Analysis. Based on the analysis, a Theoretical
Maximum Residue Contribution (TMRC) for the U.S. population was
calculated to be 0.0001837 mg/kg/day, which utilizes 0.3673 percent
of the PADI. Using the TMRC provides a conservative estimate
since it does not consider the effect of processing on residue
levels in the raw agricultural commodity, that actual residue
levels may be lower than the established tolerance, and that
less than 100 percent of the crop is treated.
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IV. REGULATORY POSITION AND RATIONALE
A. Regulatory Positions and Rationale
Based on the review and evaluation of all available data on
asulam, the Agency has made the following determinations.
Where label revisions are imposed, specific language is set
forth in Section C of this Chapter.
1. The Agency will not begin a special review of asulam at .
this time.
Rationale; Although asulam is oncogenic to rats, it does not
meet the criterion in 40 CFR 154.7(b)(2) for starting a special
review based on this effect. EPA's 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..."
(50 FR 49016, November 27, 1985). EPA concludes at this time
that the risk of oncogenic effects from exposure to asulam is
not of sufficient concern to warrant a special review. Further,
asulam does not meet any other criteria for special review at this
time.
2. The Agency is concerned that asulam has the potential
to leach to ground water and is requiring small-scale field
leaching studies to assess further this environmental fate
characteristic.
Rationale; Laboratory column leaching data indicate that asulam
is mobile to very mobile in sand, loamy soil,"loam and clay
loam soil. Field dissipation studies indicate that asulam may
move to a 12-24 inch sampling depth. In view of these facts
and other known environmental characterises of asulam, the
Agency determined that small-scale leaching studies (in lieu of
further soil dissipation studies) must be conducted to track
the movement of residues of asulam and its degradates in soil,
soil-pore water, and shallow ground water. Since the required
data are intended to further clarify the incomplete data on the
leaching potential of asulam, the Agency is not requiring
interim label advisory statements at this time.
3. The Agency is imposing rotational crop restrictions on asulam.
Rationale; As discussed in Part III,C. of this document,
there is evidence from studies which are scientifically sound
(although not satisfying EPA's current testing guidelines) that
asulam residues accumulated in rotational crops grown in soil
with both 124-day and 248-day treatment-to-planting intervals.
Therefore, a one year crop rotation restriction must appear on
the label. If the results of additional crop rotation data
required by this standard indicate that residues will occur in
crops planted more than one year after asulam application, a
tolerance must be obtained for the rotated crop.
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4. The Agency is reauiring additional data on the metabolism
of asulam in animals and may, upon- review of these data, amend
the tolerance expression (asulam per se) for sugarcane to
include metabolites of toxicological significance.
Rationale:
The metabolism of asulam in animals is not completely
understood. There are sufficient data to depict the animal
metabolism of asulam in ruminants (goats). Data are reguired
to identify and guantify asulam residues in poultry.
The metabolism of asulam has been sufficiently delineated
in sugarcane, where studies have identified six of asulam1s
sulphaniliamide-containing metabolites. Depending upon the
results of the animal metabolism studies and the toxicological
significance of the metabolites, the tolerance expression may
reguire amendment to include both the parent compound and
metabolites.
5. The Agency is reguiring additional data to support the
existing tolerance for residues of asulam on sugarcane.
Rationale; A review of the available data indicates that the
Agency does not have sufficient residue data to support the
established tolerance for asulam on sugarcane.
6. The Agency is reguiring processing studies to determine
residues of asulam in bagasse, molasses, and refined sugar
processed from sugarcane bearing measurable residues.
Rationale: Existing data are insufficient to determine whether
residues of asulam concentrate in these processed products
of sugarcane.
7. The Agency is reguiring that residues of asulam in or
on sugarcane be subjected to analysis by multiresidue protocols,
Rationale; Adeguate spectrophotometric methods exist for
collection of data on asulam residue in or on sugarcane and
its processed products and in animal commodities. However,
asulam residues have not been analyzed by multiresidue methods
as reguired by the residue chemistry data reguirements
set forth in 40 CFR 158.125.
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8. The Agency is requiring that all labels of end-use products
containing asulam registered for use on sugarcane continue
to restrict application to 90 days before harvest and restrict
the grazing of sugarcane and feeding of fodder and forage to
livestock.
Rationale;
While residue chemistry and toxicological data are generated
and evaluated, current label restrictions will limit the possibility
of impermissible-residues in food or feed.
9. The Agency will not require reentry protection data to be
submitted or impose an interim reentry interval for asulam
products at this time.
Rationale;
Asulam does not meet the 40 CFR 158.140 criteria for
submitting reentry data: Although there are data gaps acute
toxicity appears to be low (Toxicity Category III & IV by primary
eye and dermal irritation, and not a sensitizing agent). Little
reentry exposure would be expected from early postemergent use of
asulam on non-crop and sugarcane sites. Current practices in
sugarcane include hand-harvesting, but sugarcane is burned
standing in fields before harvest. Burning will result in
dissipation of the pesticide and removal of pesticide treated
foliage.
10. The Agency will not require a restricted use classification
for asulam end use products.
Rationale;
Asulam is not acutely toxic in avaiable studies, and,
therefore, does not meet the criteria (40 CFR 162.11) for a
restricted use classification.
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11. The Agency will not establish any new food/feed additive
regulations pursuant to section 409 of the Federal Foodi,
Drugi, and Cosmetic Act (FFDCA).
Rationale:
The Delaney Clause in section 409 of the FFDCA bars the
establishment of food additive regulations for substances
which induce cancer in man or test animals', with certain exceptions
which may not apply here. The Agency is currently developing a position
relative to the Delaney Clause and FIFRA. Once this policy
has been established i, the Agency will determine what action is
required in relation to pesticides which have induced positive on-
cogenic responses in chronic animal studies.
12. While the data gaps are being filled!, currently registered
manufacturing-use products (MPs) and end-use products (EPs)
containing asulam as the sole active ingredient may be sold',
distributed!, formulated and used in the United States', subject
to the terms and conditions specified in this Registration
Standard. Registrants must provide or agree to develop
additional datai, as specified in Table A of the appendices', in order
to maintain existing registrations.
The Agency will issue registrations for substantially
similar products. However^ new uses will be approved only
on a case-by-case basis after considering the effect on the
theoretical maximum residue contribution (TMRC)', the maximum
permissible intake (MPI)i, and the oncogenic risks.
Rationale ;
While the currently available data are not adequate to
support the registration of any registered asulam product
unconditionally under FIFRA section 3(c)(5)(, the available
data do support the conditional registration of all of the
currently registered products. Under the FIFRA, the Agency
does not normally cancel or withhold registration merely
because data are missing or inadequate [see FIFRA sections
3(c)(2)(B) and 3(c)(7)]. Issuance of this Standard provides
a mechanism for identifying data needs. These data will be
reviewed and evaluated. The Agency will then determine
whether additional regulatory changes are necessary.
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B. CRITERIA FOR REGISTRATION
To be covered under the Standard, manufacturing-use products
must contain asulam as the sole active ingredient, bear required
labeling, and conform to the product composition, acute toxicity
limits, and use pattern requirements listed in Appendix III,
EPA Index to Pesticide Chemicals.
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To be registered or reregistered under this Standard,
manufacturing-use products must contain asulam as the sole
active ingredient. Each manufacturing-use formulation proposed
for registration must be fully described with an appropriate
certification of limits, stating maximum and minimum amounts
of the active ingredient and inert ingredients which are
present in products, as well as impurities found at greater
than 0.1%.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade
and manufacturing-use products containing asulam, provided that
the product labeling bears appropriate precautionary statements
for the acute toxicity category in which each product is placed,
as required by 40 CFR 162.10.
3. Use Patterns
To be registered under this Standard, technical grade or
manufacturing-use products containing asulam may be labeled for
formulation into end-use products registered for the uses
listed in Appendix III, EPA Index to Pesticide Chemicals —
Asulam. This index lists all registered uses, as well as the
approved maximum application rates and frequencies.
General use patterns included in Appendix III include:
terrestrial food crop ( agricultural crops); terrestrial nonfood
crop (ornamental plants and forest trees, noncrop, wide area,
and general indoor/outdoor treatments); aquatic nonfood (aquatic
sites); and forestry.
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D. LABELING
In order to remain in compliance with FIFRA, manufacturing-
use products and end-use products as covered by this Standard,
must bear appropriate labeling as specified in 40 CFR 162.10.
Appendix II contains information on label requirements.
Pesticide products containing asulam may not be released
for shipment by the registrant after February 1, 1989 unless
the product bears an amended label which complies with the
requirements of this Standard.
Pesticide products containing asulam may not be distributed,
sold,, offered for sale, held for sale, shipped, delivered for
shipment, or received (and having been so received) delivered,
or offered to be delivered by any person after February 1, 1990
unle£»s the product bears an amended label which complies with the
requirements of this Standard.
In addition to the above, in order to remain in compliance
with FIFRA, the following information must appear on the
labeling of manufacturing-use and end-use products as specified
below .
1. Ingredient Statement
MPs must list the active ingredient as:
Asulam: methyl sulfanilylcarbamate. %
EPs must list the active ingredient as:
Sodium salt of asulam (methyl sulfanilylcarbamate)....%
2. Use Pattern Statements
All manufacturing-use products must state that they are
intended for formulation into end-use products for acceptable
use patterns. Labeling must specify sites which are listed
in Use Patterns, Section C.3. However, no use may be included
on the label where the registrant fails to agree to comply with
the data requirements in Table A for that use pattern.
3. Precautionary Statements
Statements for Manufacturing-Use Products
The labels of a technical grade or manufacturing use product
must bear statements reflecting the compound's acute human
toxicity, as specified in 40 CFR 162.10, and statements
pertaining to environmental hazard. In addition, the label
of each manufacturing-use product must contain the following
environmental statement:
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"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 the 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.
The following statements must appear on the label of
each product:
"Do not apply directly to water or wetlands (swamps,
bogs, lagoons, marshes, or potholes). Do not clean
equipment or dispose of equipment washwater in a manner
that will contaminate water resources."
"Do not rotate with any crop which is not registered
for use with Asulam for one year following the last
application of this chemical."
"Do not treat sugarcane within 90 days of harvest. Do
not graze or feed sugarcane forage and fodder to
livestock."
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submission or changes in composition1, labeling or
packaging of the product. The applicable requirements depend
on whether the product is a manufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple, active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use1, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B2
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms1, Confiden-
tial Statement of Formula', data compensation provisions)
associated with reregistration.
2 Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registra-
tion Standard. Table B lists product-specific data applicable
to manufacturing use products. The data in Tables A and B
need not be submitted by a producer who is eligible for the
forroulator' s exemption for that active ingredient.
Table C lists product-specific data applicable to end use
products. The Agency has decided that', in most cases', it
will not require the submission of product-specific data for
end use products at this time. Therefore most Registration
Standards do not contain a Table C.
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B. •• Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:
1. The data requirements listed in Table A.
2. The labeling requirements specified for manufacturing
use products in Section IV.
C. End use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to the
end use product.
2. If eligible for the formulator's exemption3, the
data requirements listed in Table C.
3. If not eligible for the formulator's exemption, the
data requirements listed in Table A and the data require-
ments listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of
multiple active ingredients are subject to:
1. If not eligible for the formulator's exemption,
the date requirements listed in Tables A and C.
3 if you purchase from another producer and use as the
source of your active ingredient only EPA-registered products,
you are eligible for the formulator's exemption for generic
data concerning that active ingredient (Table A) and product-
specific data for the registered manufacturing use product
you purchase (Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient,
or acquire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption
and become subject to the data requirements in Table A.
2) If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end use
producers lose the exemption, and become subject to those
data requirements.
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2. If eligible for the formulator's exemption, the
data requirements listed in Table C.
3. The labeling requirements specified for end use
products in Section IV.
VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice.
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the regis-
tration of products containing this active ingredient.4
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and § 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is complying
with the data request.
If you are granted a generic data exemption, you rely on
the efforts of other persons to provide the Agency with the
required data. If the registrants who have committed to
generate and submit the required data fail to take appropriate
steps to meet the requirements or are no longer in compliance
with this data requirements*notice, the Agency will consider
4 Registrations granted after issuance of this Standard will
be conditioned upon submission or citation of the data listed
in this Registration Standard.
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that both they and you are not in compliance and will normally
initiate proceedings to suspend the registrations of both
your product(s) and their product(s) unless you commit to submit
and submit the required data in the specified timeframe. In
such cases, the Agency generally will not grant a time extension
for submitting the data.
If you are not now eligible for a formulator's exemptioni,
you may qualify for one if you change your source of supply
to a registered source that does not share ownership in
common with your firm. If you choose to change sources of
supply1, the Confidential Statement of Formula must identify
the new source(s) and you must submit a Formulator's Exemption
Statement form.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic
data relevant to the uses of your product ifl, at the time
the application is submitted', the data have been submitted
to the Agency by current registrants. If the required data
have not yet been submitted^ any new registration will be
conditioned upon the new registrant's submission or citation
of the required data not later than the date upon which
current registrants of similar products are required to provide
such data. See FIFRA sec. 3(c)(7)(A). If you thereafter fail
to comply with the condition of that registration to provide
data', the registration may be cancelled (FIFRA sec. 6(e)).
C. What generic data.must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient', the uses for which such data are required',
and the dates by which the data must be submitted to the
Agency.
D. How to comply with PCI requirements.
Within 90 days of your receipt of this Registration
Standard), you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or "more
registrants to jointly develop (or share in the cost of
developing) the data', but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also provide
26
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EPA with documentary evidence that an agreement has been
formed which allows you to rely upon the data to be submitted.
Such evidence.may be: (1) your letter offering to join in
an agreement and the other registrant's acceptance of your
offer', (2) a written statement by the parties that an agreement
exists', or (3) a written statement by the person who will be
submitting the data that you may rely upon its submission.
The Agency will also require adequate assurance that the
person whom you state will provide the data is taking appropriate
steps to secure it. The agreement to produce the data need
not specify all of the terms of the final arrangement between
the parties or a mechanism to resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number from'the Registration Support and Emergency
Response Branch, Registration Division. The request must
include the following information:
a. A list of the members of the consortium;
b. The name and address of the designated representative
of the consortium, with whom EPA will correspond
concerning the data;
c. Identity of the Registration Standard containing
the data requirement;
d. A list of the products affected (from all members
of the consortium); and
e. Identification of the specific data that the con-
sortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submissions by the consortium.
3. You have attempted to enter into an agreement to
jointly develop data1, but no other registrant has accepted
your offer. You request that EPA not suspend your registration
for non-compliance with the PCI. EPA has determined thati,
as a general policy, it will not suspend the registration of
a product when the registrant has in good faith sought and
continues to seek to enter into a data development/cost
sharing program^ but the other registrants developing the
data have refused to accept its offer. [If your offer is
accepted', you may qualify for Option 2 above by entering
into an agreement to supply the data.]
In order to qualify for this method1, you must:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
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registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must',
at a minimum1, contain the following language or its equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement
to be bound by binding arbitration as provided by FIFRA
section 3(c)(2 )(B)(iii).
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offen, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCIi, then you
may qualify for this option. In order for you to avoid
suspension under this method!, you may not later withdraw or
limit your offer to share in the burden of developing the
data.
In addition!, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice in a timely manner. If the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant will normally be subject to initiation of suspension
proceedings i, unless you commit to submit and submit the required
data in the specified timeframe. In such cases', the Agency
generally will not grant a time extension for submitting the data.
4. You request a waiver of the data requirement. If
you believe that a data requirement does not (or should not)
apply to your product or its uses', you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a requirement does not apply.
Since the Agency has carefully considered the composition and
uses of pesticide products in determining that a data require-
ment applies, EPA does not anticipate that many waivers 'will
be granted. A request for waiver does not extend the time-
frames for developing required datal, and if your waiver
request is denied I, your registration may be suspended if you
fail to submit the data.
5. You request that EPA amend your registration by deleting
the uses for which the data are needed. You are not required
to submit data for uses which are no longer on your label.
6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed.
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E. Testing Protocols, Standards for Conducting Acceptable
Tests1, Guidance on Evaluating and Reporting Data.
All studies required under this Noti.ce- must be conducted
in accordance with test standards outlined in the Pesticide
Assessment Guidelines', unless other protocol or standards are
approved for use by the Agency in writing.
As noted hereini, these EPA Guidelines), which are referenced
in the Data Tables', are available from the National Technical
Information Service (NTIS)', Attn: Order Desk', 5285 Port Royal
Road, Springfield, VA 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if
the OECD-recommended test standards conform to those specified
in the Pesticide Data ' Requirements regulation (Part 158.70).
Please note i, however1, that certain OECD standards (such as
test duration), selection of test species!, and .degradate
identification which are environmental fate requirements) are
less restrictive than those in the EPA Assessment Guidelines
listed above. When using the OECD protocols; they should be
be modified as appropriate so that the data generated by the
study will satisfy the requirements of Part 158. Normally,
the Agency will not extend deadlines for complying with data
requirements when the studies were not conducted in accord
with acceptable standards. The OECD protocols are available
from OECD, 1750 Pennsylvania Avenue', N.W., Washington, D.C.
20006.
F. Procedures for requesting a change in testing protocol.
If you will generate the required data and plan to use
test: procedures which deviate from EPA's Pesticide Assessment
Guidelines or the Reports of Expert Groups to the Chemicals
Group i, Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme1, you must submit for EPA
approval the protocols you propose to use.
You should submit your protocols before beginning testing,
because the Agency will not ordinarily accept as sufficient
studies using unapproved protocols. A request for protocol
approval will not extend the timeframe for submission of the
data i, nor will extensions generally be given to conduct
studies due to submittal of inappropriate protocols.
G. Procedures for requesting extensions of time.
If you think that you will need more time to generate
the data than is allowed by EPA's schedule*, you may submit a
request for an extension of time. Any request for a time
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extension which is made as an initial response to a section
3(c)(2)(B) request notice must be submitted in writing to
the Product Manager listed at the end of this section and
must be made by the 90-day deadline for response. Once
dates have been committed to and EPA has accepted these
commitments (, any subsequent requests for a time extension
must be submitted in writing to the Office of Compliance
Monitoring at the address given in Section IX.E.
EPA will view failure to request an extension before
the data submission response deadline as a waiver of any
future claim that there was insufficient time to submit the
data. While EPA considers your request', you must strive to
meet the deadline for submitting the data.
The extension request should state the reasons why you
believe that an extension is necessary and the steps you
have taken to meet the testing deadline. Time extensions
normally will not be granted due to problems with laboratory
capacity or adequacy of fundingi, since the Agency believes
that with proper planning these can be overcome.
A request for an extension does not extend the timeframe
for submission of the data. If EPA denies your request for
a time extension and you do not submit the data as requested,
EPA may begin proceedings to suspend the registrations of
your products.
H. PR Notice 86-5 and Any Other Requirements Referenced or
Included Within this Notice.
All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data!,
including the manner of reporting, the completeness of results!,
and the adequacy of any required supporting (or raw) data',
including), but not limited tof, requirements referenced or
included in this Notice or contained in PR Notice 86-5 (issued
July 29, 1986).
I. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under
FIFRA sec. 3(c)(2)(B)^ an existing stocks provision is not
consistent with the Act. Accordinglyi, the Agency does not
anticipate granting permission to sell or distribute existing
stocks of suspended product except in rare circumstances.
If you believe that your product will be suspended or cancelled
and that an existing stocks provision should be granted!; you
have the burden of clear~ly demonstrating to EPA that granting
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such permission would be consistent with the Act. The following
information must be included in any request for an existing
stocks provision:
1. Explanation of why an existing stocks provision is
necessary', including a statement of the quantity of
existing stocks and your estimate of the time required
for their sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data'are required to maintain your registrations
in effect. Product-specific data are derived from testing
using a specific formulated product', and), unlike generic
data', generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration Standard.
If you have a manufacturing use product', these data are
listed in Table B. If you have an end use product), the data
are listed in Table C. As noted earlier', the Agency has
decided that it will not routinely require product-specific
data for end use products at this time. Thereforel, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data require-
ments', you must follow the same procedures as for generic data.
See Section VI. D, E, F, and G. You should notei, however i, that
product chemistry data are required for every product', and the
only acceptable responses are options VI.D.I. (submit data)
or VI.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.
31
-------
VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELING
FIFRA requires each product to be labeled with accurate!,
complete and sufficient instructions and precautions (, reflecting
the Agency's assessment of the data supporting the product
and its uses. General labeling requirements are set out in
40 CFR 162.10 (see Appendix II - LABELING and SUMMARY). In
addition!, labeling requirements specific to products containing
this pesticide are specified in Section IV.D of this Registra-
tion Standard. Applications submitted in response to this
notice must include draft labeling for Agency review.
If you fail to submit revised labeling as required!,
which complies with 40 CFR 162.10 and the specific instructions
in Section IV.D., EPA may seek to cancel or suspend the
registration of your product under FIFRA sec. 6.
IX. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing Use Products (MUPs) containing the subject
pesticide as sole active ingredient.
1. Within 90 days from receipt of this document', you
must submit to the Product Manager in the Registration Division
for each product subject to this Registration Standard:
a. The "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA
Form 8580-1)1, with appropriate attachments. 5
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27)1,
if applicable.
d. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.80-152.99.
5 If on the Summary Sheet!, you commit to develop the datai,
present arguments that a data requirement is not applicable
or should be waived!, or submit protocols or modified protocols
for Agency review!, you must submit a copy of the Summary
Sheet (and any supporting information) to the Office of
Compliance Monitoring!, which will be monitoring the data
generated in response to this notice. This submission is in
addition to responding to the Product Manager (, and should be
submitted to the Office of Compliance Monitoring at the
address given at the end of this section. (Actual studies
are not to be submitted to the Office of Compliance Monitoring.)
32
-------
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Application for Pesticide Registration (EPA
Form 8570-1) . .
Jx. Two copies of any required product-specific data
(See Table B).
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for
storage in 8-1/2 x 11 files. The draft.label must indicate
the intended colors of the final label, clear indication
of the front panel of the label, and the intended type
sizes of the text.
d. Product Specific Data Report (EPA Form 8580-4).
3. Within the times set forth in Table A, you must
submit to the. Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
B. Manufacturing Use Products containing the subject pesticide
in combination with other active ingredients.
1. within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA sec... 3(c) (2) (B) Summary Sheet/ with appropriate
attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within 9 months of receipt of this document, you must
submit to the Product Manager:
Three copies of draft labeling, including the container
label and any associated supplemental labeling. Labeling
should be either typewritten text on 8-1/2 x 11 inch
paper or a mockup of the labeling suitable for storage
in 8-1/2 x 11 files. The draft label must indicate the
intended colors of the final label, clear indication of
the front panel of the label, and the intended type
sizes of the text.
33
-------
3. Within the time frames set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met,.immediately notify the Product Manager and
_the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
C. End Use Products containing the subject pesticide as sole
active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for
storage in 8-1/2 x 11 files. The draft labeling must
indicate the intended colors of the final label, clear
indication of the front panel of the label, and the
intended type sizes of the text. End use product labeling
must comply specifically with the instructions in Section IV
(Regulatory Position and Rationale).
D. End Use Products containing the subject active ingredient
as one of multiple active ingredients
Within 9 months from the receipt of this document, you
must submit to the Product Manager:
Three copies of draft labeling, including the container
label and any associated supplemental labeling. Labeling
should be either typewritten text on 8-1/2 x il inch
paper or a mockup of the labeling suitable for storage
in 8-1/2 x 11 files. The draft labeling must indicate
the intended colors of the final label, clear indication
34
-------
of the front panel of the label, and the intended type
sizes of the text. End use product labeling must comply
specifically with the instructions in Section IV (Regulatory
Position and Rationale).
E. Intrastate Products containing the subject pesticide either
as sole active ingredient or in combination with other
active ingredients.
These products are being called in for full Federal regis-
tration. Producers of these products are being sent a letter
instructing them how to submit an application for registration.
F. Addresses
The required information must be submitted to the following
address:
Richard F. Mountfort (PM-23)
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
The address for submissions to the Office of Compliance
Monitoring is:
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460.
35
-------
APPENDIX I
DATA TABLES
36
-------
• ' TGUIDE-T '••"
'GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Tab1e C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement' (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment Guidelines,
which are available from the National Technical Information
Service, 5285 Port Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the composition
of the test substance required to be used for the test, as
follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The following
letter designations are used for the given use patterns:
A =» Terrestrial, food
B = Terrestrial, non-food
C = Aquatic, food
D = Aquatic, non-food
E = Greenhouse, food
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
Any other designations will be defined in a footnote to the table.
37
-------
TGUIDE-2
4. Does EPA have data? (Column 4). This column indicates one
of three answers:• . . . .
YES - EPA has data in its files that satisfy this data
requirement. These data may be cited by other registrants
in accordance with data compensation requirements of
Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two required species,
or may possess data on one test substance but not all.
The term may also indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
NO - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional infor-
mation.
5. Bibliographic citation (Column 5). If-the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no
MRID number has been assigned. Refer to the Bibliography
Appendices for a complete citation of the study.
60 Must additional data be submitted? (Column 6). This
column indicates whether the data must be submitted to the
Agency. If column 3 indicates that the Agency already has
data, this column will usually indicate NO. If column 3
indicates that the Agency has only partial data or no data,
this column will usually indicate YES. In some cases, even
though the Agency does not have the data, EPA will not require
its submission because of the unique characteristics of the
chemical; because data on another chemical can be used to
fulfill the data requirement; or because the data requirement
has been waived or reserved. Any such unusual situations
will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column 5 requires
that data be submitted, this column indicates when the data
are to be submitted, based on the issuance date of the Regis-
tration Standard. The timeframes are those established either
as a result of a previous Data Call-in letter, or standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
38
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ASULAM
Test
Data Requirement Substance
§158.120 Product Chemistry
Product Identity:
61-1 - Product Identity and
Disclosure of Ingredients
61-2 - Description of Beginning
Materials and Manufacturing
Process
61-3 - Discussion of Formation of
Impurities
Analysis and Certification of
Product Ingredients:
62-1 - Preliminary Analysis of
Product Samples
62-2 - Certification of Limits
62-3 - Analytical Method
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Use
Pattern
All
All
All
All
All
All
Does EPA
Have Data?J_/
. N/A
N/A
N/A
N/A
N/A
N/A
Bibliographic
Citationl/
N/A
N/A
N/A
N/A
N/A
N/A
Must
Additional
Data Be
Submitted?
Yes2/
Yes^/
Yes4/
Yes_5/
Yes6/
YesT/
Time Frame
for
Submission
6 Months • '
6 Months
6 Months
12 Months
12 Months
12 Months
Physical and Chemical Characteristics :
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density Bulk Density!, or
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
All
All
All
All
All
All
N/A
N/A
N/A
N/A
N/A
TO
«•> 7 N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yes
Yes
Yes
Yes8/
Yes9/
Yes
6 Months
6 Months
6 months
6 Months
6 Months
6 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ASULAM
Data Requirement
Test
Substance
Use
Pattern
Does EPA
Have Data?
Bibliographic
Citation
Must
Additional
Data Be
Submitted?
Time Frame
for
Submission
§158.120 Product Chemistry (Continued):
Physical and Chemical Characteristics
(Continued) :
63-8 - Solubility
63-9 - Vapor Pressure
63-1 0 - Dissociation Constant
63-11 - Octanol/Water Partition
Coefficient
63-12 - pH
63-13 - Stability
TGAI or PAI
TGAI or PAI
TGAI or PAI
PAI
TGAI
TGAI
All
All
All
All
All
All
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yes
Yes
Yes
YeslO/
Yesll/
Yes
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
Other Requirements;
64-1 - Submittal of Samples
N/A
N/A
N/A
N/A
No
\J Not applicable. Although product Chemistry data may have been submitted in the past, the Agency has determined
that these data must be resubmitted for each pesticide. New requirements have been introduced and previously
submitted data must be updated. Therefore, bibliographic citations for the old data are not applicable.
2/ The nominal concentration for each active ingredient, and the names of each impurity for which a certified
limit is required must be submitted.
3/ Complete information must be provided regarding the nature of the process (batch or continuous), the relative
amounts of beginning materials and the order in which they are added, the chemical equations for each intended
reaction, equipment used to produce each intermediate and the final product, reaction conditions, the duration
of each step of the process, purification procedures, and quality control measures. In addition, the name
and address of the manufacturer, producer, or supplier or each beginning material must be provided, along
with information regarding the properties of each beginning material used to manufacture each product.
40
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ASULAM
§158.120 Product Chemistry (Continued);
_4/ A detailed discussion of all impurities that are or may be present at >Q*1%, based on knowledge of the beginning
materials, chemical reactions (intended and side) in the manufacturing process, and any contamination during
and after production must be submitted.
5/ Five or more representative samples must be analyzed for the amount of active ingredient and each impurity present
at 2P«1% (w/w). Complete validiation data (accuracy, precision) must be submitted for each analytical method used.
6/ For each registered technical, upper and lower limits for asulam, and upper limits for each impurity present
at 2.0*1* (w/w), and for each "toxicologically significant" impurity present at <0.1% (w/w) must be
provided, certified, and validated by sample analysis using( analytical procedures for which accuracy
and precision data have been provided. Certifications must be submitted on EPA Form 8570, Rev. 2/85.
TJ For each registered technical, analytical methods to determine the active ingredient and each toxicologically
significant impurity for which a certified limit is required must be submitted. Each method must be
accompanied by validation studies indicating its accuracy and precision, so as to be suitable for
enforcement of certified limits.
&/ Data needed if the technical chemical is a solid at room temperature.
9/ Data needed if the technical chemical is a liquid at room temperature.
10/ Required if the technical chemical is organic and non-polar.
ll/ Required if the test substance is dispersible with water.
41
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ASULAM
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must
Additional
Data Be
Submitted?
Time Frame
for
Submissionl/
§158.125 Residue Chemistry
171-4 - Nature of the Residue
(Metabolism)
- Plants
PAIRA
Yes
- Livestock
171-4 - Residue Analytical
Method
- Plant residues
- Animal residues
PAIRA
TGAI and
Metabolites
Partially
Partially
00024737
00044583
00052.044
00056424
00056425
00113828
00044580
00056422
00098551
00004821
00004822
00044584
00056432
00056435
00056436
00056438
00056439
00056440
00084804
00084790
00098545
00098547
00098548
00098550
00098552
00098553
00113827
00113831
No
Yes2/
Yes3/
18 Months
18 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ASULAM
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must
Additional
Data Be
Submitted?
Time Frame
for
Submission!/
158.125 Residue Chemistry Continued;
171-4 - Storage Stability
Data
PAI or TEP
Metabolites
Partially
00052047
00098549
00098551
Yes4/
18 Months
171-4 - Magnitude of the Residue
in Plants -- Miscellaneous
Commodities
- Sugarcane
TEP
Partially
00004821
00004823
00004824
00056441
00056442
00113830
00113836
00113837
00136346
YesV
18 Months
EP
Partially
00056441
00113831
00113836
24 Months
171-4 - Magnitude of the
Residue in Meat/
Milk/Poultry/Eggs
TGAI or Plant
Metabolites
Yes
00052047
00084805
00098553
00113833
Reserved^/
43
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ASULAM
§158.125 Residue Chemistry (Continued);
J_/ For Nature of the Resdlue in Plants and Magnitude of the Residue in Cropsi, the timeframes for submitting
data are 18 or 24 months!, as appropriate commencing with the first planting season following issuance
of this registration standard.
21 Data must be submitted depicting the nature of asulam in. meat', fat I, and meat by-products and eggs of
poultry. Animals must be dosed for at least 3 days at a sufficient levels to insure residue
quantification and identification. Eggs must be collected twice daily during the dosing period
and animals must be sacrificed within 24 hours of the final dose. The distribution and identity
of residues must be determined in eggs', fat and muscle of poultry. Should the metabolism of
asulam in ruminants or poultry be found to differ significantly from that in ratsi, studies on
swine metabolism may be required.
3/ Residues of asulam in or on sugarcane samples must be subjected to analysis by multiresidue
protocols. Protocols for methods I', II, HI^ and IV are available from the National Technical
Information Service!, 52285 Port Royal Roadl, Springfield!, Virginia 22161. The Order No. is
PB 203734/AS.
i\J All residue data requested in the registration standard must be accompanied by data regarding
storage length and conditions of sample storage. The data must also be submitted depicting
the stability of residues of asulam under the conditions and for the time Intervals specified), if
different than those discussed above. In laboratory tests using fortified samples!, the pure
active ingredient and pure metabolites must be used. However, if field-weathered samples
are used', the test substance must be a typical end-use product.
5/ Data must be submitting depicting asulam residues of concern in or on sugarcane harvested 90 days
following the last of two postemergence broadcast applications (using ground and aerial equipment
in separate tests) of the 3.34 Ib/gal SC/L formulation at 3.34 Ib ai/A. Tests must be conducted
in Florida, Hawaii), and Louisianai, which collectively accounted for roughly 96% of total U. S.
sugarcane production in 1985.
6/ Data must be submitting depicting concentration of asulam residues of concern in bagasse, molasses,
and refined sugar processed from sugarcane bearing measurable', weathered residues. If residues
concentrate in any processed product', an appropriate food/feed additive tolerance must be proposed.
TJ Presently, the nature of the residue in animals is not adequately understood. On receipt of the
requested animal metabolism studies the need for and nature of tolerances for residues in animal
commodities will be determined and the need for additional feeding studies evaluated.
44
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TABLE A
GENERIC DATA REQUIREMENTS FOR ASULAM
Test
Data Requirement Substance
§158.130 Environmental Fate
Degradation Studies-Lab:
161-1 - Hydrolysis TGAI or PAIRA
Photodegration ;
161-2 - In water TGAI or PAIRA
161-3 - On soil TGAI or PAIRA
161-4 - In air TGAI or PAIRA
Metabolism Studies- Lab:
162-1 - Aerobic Soil TGAI or PAIRA
162-2 - Anaerobic Soil TGAI or PAIRA
162-3 - Anaerobic Aquatic TGAI or PAIRA
162-4 - Aerobic Aquatic TGAI or PAIRA
Mobility Studies:
163-1 - Leaching and TGAI or PAIRA
Adsorption/Desorption
163-2 - Volatility (Lab) TEP
163-3 - Volatility (Field) TEP
Use Does EPA
Pattern Have Data?
A,B,D,G,H No
A,B,D,G No
A,G No
A No
A,B,G,H No
A No
D,G No
D No
A,B,D,G,H Partially
A No
A No
Must
Additional
Bibliographic Data Be
Citation Submitted?
Yes
Yes
Yes
No V
Yes
Yes
Yes
Yes
00098525 Yes2/
Nol/
NoJ_/
Time Frame
for
Submission
9 Months
9 Months
9 Months
•
27 Months
27 Months
27 Months
27 Months
12 Months
45
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TABLE A
GENERIC DATA REQUIREMENTS FOR ASULAM
Test
Data Requirement Substance
§158.130 Environmental Fate (Continued)
Dissipation Studies-Field:
164-1 - Soil TEP
164-2 - Aquatic (Sediment) TEP
164-3 - Forestry TEP
1 64-4 - Combination and TEP
Tank Mixes
164-5 - Soil, Long-term TEP
Accumulation Studies:
165-1 - Rotational Crops PAIRA
(Confined)
165-2 - Rotational Crops TEP
(Field)
165-3 - Irrigated Crops TEP
165-4 - In fish TGAI or PAIRA
165-5 - In Aquatic Non target TEP
Organisms
Must
Additional Time Frame
Use Does EPA Bibliographic Data Be for
Pattern Have Data? Citation Submitted? Submission
A,B,H No Yes3/ — Months
D No • Yes 27 Months
G . No Yes 27 Months
No1/
A No Reserved ^/
A No Yes 39 Months
A No Yes5/ 50 Months
D No Yes6/ 39 Months
A,B,D,G No No7/
D,G No No8/
\J Data are not required to support current registered uses or are otherwise not applicable to this standard.
2J Additional data are required on the soil degradation products of asulam (aged leaching), and batch
equilibrium studies (adsorption/desorption) are needed on four soil types and a sediment.
46
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ASULAM
§158.130 Environmental Fate (Continued)
3_/ Small scale prospective field leaching studies are required rather than new field dissipation studies.
These will track the movement of asulam and its degradation products in soil, soil-pore water
and shallow ground water in geographical areas of major usage. Protocols must he submitted within
90 days after receipt of this standard for approval before field work is begun. The Agency will provide
the time frame for submission of the final report.
kj Data may be required depending on the results of field dissipation studies and aerobic soil
metabolism studies.
5J Data are required since scientifically sound studies indicate that residues occur in rotated crops.
If significant residues are found in rotated crops planted, more than one year after application of
assulam1, tolerances for rotated crops will be needed.
6/ Data are required because asulam is used on dltchbanks which could serve as the source
of irrigation water.
TJ No data are required because the octanol/water partition coefficient of asulam is significantly
below 1000.
8/ No data are required because asulam does not accumulate significantly in fish tissue.
47
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TABLE A
GENERIC DATA REQUIREMENTS FOR ASULAM
Data
§158.
Acute
81-1
81-2
81-3
81-4
81-5
81-6
81-7
Test
Requirement Substance
1 35 Toxicology
Testing:
- Acute Oral - Rat TGAI
- Acute Dermal TGAI
- Acute Inhalation - TGAI
Rat
- Eye Irritation - TGAI
Rabbit
-Dermal Irritation - TGAI
Rabbit
- Dermal Sehsitization -
Guinea Pig TGAI
- Acute Delayed TGAI
Must
Additional
Use . Does EPA Bibliographic Data Be
Pattern Have Data? Citation Submitted?
No Yes
No Yes
No Yes
Yes 00098534 No
Yes 00098535 No
Yes 00098535 No
No No1 /
Time Frame
for
Submission
9 Months
9 Months
9 Months
Neurotoxicity - Hen
Subchronic Testing;
82-1 - 90-day Feeding -
Rodent
Non-Rodent
TGAI
TGAI
No
No
NojV
Reserved -V
48
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TABLE A
GENERIC DATA REQUIREMENTS FOR ASULAM
Data Requirement
Test
Substance
Use
Pattern
Does EPA
Have Data?
Bibliographic
Citation
Must
Additional
Data Be
Submitted?
Time Frame
for
Submission
§158.135 Toxicology (Continued);
TGAI
82-2 - 21-day Dermal -
Rabbit
82-3 - 90-day Dermal
82-4 - 90-day Inhalation
TGAI
TGAI
82-5 - 90-day Neurotoxicity TGAI
Chronic Testing;
83-1 - Chronic Toxicity - TGAI
2 species:
- Rodent i, and
- Non-rodent (Dog)
83-2 - Oncogenicity - TGAI
2 species:
- Rat (preferred)', and
- Mouse (preferred)
83-3 - Teratogenicity - TGAI
2 Species:
- Rat
- Rabbit
83-4 - Reproduction TGAI
No
No
No
No
Yes
Partially
Yes
No
Yes
Yes
Yes
00098543
00098536
00098543
00098538
00098539
00098540
Yes
No4/
No4/
Nol/
No
Yes3/
No
Yes
No
No
No
12 Months
9 Months
50 Months
49
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TABLE A
GENERIC DATA REQUIREMENTS FOR ASULAM
Data Requirement
Test
Substance
Use
Pattern
Does EPA
Have Data?
Bibliographic
Citation
Must
Additional
Data Be
Submitted?
Time Frame
for
Submission
§158.135 Toxicology (Continued)
Mutagenicity Testing:
TGAI
84-2 - Gene Mutation
(Ames Test)
84-2 - Chromosomal
Aberration
84-2 - Other Mechanisms
of Mutagenicity
Special Testing;
85-1 - General Metabolism
TGAI
TGAI
No
Partially
Yes
00082250
00098542
Yes
Yes5/
No
9 Months
12 Months
PAI or PAIRA
No
Yes
24 Months
\J There is no evidence of neurotoxic effects in mammallam species from exposure to asulam. Therefore I, this study
is not required.
2J The rat chronic toxiclty study satisfies this requirement.
3/ EPA has a six-month dog study which was determined to be supplementary due to data reporting deficiencies.
If the additional information the Agency requires can be provided), this study may be upgraded to satisfy both sub-
chronic and chronic effects in the non-rodent. The following additional data must be submitted: (1) summary
tables for urinalysisi, plasma protein!, coagulation studies!, plasma and brain cholinesterase measurements
(including a measure of variation such as standard error or standard deviation); (2) information on the
sex of the animals in Tables 16 and 18 (mean absolute organ weights and mean organ/bodyweight ratio); and
(3) actual number of tissues examined and individual pathology sheets.
4/ These data are not required because asulam's registered use patterns do not result in significant exposure.
_5_/ If individual animal^data can be provided', this dominant lethal study may be upgraded to^satisfy this requirement,
*J *J
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ASULAM
Data Requirement
§158.140 Reentry Protection
132-1 - Foliar Dissipation
132-1 - Soil Dissipation
133-3 - Dermal Exposure
133-4 - Inhalation Exposure
§158.142 Spray Drift
Test Use
Substance Pattern
TEP
TEP
TEP
TEP
Must
Additional Time Frame
Does EPA Bibliographic Data Be for
Have Data? Citation Submitted? Submission
N/A1/
N/AJ7
N/AJY
N/AJ7
201-1 - Droplet Size
Spectrum
201-1 - Drift Field
Evaluation
TEP
TEP
N/A1/
N/A1/
I/ Data are hot required since existing registered uses of asulam are such that significant exposure to
workers or non-target organisms is not expected.
51
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TABLE A
GENERIC DATA REQUIREMENTS FOR ASULAM
Data Requirement
§158.145 Wildlife and^ Aquatic
Avian and Mammalian Testing:
71 -1 - Avian Oral LDsQ
71-2 - Avian Dietary LCso
71-3 - Wild Mammal Toxicity
71-4 - Avian Reproduction
71 -5 - Simulated and Actual
Field Testing -
Mammals and Birds
Aquatic Organism Testing;
72-1 - Freshwater Fish LCso
72-2 - Acute LCso Freshwater
Invertebrates
72-3 - Acute LCso Estuarine
and Marine Organisms
72-4 - Fish Early Like Stage
Must
Additional
Test Use Does EPA Bibliographic Data Be
Substance Pattern Have Data? Citation Submitted?
Organisms
TGAI A,B,D,G Yes 00056417 No
1
TGAI A,B,D,G Yes 00056419 No
00056418
TGAI A,B,D,G N/A_1/
TGAI A,B,D,G N/A1/
TGAI A,B,D,G, N/A1/
TGAI A,B,D,G Partially 00098505 Yes2/
00056421
TGAI A,B,D,G No Yes
TGAI A,B,D,G Partially 00098508 Yes^/
00098509
TGAI A,B,D,G N/AJ_/
Time Frame
for
Submission
9 Months
9 Months
12 Months
and Aquatic Inverte-
brate Life-Cycle
52
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ASULAM
Test Use
Data Requirement Substance Pattern
§158.145 Wildlife and Aquatic Organisms (Continued)
Aquatic Organism testing (Continued);
72-5 - Fish - Life-Cycle TGAI
72-6 - Aquatic Organism TGAI
Accumulation
72-7 - Simulated or Actual TEP A
Field Testing -
Aquatic Organisms
Does EPA
Have Data?
N/AJV
N/AJY
N/AJ7
Must
Additional Time Frame
Bibliographic Data Be for
Citation Submitted? Submission
\J Since there is no evidence that asulam poses a hazard to birds I, fish(t or mammalian species', these data requirements
are not relevant.
2J A study using a coldwater fish species is required.
3/ The requirement for a shrimp study is satisfied. An oyster study is required. If the freshwater fish LC50 (cold
fish) study demonstrates a low toxicity then the marine fish study can be waived.
53
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TABLE A
GENERIC DATA REQUIREMENTS FOR ASULAM
Test
Data Requirement Substance
§158.155 Nontarget Insect
Nontarget Insect Testing - Pollinators:
Must
Additional
Use Does EPA Bibliographic Data Be
Pattern Have Data? Citation Submitted?
Time Frame
for
Submission
141-1 - Honey Bee acute
contact
TGAI
141-2 - Honey Bee - toxicity TEP
of residues on
foliage
141-4 - Honey bee subacute
feeding study
A,B,G,
A,B,G
Yes
No
00036935
141-5 - Field testing for
pollinators
TEP
A,B,G
No
Nontarget Insect Testing - Aquatic Organisms
142-1 - Acute Toxicity to
Aquatic Insects
142-2 - Aquatic Insect Life-
Cycle Study
143-3 - Simulated or Actual
Field Testing for
Aquatic Insects
143-1 - Nontarget Insect
thru Testing - Predators
143-3 and Parasites
No
Nc-V
Reserved^/
NoV
Reserved^/
Reserved^/
Reserved^/
Reserved^/
\J As data from the acute contact test indicate low toxicity, no further testing is required.
2J Reserved pending development of test methodology.
54
Reserved oenrlinq Anenrv r)pri=>iqn
-ho
1-hp
rpoui rpmpnt-
HP e>c;f-M-ii i
-------
i TABLE A
GENERIC DATA REQUIREMENTS FOR ASULAM
Data Requirement
Test
Substance
Use
Pattern
Does EPA
Have Data?
Bibli ographic
Citation
Must
Additional
Data Be
Submitted?
Time Frame
for
Submission
§158.150 Plant Protection
121-1 TARGET AREA PHYTOTOXICITY TEP
NONTARGET AREA PHYTOTOXICITY
TIER I
122-1 - Seed Germination/ TGAI
Seedling Emergence
122-1 - Vegetative Vigor TGAI
122-1 - Aquatic Plant Growth TGAI
TIER II
123-1 - Seed Germination/ TGAI
Seedling Emergence
123-1 - Vegetative Vigor TGAI
123-1 - Aquatic Plant Growth TGAI
B,D,G
B,D,G
B,D,G
B,D,G
B,D,G
B,D,G
No
No
No
No
No
No
No
No1/
Reserved^/
Reserved_/
Reserved^/
Reserved^/
Reserved_/
Reserved^/
55
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TABLE A
GENERIC DATA REQUIREMENTS FOR ASULAM
Data
§158.
124-1
124-2
Test Use Does EPA
Requirement Substance Pattern Have Data?
150 Plant Protection
TIER III
- Terrestrial Field TEP B,D,G No
-Aquatic Field TEP B,D>,G No
Must
Additional
Bibliographic Data Be
Citation Submitted?
Reserved^/
Reserved^/
Time Frame
for
Submission
I/ Data are required only on a case-by-case basis.
2/ Growth and reproduction of aquatic plants seed germination/seedling emergence and vegetative vigor studies are
reserved pending the results of asulam half-life in water and vapor pressure.
2/ Reserved pending results of Tier I.
4/ Reserved pending results of Tier II.
56
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING ASULAM
Data Requirement
Test
Substance
Use
Pattern
Does EPA
Have Data?_T/
Bibliographic
Citationiy
Must
Additional
Data Be
Submitted?
Time Frame
for
Submission
§158.120 Product Chemistry
Product Identity and Composition;
61-1 - Product Identity and MP
Disclosure of Ingredients
61-2 - Description of Beginning MP
Materials and Manufacturing
Process
61-3 - Discussion of Formation MP
of Impurities
Analysis and Certification of
Product Ingredients;
62-1 - Preliminary Analysis of MP
Product Samples
62-2 - Certification of Ingre- MP
dient Limits
62-3 - Analytical Methods to MP
Verify Certified Limits
Physical and Chemical Characteristics;
63-2 - Color MP
63-3 - Physical State MP
63-4 - Odor MP
63-7 - Density, Bulk Density, MP
or Specific Gravity
All
All
All
All
All
All
All
All
All
All
No
No
No
No
No
No
No
No
No
No
N/A
N/A
N/A
YesV
Yes^/
YesV
N/A
N/A
N/A
Yes5/
Yes6/
Yes7/
N/A
N/A
N/A
N/A
YesjJ/
Yes£/
YesjB/
Yes8/
6 Months
6 Months
6 Months
12 Months
12 Months
12 Months
6 Months
6 Months
6 Months
6 Months
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING ASULAM
Data Requirement
Test
Substance
Use
Pattern
Does EPA
Have Data?
Bib.liographic
Citation
Must
Additional
Data Be
Submitted?
Time Frame
for
Submission
§158.120 Product Chemistry (Continued)
63-12 - pH MP
63-14 - Oxidizing or MP
Reducing Action
63-15 - Flammability MP
63-16 - Explodability MP
63-17 - Storage Stability MP
63-18 - Viscosity MP
63-19 - Miscibility MP
63-20 - Corrosion MP
Characteristics
Other Requirements;
64-1 - Submittal of Samples N/A
All
All
All
All
All
All
All
All
No
No
No
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yesj3/,jV
Yes8/,10/
Yes8/,ll/
Yes8/,12/
YesjV
Yes8/,13/
Yes8/,14/
YesEI/
N/A
6 Months
6 Months
6 Months
6 Months
15 Months
6 Months
6 Months
15 Months
\J Not applicable. Although product chemistry data may have been submitted in the past, the Agency has determined
that these data must be resubmitted for each pesticide. New requirements have been introduced and previously
submitted data must be updated. Therefore, bibliographic citations for the old data are not applicable.
2J The chemical name and nominal concentration of each impurity for which a certified limit is required must be
submitted. In addition, the chemical name, nominal concentration, Chemical Abstracts Services (CAS) Registry
Number, and purpose of the active ingredient and each intentionally added inert must be provided. For the active
ingredient, the following must also be provided: the product name, trade name and common name; the molecular,
structural, and empirical formulas; the molecular weight or weight range; and any experimental or internally
assigned company code numbers.
58
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING ASULAM
§158.120 Product Chemistry (Continued)
3/ Complete information must be provided regarding the nature of the process (batch or continuous), the relative
amounts of beginning materials and the order in which they are addedi, the chemical equations for each intended
reaction I, equipment used to produce each intermediate and the final product1, reaction conditions', the duration
of each step of the processi, purification procedures(, and quality control measures. In addition!, the name
and address of the manufacturer I, producer!, or supplier of each beginning material must be provided), along with
information regarding the properties of each beginning material used to manufacture each product.
kj A detailed discussion of all impurities that are or may be present at X).l%, based on knowledge of the
beginning materials', chemical reactions (intended and side) in the manufacturing process i, and any
contamination during and after production must be submitted. Certifications should be submitted
on EPA Form 85701, Rev. 2/85.
_5_/ Five or more representative samples must be analyzed for the amount of active ingredient and
each Impurity for which a certified limit is required. Complete validation data (accuracy, precision)
must be submitted for each analytical method used.
6/ Upper and Lower limits for the active ingredient and each intentionally added inert), and upper limits
for each impurity present at >Q.1% (w/w) and each "toxicologically significant" impurity present
at <0.1% (w/w) must be provided I, certified!, and validated by sample analysis using analytical
procedures for which accuracy and precision data have been provided. Limits for impurities not
associated with the active ingredient need be provided only if they are considered to be of
toxicological significancel, regardless of the concentration at which they are present.
Certifications must be submitted on EPA form 8570, Rev. 2-85.
7/ Anaytical methods must be provided to determine the active Ingredient I, and each toxicologically
significant impurity and intentionally added inert for which certified limits are required.
Each method must be accompanied by validation studies indicating its accuracy and precision.
These methods must be suitable for enforcement of certified limits.
S/ Physicochemical characteristics (color1, physical state I, odor, specific gravity^ pHi, oxidizing or
reducing action), flammabilityi, explosivityl, storage stability!, viscosity, miscibility, and
corrosion characteristics) as required in 40 CFR 158.120 and more fully described in the
Pesticide Assessment Guidelines, Subdivision D must be submitted.
9/ Required if the test substance is dispersible with water.
10/ Required if the product contains an oxidizing or reducing agent.
ll/ Required if the product contains combustible liquids.
59
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TABLE B x
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING ASULAM
§158.120 Product Chemistry (Continued)
12/ Required if the product is potentially explosive.
13/ Required if the product is a liquid.
14 / Required if the product is a liquid and is to be diluted with petroleum solvents.
60
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING ASULAM
•
Test
Data Requirement Substance
§158.135 Toxicology
Acute Testing
81-1 - Acute Oral - Rat MP
81-2 - Acute Dermal MP
81-3 - Acute Inhalation - MP
Must
Additional
Use Does EPA Bibliographic Data Be
Pattern Have Data? Citation Submitted?
All No Yes
All No " Yes
All No Yes
Time Frame
for
Submission
6 Months
6 Months
6 Months
Rat
81-4 - Primary Eye
Irritation - Rabbit
MP
All
No
Yes
6 Months
81-5 - Primary Dermal
Irritation - Rabbit
MP
All
No
Yes
6 Months
81-6 - Dermal Sensitization
Guinea Pig
MP
All
No
Yes
6 Months
61
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APPENDIX II
LABELING
62
-------
SUMMARY-1
LABEL CONTENTS
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 CFR 162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency.
[40 CFR 162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
[40 CFR 162.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. [40 CFR 162.10(g)]
63
-------
SUMMARY-2
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations,, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 . 12 point 8 point
above 15 to 30 ' 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. [40 CFR 162.10(h)(1)(ii)]
Item 7Bo SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. [40 CFR 162.10 (h)(l)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. [40 CFR 162.10(h)(1)(i)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. [40 CFR 162.10(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 162.10(h)(l)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 162.10(h)(2)].
64
-------
SUMMARY-3
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 162.10(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 162.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria
in the PHYS/CHEM Labeling Appendix. The requirement is
based on the results of the flashpoint determinations and
flame extension tests required to be submitted for all products.
These statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is
used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR 162.11(c). You will be notified of
the Agency's classification decision.
65
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SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in 40
CFR 162.rO(h)(1)(iv)
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if specified
in Section I). ' If use is restricted to certified applicators,
the following statement is required: "For retail sale
to and use only by Certified Applicators or persons
under their direct supervision and only for those uses
covered by the Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses that
are unrestricted, but you may not distinguish them
on .the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
66
-------
SUMMARY-5
Item 10A. -REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[40 CFR 162.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
accepted in connection with registration of the product. It
should be made part of the response to this notice and submitted
for review.
67
-------
SUMMARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
fKKf'EKKKL)
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.
-------
SUMMARY-7
ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precaut ionary
statements
Hazards to
hunans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion 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.
ON
SO
-------
SUMMARY-8
ITEM
8C
9A
9B
10A
10B
loc
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terras of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statanent is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling."
Must be set apart and clearly distin-
guishable from from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
o
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Chapter 1—Environmental Protection Agency
$162.10 Labeling requirements.
(a) General—(1) Contents of the label. Every pesticide
product shall bear a label containing the information specified by
the Act and the regulations in this Part. The contents of a
label must show clearly and prominently the following:
(i) The name, brand, or trademark under which the product is
sold as prescribed in paragraph (b) of this section;
(ii) The name and address of the producer, registrant, or
person for whom produced as prescribed in paragraph (c) of this
section;
(iii) The net contents as prescribed in paragraph (d) of this
section;
(iv) The product registration number as prescribed in paragraph
(e) of this section;
(v) The producing establishment number as prescribed in para-
graph (f) of this section;
(vi) An ingredient statement as prescribed in paragraph (g) of
this section;
(vii) Warning or precautionary statements as prescribed in
paragraph (h) of this section;
(viii) The directions for use as prescribed in paragraph (i)
of this section; and
(ix) The use classification(s) as prescribed in paragraph (j)
of this section.
(2) Prominence and legibility. (i) All words, statements,
graphic representations, designs or other information required on
the labeling by the Act or the regulations in this part must be
clearly legible to a person with normal vision, and must be placed
with such conspicuousness (as compared with other words, state-
ments, designs, or graphic matter on the labeling) and expressed
in such terms as to render it likely to be read and understood
by the ordinary individual under customary conditions of purchase
and use.
(ii) All required label text must:
(A) Be set in 6-point or larger type;
(B) Appear on a clear contrasting background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required label or labeling text
shall appear in the English language. However, the Agency may
require or the applicant may propose additional text in other
languages as is considered necessary to protect the public. When
additional text in another language is necessary, all labeling
requirements will be applied equally to both the English and
other-language versions of the labeling.
(4) Placement of Label—(i) General. The label shall appear
on or be securely attached to the immediate container of the
7.1
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pesticide product. For purposes of this Section, and the mis-
branding provisions of the Act, "securely attached" shall mean
that a label can reasonably be expected to remain affixed during
the foreseeable conditions and period of use. If the immediate
container is enclosed within a wrapper or outside container
through which the label cannot be clearly read, the label must
also be securely attached to such outside wrapper or container,
if it is a part of the package as customarily distributed or
sold.
(ii) Tank cars and other bulk containers—(A) Transportation.
While a pesticide product is in transit, the appropriate
provisions of 49 CFR Parts 170-189, concerning the transportation
of hazardous materials, and specifically those provisions con-
cerning the labeling, marking and placarding of hazardous materials
and the vehicles carrying them, define the basic Federal require-
ments. In addition, when any registered pesticide product is
transported in a tank car, tank truck or other mobile or portable
bulk container, a copy of the accepted label must be attached to
the shipping papers, and left with the consignee at the time of
delivery.
(B) Storage. When pesticide products are stored in bulk
containers, whether mobile or stationary, which remain in the
custody of the user, a copy of the label of labeling, including
all appropriate directions for use, shall be securely attached to
the container in the immediate vicinity of the discharge control
valve.
(5) False or misleading statements. Pursuant to section
2(q)(1)(A)•of the Act, a pesticide or a device declared subject
to the Act pursuant to S 162.15, is misbranded if its labeling is
false or misleading in any particular including both pesticidal
and non-pesticidal claims. Examples of statements or representations
in the labeling which constitute misbranding include:
(i) A false or misleading statement concerning the composition
of the product;
(ii) A false or misleading statement concerning the effectiveness
of the product as a pesticide or device;
(iii) A false or misleading statement about the value of the
product for purposes other than as a pesticide or device;
(iv) A false or misleading comparison with other pesticides or
devices;
(v) Any statement directly or indirectly implying that the
pesticide or device is recommended or endorsed by any agency of
the Federal Government;
(vi) The name of a pesticide which contains two or more
principal active ingredients if the name suggests one or more but
not all such principal active ingredients even though the names
of the other ingredients are stated elsewhere in the labeling;
(vii) A true statement used in such a way as to give a false
or misleading impression to the purchaser;
(viii) Label disclaimers which negate or detract from labeling
statements required under the Act and these regulations;
72
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(ix) Claims as to the safety of the pesticide or its ingredients,
including statements such as "safe," "nonpoisonous," "noninjurious,"
"harmless" or "nontoxic to humans and pets" with or without such
a qualifying phrase as "when used as directed"; and
(x) Non-numerical and/or comparative statements on the safety
of the product, including but not limited to:
(A) "Contains all natural ingredients";
(B) "Among the least toxic chemicals known"
(C) "Pollution approved"
(6) .Final printed labeling. (i) Except as provided in
paragraph (a)(6)(ii) of this section, final printed labeling must
be submitted and accepted prior to registration. However, final
printed labeling need not be submitted until draft label texts
have been provisionally accepted by the Agency.
(ii) Clearly legible reproductions or photo reductions will be
accepted for unusual labels such as those silk-screened directly
onto glass or metal containers or large bag or drum labels. Such
reproductions must be of microfilm reproduction quality.
(b) Name, brand, or trademark. (1) The name, brand, or
trademark under which the pesticide product is sold shall appear
on the front panel of the label.
(2) No name, brand, or trademark may appear on the label which:
(i) Is false or misleading, or
(ii) Has not been approved by the Administrator through
registration or supplemental registration as an additional name
pursuant to S 162.6{b)(4).
(c) Name and- address of producer, registrant, or person for
whom produced. An unqualified name and address given on the
label shall be considered as the name and address of the producer.
If the registrant's name appears on the label and the registrant
is not the producer, or if the name of the person for whom the
pesticide was produced appears on the label, it must be'qualified
by appropriate wording such as "Packed for ***," "Distributed by
***," or "Sold by ***" to show that the name is not that of the
producer.
(cl) 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 liqu.id and solid, the net content
statement shall be in terms of weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be stated in terms of the
largest suitable units, i.e., "1 pound 10 ounces" rather than
"26 ounces."
73
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(5) In addition to the required units specified/ net content
may be expressed in metric units.
(6) Variation above minimum content or around an average is
permissible only to the extent that it represents deviation
unavoidable in good manufacturing practice. Variation below a
stated minimum is not permitted. In no case shall the average
content of the packages in a shipment fall below the stated
average content.
(e) Product registration number. The registration number
assigned to the pesticide product at the time of registration
shall appear on the label, preceded by the phrase "EPA Registration
No.," or the phrase "EPA Reg. No." The registration number shall
be set in type of a size and style similar to other print on that
part of the label on which it appears and shall run parallel to
it. The registration number and the required identifying phrase
shall not appear in such a manner as to suggest or imply
recommendation or endorsement of the product by the Agency.
(f) Producing establishments registration number. The producing
establishment registration number preceded by the phrase "EPA
Est.", of the final establishment at which the product was produced
may appear in any suitable location on the label or immediate
container. It must appear on the wrapper or outside container of
the package if the EPA establishment registration number on the
immediate container cannot be clearly read through such wrapper
or container.
(g) Ingredient statement—(1) General. The label of each
pesticide product must bear a statement which contains the name
and percentage by weight of each active ingredient, the total
percentage by weight of all inert ingredients; and if the pesticide
contains arsenic in any form, a statement of the percentages of
total and water-soluble arsenic calculated as elemental arsenic.
The active ingredients must be designated by the term "active
ingredients" and the inert ingredients by the term "inert *
ingredients," or the singular forms of these terms when appropriate.
Both terms shall be in the same type size, be aligned to the same
margin and be equally prominent. The statement- "Inert Ingredients,
none" is not required for pesticides which contain 100 percent
active ingredients. Unless the ingredient statement is a complete
analysis of the pesticide, the term "analysis" shall not be used
as a heading for the ingredient statement.
(2) Position of ingredient statement, (i) The ingredient
statement is normally required on the front panel of the label.
If there is an outside container or wrapper through which the
ingredient statement cannot be clearly read, the ingredient
statement must also appear on such outside container or wrapper.
If the size or form of the package makes it impracticable to place
the ingredient statement on the front panel of the label, permission
may be granted for the ingredient statement to appear elsewhere.
(ii) The text of the ingredient statement must run parallel
with other text on the panel on which it appears, and must be
clearly distinguishable from and must not be placed in the body
of other text.
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(3) Names to be used in ingredient statement. The name used
for each ingredient shall be the accepted common name, if there
is one, followed by the chemical name. The common name may be
used alone only if it is well known. If no common name has been
established, the chemical name alone shall be used. In no case
will the use of a trademark or proprietary name be permitted unless
such name has been accepted as a common name by the Administrator
under the authority of Section 25(c)(6).
(4) Statements of percentages. The percentages of ingredients
shall be stated in terms of weight-to-weight. The sum of per-
centages of the active and the inert ingredients shall be 100.
Percentages shall not be expressed by a range of values such as
"2.2-25%." If the uses of the pesticide product are expressed as
weight of active ingredient per unit area, a statement of the
weight of active ingredient per unit volume of the pesticide
formulation shall also appear in the ingredient statement.
(5) Accuracy of stated percentages. The percentages given
shall be as precise as possible reflecting good manufacturing
practice. If there may be unavoidable variation between manu-
facturing batches, the value stated for each active ingredient
shall be the lowest percentage which may be present.
(6) Deterioration. Pesticides which change in chemical
composition significantly must meet the following labeling re-
quirements:
(i) In cases where it is determined that a pesticide formulation
changes chemical composition significantly, the product must bear
the following statement in a prominent position on the label: "Not
for sale or use after [date]."
(ii) The product must meet all label claims up to the expiration
time indicated on the label.
(7) Inert ingredients. The Administrator may require the name
of any inert ingredient(s) to be listed in the ingredient statement
if he determines that such ingredient(s) may pose a hazard to man
or the environment.
(h) Warnings and precautionary statements. Required warnings
and precautionary statements concerning the general areas of
toxicological hazard including hazard to children, environmental
hazard, and physical or chemical hazard fall into two groups; those
required on the front panel of the labeling and those which may
appear elsewhere. Specific requirements concerning content,
placement, type size, and prominence are given below.
(1) Required front panel statements. With the exception of the
child hazard warning statement, the text required on the front
panel of the label is determined by the Toxicity Category of the
pesticide. The category is assigned on the basis of the highest
hazard shown by any of the indicators in the table below:
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Hazard Indicators
Oral LD5Q
Inhalation LC
Dermal LD
Eye effects
Skfn effects
1
Up to and
Including
50 mg/kg
Up to and
Including
.2 mg/l Iter
Up to and
Including
200 mgAg
Corrosive;
cornea 1 opacity
not reversible
within 7 days
Corrosive
Toxicity c
II
From 50 thru
500 mg/kg
From .2 thru
2 mg/l Iter
From 200
thru 2000
Cornea 1 opacity
reversible
within 7 days;
Irritation
persisting for
7 days
Severe Irritation
at 72 hours
:ategorles
III
From 500 thru
5000 mg/kg
From 2 thru
20 mg/l Iter
From 2,000 thru
20,000
No cornea 1 opacity;
Irritation
reversible
within 7 days
Moderate Irritation
at 72 hours
IV
Greater than
5000 mg/kg
Greater than
20 mg/l Iter
Greater than
20,000
No Irritation
Mild or slight
Irritation at
72 hours
(i) Human hazard signal word.—(A) Toxicity Category I. All
pesticide products meeting the criteria of Toxicity Category I
shall bear on the front panel the signal word "Danger." In
addition _if the product was assigned to Toxicity Category I on
the basis of its oral, inhalation or dermal toxicity (as distinct
from skin and eye local effects) the word "Poison" shall appear
in red on a background of distinctly contrasting color and the
skull and crossbones shall appear in immediate proximity to the
word "poison."
All pesticide products meeting the
(B) Toxicity Category II.
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."
II shall bear on the front panel'
All pesticide
III shall bear
All pesticide
IV shall bear
products meeting the
on the front panel
products meeting the
on the front panel
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(E) Use of signal words. Use of any signal word(s) associated
with a higher Toxicity Category is not permitted except when the
Agency determines that such labeling is necessary to prevent
unreasonable adverse effects on man or the environment. In no
case shall more than one human hazard signal word appear on the
front panel of a label.
(ii) Child hazard warning. Every pesticide product label shall
bear on the front panel the statement "keep out of reach of
children." Only in cases where the likelihood of contact with
children during distribution, marketing, storage or use is
demonstrated by the applicant to be extremely remote, or if the
nature of the pesticide is such that it is approved for use on
infants or small children, may the Administrator waive this
requirement.
( i i i ) Statement of practical treatment—(A) Toxicity
Category I. A statement of practical treatment (first aid or
other) shall appear on the front panel of the label of all
pesticides falling into Toxicity Category I on the basis of oral,
inhalation or dermal toxicity. The Agency may, however, permit
reasonable variations in the placement of the statement of
practical treatment is some reference such as "See statement of
practical treatment on back panel" appears on the front panel
near the word "Poison" and the skull and crossbones.
(B) Other toxicity categories. The statement of practical
treatment is not required on the front panel except as described
in paragraph (h)(1)(iii)(A) of this section. The applicant may,
however, include such a front panel statement at his option.
Statements of practical treatment are, however, required elsewhere
on the label in accord with paragraph (h)(2) of this section if
they do not appear on the front panel.
(i.v) Placement and prominence. All the required front panel
warning statements shall be grouped together on the label, and
shall appear with sufficient prominence relative to other front
panel text and graphic material to make them unlikely to be over-
looked under customary conditions of purchase and use. The
following table shows the minimum type size requirements for the
front panel warning statements on various sizes of labels:
Size of label front panel
in square inches
Points
Required
signal word,
all capitals
i :.' 6
10
1 12
14
18
"Keep but
of reach of
Children"
6
6
8
10
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."
(i) Hazard to humans and domestic animals. (A) Where a hazard
exists to humans or domestic animals, precautionary statements
are required indicating the particular hazard, the route(s) of
exposure and the precautions to be taken to avoid accident, injury
or damage. The precautionary paragraph shall be immediately
preceded by the appropriate hazard signal word.
(B) The following table depicts typical precautionary.statements.
These statements must be modified or expanded to reflect specific
hazards.
Toxic Ity
category
Precautionary statements by toxic Ity category
Oral, Inhalation, or dermal toxlctty
Skin and eye local effects
I
II .
Ill
IV
Fatal (poisonous) If swallowed I Inhaled or
absorbed through skin). Do not breathe
vapor IdustJ or spray mist). Dp not get
In eyes, on skin, or on clothing (Front
panel statement of practical treatment
required.).
Corrosive, causes eye and skin damage lor
skin Irritation). Do not get In eyes, on
skin, or on clothing. Wear goggles or face
shield and rubber gloves when handling.
Harmful or fatal If swallowed.
(Appropriate first aid statement required.)
May be fatal If swallowed (Inhaled or Causes eye land skin) Irritation. Do not
absorbed through the skin). Do not breathe get In eyes, on skin, or on clothing.
vapors (dust or spray Mist). Do not get 1n| Harmful If swallowed. (Appropriate first
eyes, on skin, or on clothing. (Appropriate) aid statement required.].
first aid statements required.!.
Harmful If swallowed (Inhaled or absorbed
through the skin). Avoid breathing vapors
(dust or spray mist). Avoid contact with
skin (eyes or clothing). (Appropriate
first aid statement required.).
(No precautionary statements required.).
Avoid contact with skin, eyes or clothing.
In case of contact Immediately flush
eyes or skin with plenty of water. Get
medical attention If Irritation persists.
(No precautionary statements required.).
(ii) Environmental hazards, iWhere 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
78
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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 LD$Q of 100 or less, the
statement "This Pesticide is Toxic to Wildlife" is required.
(B) If a pesticide intended for outdoor use contains an active
ingredient with a fish acute LC$Q of 1 ppm or less, the statement
"This Pesticide is Toxic to Fish" is required.
(C) If a pesticide intended for outdoor use contains an active
ingredient with an avian acute oral LD$Q of 100 mg/kg or less, or
a subacute dietary LCso of 50° PPm or less, the statement "This
Pesticide is Toxic to Wildlife" is required.
(D) If either accident history or field studies demonstrate
that use of the pesticide may result in fatality to birds, fish
or mammals, the statement "This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar application to agricultural
crops, forests, or shade trees, or for mosquito abatement
treatments, pesticides toxic to pollinating insects must bear
appropriate label cautions.
(F) For all outdoor uses other than aquatic applications the
label must bear the caution "Keep out of lakes, ponds or streams.
Do not contaminate water by cleaning of equipment or disposal of
wastes."
(iii) Physical or chemical hazards. Warning statements on the
flammability or explosive characteristics of the pesticide are
required as follows:
Flash point
Required text
(A) PRESSURIZED CONTAINERS
Flash point at or below 20*F; If there Is a
flashback at any valve opening.
Flash point above 20*F and not over 80"F or If
the flame extension Is •ore than 18 In. long
at a distance of 6 In. fro* the flame.
Extremely flammable. Contents under pressure.
Keep away from fire, sparks, and heated
surfaces. Do not puncture or Incinerate
container. Exposure to temperatures above
130*F nay cause bursting.
Flammable. Contents under pressure. Keep away
from heat, sparks, and open flame. Do not
puncture or Incinerate container. Exposure to|
temperatures above 130"F may cause bursting.
Contents under pressure. Do not use or store
near heat or open flame. Do not puncturfe or
Incinerate container. Exposure to tempera-
tures above 130'F may cause bursting.
(B) NONPRESSURIZED CONTAINERS
Extremely flammable. Keep away from fire, '
sparks, and heated surfaces.
Flammable. Keep away from heat and open flame.
Do not use or store near heat or open flame.
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(i) Directions for Use—(1) General requirements—(i) Adequacy
and clarity of directions. Directions for use must be stated in
terms which can be easily read and understood by the average
person likely to use or to supervise the use of the pesticide.
When followed, directions must be adequate to protect the public
from fraud and from personal injury and to prevent unreasonable
adverse effects on the environment.
(ii) Placement of directions for use. Directions may appear
on any portion of the label provided that they are conspicuous
enough to be easily read by the user of the pesticide product.
Directions for use may appear on printed or graphic matter which
accompanies the pesticide provided that:
(A) If required by the Agency/ such printed or graphic matter
is securely attached to each package of the pesticide, or placed
within the outside wrapper or bag;
(B) The label bears a reference to the directions for use in
accompanying leaflets or circulars, such as "See directions in
the enclosed circular." and
(C) The Administrator determines that it is not necessary for
such directions to appear on the label.
(iii) Exceptions to requirement for direction for use—(A)
Detailed directions for use may be omitted from labeling of
pesticides which are intended for use only by manufacturers of
products other than pesticide products in their regular manu-
facturing processes, provided that:
(_!) The label clearly shows that the product is intended for
use only in manufacturing processes and specifies the type(s) of
products involved.
(2) Adequate information such as technical data sheets or
bulletins, is available to the trade specifying the type of
product involved and its proper use in manufacturing processes;
(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
environment.
(B) Detailed directions for use may be omitted from the labeling
of pesticide products for which sale is limited to physicians,
veterinarians, or druggists, provided that:
(I) 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:
(1) There is information readily available to the formulators
on the composition, toxicity, methods of use, applicable restrictions
or limitations, and effectiveness of the product for pesticide
purposes;
80
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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 is registered; and
(£) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(2) Contents of Directions for Use. The directions for use
shall include the following, under the headings "Directions for
Use " :
(i) The statement of use classification as prescribed in
162.10(j) immediately under the heading "Directions for Use."
(ii) Immediately below the statement of use classification,
the statement "It is a violation of Federal law to use this
product in a manner inconsistent with its labeling."
(iii) The site(s) of application, as for example the crops,
animals, areas, or objects to be treated.
(iv) The target pest(s) associated with each site.
(v) The dosage rate associated with each site and pest.
(vi) The method of application, including instructions for
dilution, if required, and type(s) of application apparatus or
equipment requried.
(vii) The frequency and timing of applications necessary to
obtain effective results without causing unreasonable adverse
effects on the environment.
(viii) Specific limitations on reentry to areas where the
pesticide has been applied, meeting the requirements concerning
reentry provided by 40 CFR Part 170.
(ix) Specific directions concerning the storage and disposal
of the pesticide and its container, meeting the requirements of
40 CFR Part 165. These instructions shall be grouped and appear
under the heading "Storage and Disposal." This heading must be
set in type of the same minimum sizes as required for the child
hazard warning (See Table in $ 162.10(h)(1)(iv).)
(x) Any limitations or restrictions on use required to prevent
unreasonable adverse effects, such as:
(A) Required intervals between application and harvest of food
or feed crops.
(B) Rotational crop restrictions.
(C) Warnings as required against use on certain crops, animals,
objects,; or in or adjacent to certain areas.
(D) ^Reserved]
(E) For restricted use pesticides, a statement that the
pesticide may be applied under the direct supervision of a
certified applicator who is not physically present at the site of
application but nonetheless available to the person applying the
pesticide, unless the Agency has determined that the pesticide
may only be applied under the direct supervision of a certified
applicator who is physically present.
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(F) Other pertinent information which the Administrator
determines to be necessary for the protection of man and the
environment.
(j) Statement of Use Classification. By October 22, 1976, all
pesticide products must bear on their labels a statement of use
classification as described in paragraphs (j)(l) and (2) of this
section. Any pesticide product for which some uses are classified
for general use and others for restricted use shall be separately
labeled according to the labeling standards set forth in this
subsection, and shall be marketed as separate products with
different registration numbers, one bearing directions only for
general use(s) and the other bearing directions for restricted
use(s) except that, if a product has both restricted use(s) and
general use(s), both of these uses may appear on a product labeled
for restricted use. Such products shall be subject to the
provisions of § 162.10(j) ( 2).
(1) General Use Classification. Pesticide products bearing
directions for use(s) classified general shall be labeled with
the exact words "General Classification" immediately below the
heading "Directions for Use." And reference to the general
classification that suggests or implies that the general utility
of the pesticide extends beyond those purposes and uses contained
in the Directions for Use will be considered a false or misleading
statement under the statutory definitions of misbranding.
(2) Restricted Use Classification. Pesticide products bearing
direction for use(s) classified restricted shall bear statements
of restricted use classification on the front panel as described
below:
(i) Front panel statement of restricted use classification.
(A) At the top of the front panel of the label, set in type of
the same minimum sizes as required for human hazard signal words
(see table in § 162.10(h)(1)(iv)), and appearing with sufficient
prominence relative to other text and graphic material on the
front panel to make it unlikely to be overlooked under customary
conditions of purchase and use, the statement "Restricted Use
Pesticide" shall appear.
(B) Directly below this statement on the front panel, a summary
statement of the terms of restriction imposed as a precondition
to registration shall appear. If use is restricted to certified
applicators, the following statement is required: "For retail
sale to and use only by Certified Applicators or persons under
their direct supervision and only for those uses covered by the
Certified Applicator's certification." If, however, other
.regulatory restrictions are imposed, the Administrator will define
,the appropriate wording for the terms of restriction by regulation,
(k) Advertising. [Reserved]
[40 PR 28268, July 3, 1975; 40 PR 32329, Aug. 1, 1975; 40 PR
38571, Aug. 21, 1975, as amended at 43 PR 5786, Feb. 9, 1978]
82
-------
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. All Other Pressurized
Containers
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
83
-------
STOR-1
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading; .
All products are required to bear -specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL."
Storage Instructions;
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs.
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
84
-------
PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for
domestic use, must bear explicit.instructions about pesticide
disposal. The statements listed below contain the exact wording .
that must appear on the label of these products.
1. The labels of all products, except domestic use, must contain
the statement:
"Do not contaminate water, food, or feed by storage or
disposal."
2. Except those products intended solely for domestic use, the
labels of all products that contain active ingredients that
are Acute Hazardous Wastes or are assigned to Toxicity Cate-
gory I on the basis of oral or dermal toxicity, or Toxicity
Category I or II on the basis of acute inhalation toxicity
must bear the following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper dis-
posal of excess pesticide, spray mixture, or rinsate is
a violation of Federal Law. If these wastes cannot be
disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control
Agency, or the Hazardous Waste representative at the
nearest EPA Regional Office for guidance."
3. The labels of all products, except those intended for domestic
use, containing active or inert ingredients that are Toxic
Hazardous Wastes or meet any of the criteria in 40 CFR 261,
Subpart C for a hazardous waste must bear the following
pesticide disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Federal Law. If these wastes cannot be disposed of by
use according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office
for guidance."
4. Labels for all other products, except those intended for domes-
tic use, must bear the following pesticide disposal statement:
"Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposal
facility."
5. Products intended for domestic use only must bear the following
disposal statement:
"Securely wrap original container in several layers of
newspaper and discard in trash."
85
-------
CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear one of the following
container disposal statements:
Container Type
Statement
Non-aerosol products
(bottles, cans, jars)
Non-aerosol products
(bags)
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. All other products must bear container disposal instructions,
based on container type, listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
Plastic containers
Glass containers
Fiber drums
with liners
Paper ana
plastic bags
Compressed gas
cylinders
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Bnpty 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)
I/ Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
86
-------
APPENDIX III
USE INDEX
87
-------
EPA Index to Pesticide Chemicals
ASULAM, SODIUM SALT T/A//-.:
-J/LT A,'/,/
TABLE OF CONTENTS '
. it. £ n' y
Site Nape Page
TERRESTRIAL FOOD CROP 2
(Agricultural Crops) 2
Sugarcane 2
TERRESTRIAL NONFOOD.CROP 3
(Ornamental Plants and Forest Trees) 3
Andorra Juniper 3
Bermudagrass (Tifway 419) 3
Chinese Juniper 3
Creeping Juniper 3
Intermediate Yew 3
Japanese Tew 3
Juniper 3
Savin Juniper / 3
Shore Juniper 3
St. Augustinegrass 3
Yew 3
Yew Podocarpus 3
(Noncrop, Wide Area, and General Indoor/Outdoor Treatments) 4
Highway Rights-of-Way 4
Noncrop Areas 4
AQUATIC NONFOOD 5
(Aquatic Sites) 5
Ditchbanks 5
FORESTRY 5
Christmas Tree Plantations 5
Conifer Release 5
Forest Plantings (reforestation areas) 5
Issued: 2-24-86 I-106902-i
88
-------
.'-."EPA-Index to Pesticide Chemicals
L06902
ASULAM, SODIUM SALT*
TYPE PESTICIDE: Herbicide
FORMULATIONS; SC/L (3.34 Ib/gal or 36.2% a.i.) '
GENERAL WARNINGS AND LIMITATIONS; A selective herbicide used in sugar-
cane, turf, ornamentals, noncrop areas, and reforestation areas. Do not
apply directly to lakes, streams, or ponds, or contaminate water sources
by cleaning of equipment or disposal of wastes. Apply when weeds are ac-
tively growing. An approved agricultural or non-ionic surfactant may be
used in sugarcane and noncrop areas, respectively. The surfactant may be
added to the finished spray solution at 0.25 percent by volume. Per acre
dosages are for broadcast treatments, unless otherwise noted. For band
or spot treatments, the dosages should be reduced proportionally.
Dosages for this chemical were calculated using the asulam equivalent
(a.e.).
TIME REQUIRED FOR CONTROL; Not located.
PHYTOTOXICITY TO TARGET WEEDS; Not located. '
PHYTOTOXICITY TO CROPS; Not located.
MODE OF ACTION; Inhibits meristematic cell division and expansion.
BROADLEAF WEEDS CONTROLLED;
BFAWBB Canada thistle
BFATBA Rorseweed
BFCXBC Tansy ragwort
GRASSES AND OTHER MONOCOTS CONTROLLED;
CAARBC Alexandergrass
CABHBB Barnyardgrass
CAARBF Broadleaf pan!cum
CACFBL Bull paspalum
CABFAA Crabgrass
CACEBD Fall pan!cum
GACUAA Foxtail
CABIBA Goosegrass
CACOBA Itchgrass
CACWBC Johnsongrass
CABFBF Large crabgrass
CAARBB Faragrass
CAAWAA Sandbur
*sodium salt of methyl sulfanilylcarbamate
Issued: 2-24-86 1-106902-1
89
-------
EBAHBC
EBAHBB
EPA Index to Pesticide Chemicals
ASULAH, SODIUM SALT
NONFLOWERING PLANTS CONTROLLED:
Brackenfern
Western brackenfern
25003AA
Site, Dosage
and Formulation
(Ib a.e./A)
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Sugarcane
Tolerance, Use, Limitations
2.09-3.34
(3.34 Ib/gal SC/L)
000359-00662
2.51-3.34
(3.34 Ib/gal SC/L)
3.34
(3.34 Ib/gal SC/L)
Issued: 2-24-86
0.1 (N) ppm
90 day preharvest interval.
Do not graze or feed sugarcane fodder or forage
to livestock.
Postemergence. Broadcast or band. For control
of alexandergrass, broadleaf panicum, crabgrass,
foxtail, and goosegrass in plant cane or cane
grown from stubble. Use the lower dosage when
grass is less than 8 inches tall, or before seed
head formation. Use the higher dosage when grass
is taller than 8 inches or when grass is in early
seed head formation. A second application may be
made to crabgrass. Apply before seed head forma-
tion.
Postemergence. Broadcast or band. For control
of barnyardgrass in plant cane or cane grown from
stubble. Use the lower dosage when grass is less
than 8 inches tall, and the higher dosage when
grass is taller than 8 Inches. Do not make a sec-
ond application during the growing season.
Postemergence. Broadcast or band. For control
of itchgrass, johnsongrass, and paragrass on plant
cane or cane grown from stubble. Apply when grass
is 6 to 24 Inches tall. Apply in 15 to 100 gal-
lons of water per acre by ground, or 3 to 5 gal-
lons of water per acre by air (except in HI where
5 to 10 gallons of water per acre Is recommended).
A second application may be made to control itch-
grass and johnsongrass. Make the second applica-
tion at a rate of 1.67 to 3.34 pounds active In-
gredient per acre to johnsongrass between 18 and
24 inches tall, and at a rate of 3.34 pounds ac-
tive Ingredient per acre to itchgrass less than
12 inches tall.
1-106902-2
90
-------
Site, Dosage
and Formulation
(Ib a.e./A)
EPA Index to Pesticide Chemicals
ASULAM, SODIUM SALT
Tolerance, Use, Limitations
Sugarcane (continued)
2.51-3.34 Postemergence. Spot treatment. Apply in 100 gal-
(3.34 Ib/gal SC/L) Ions of water. Do not exceed 50 gallons of fin-
ished spray per acre or 3.34 pounds active ingre-
dient per acre per treatment.
TERRESTRIAL NONFOOD CROP
(Ornamental Plants and Forest Trees)
35315AA Andorra Juniper
35155AA Chinese Juniper
35160AA Creeping Juniper
35181AA Intermediate Yew
35072AA Japanese Yew
35073AA Juniper
35205AA Savin Juniper
35209AA Ihore Juniper
35130AA ' Yew
35253AA Yew Podoearpus
3.34
(3.34 Ib/gal SC/L)
000359-00662
Postemergence. Broadcast. For control of barn-
yardgrass, crabgrass, fall panlcum, foxtail,
goosegrass, and horseweed. Make 1 application per
year in a minimum of 20 gallons of water per acre
when weeds are between early seedling and early
seed head formation.
33017AA Bermudagrass (Tifway
~419)
33050AA St. Augustinegrass
2.09
(3.34 Ib/gal SC/L)
000359-00662
33017AA
33050AA
General Information; Do not apply to freshly
mowed turf or to turf under stress. Temporary
turf discoloration may result.
Broadcast.
goosegrass,
For control of bull paspalum, crab-
Make 1 applica-
and sandbur.
tlon per growing season, when weeds are actively
growing. Apply in 20 to 50 gallons of water per
acre.
(Bermudagrass, St. Augustinegrass - golf course fairways and roughs)
[SLN]
1.67-2.09
(3.34 Ib/gal SC/L)
Issued: 2-24-86
SLN - Use limited to FL.
Broadcast. For control of bull paspalum, crab*-
grass, goosegrass, and sandbur. Make 1 applica-
tion per growing season. Apply In 30 to 50 gal-
lons of water per acre. Use the higher dosage
for control of goosegrass.
1-106902-3
91
-------
EPA Index to Pesticide Chemicals
J70040A
ASULAM, SODIUM SALT
Site, Dosage Tolerance, Use, Limitations
and Formulation
(Ib a.e./A)
Bermudagrass (Tifway 419) cluster (continued)
(St. Augustinegrass - for sod production)
[SLN] SLN - Use limited to TX.
2.09 Broadcast. For control of large crabgrass. Apply
(3.34 Ib/gal SC/L) 20 gallons of finished spray per acre. Make 1
application per growing season.
(Noncrop, Wide Area, and General Indoor/Outdoor Treatments)
Highway Rights-of-Way
2.92-3.34 Broadcast. For control of western brackenfern.
(3.34 Ib/gal SC/L) Apply 20 to 100 gallons of finished spray per acre
000359-00662 when the fern is in full frond.
3.34-6.68
(3.34 Ib/gal SC/L)
[SLN]
3.34
(3.34 Ib/gal SC/L)
[SLN]
1.67
(3.34 Ib/gal SC/L)
Noncrop Areas
2.92-3.34
(3.34 Ib/gal SC/L)
000359-00662
Issued: 2-24-86
Broadcast or spot treatment. For control of crab-
grass, johnsongrass, and paragrass. Apply 20 to
100 gallons of finished spray per acre before
grasses reach seed head formation. For Johnson-
grass, apply when the grass is 18 Inches or tall-
er. . Use the higher dosage in heavily infested
areas. In HI, use the higher dosege and apply 100
gallons of finished spray as a spot treatment to
control johnsongrass and paragrass. Do not exceed
50 gallons of total finished spray per acre.
SLN - Use limited to CA (Del Norte County).
Spot treatment. For control of tansy ragwort.
Apply in 25 gallons of water. Make 2 applications
per year. Do not exceed 3 pounds active ingredi-
ent per acre. Spray to wet foliage.
SLN - Use limited to PA.
Broadcast. For control of Canada thistle. Apply
25 gallons of finished spray per acre by ground
or by air when thistle is between early and late
bud stage. Make 1 application per growing season.
General Information; Noncrop Areas include areas
around boundary fences, fencerows, lumberyards,
warehouse lots, utility yards, storage areas, in-
dustrial plant sites, utility, railroad, and pipe-
line rights-of-way.
Broadcast. For control of western brackenfern.
Apply 20 to 100 gallons of finished spray per acre
when the fern is in full frond.
1-106902-4
92
-------
EPA Index to .Pesticide Chemicals
ASULAM, SODIUM SALT
Site, Dosage Tolerance, Use, Limitations
and Formulation
(Ib •a.e.VA) -
Noncrop Areas (continued)
3.34-6.68 Broadcast or spot treatment. For control of crab-
(3. 34 Ib/gal SC/L) grass, johnsongrass, and paragrass. Apply 20 to
100 gallons of finished spray per acre before
grasses reach seed head formation. For Johnson-
grass, apply when the grass is 18 inches or tall-
er. Use the higher dosage in heavily infested
areas. In HI, use the higher dosage and apply 100
gallons of finished spray as a spot treatment to
control johnsongrass and paragrass. Do not exceed
50 gallons of finished spray per acre.
SLN - Use limited to CA (Del Norte County).
3 Spot treatment. For control of tansy ragwort.
(3.34 Ib/gal SC/L) Apply in 25 gallons of water. Make 2 applications
per year. Do not exceed 3 pounds active Ingredi-
ent per acre. Spray to wet foliage.
AQUATIC NONFOOD
(Aquatic Sites)
650130A Dltchbanks
Refer to TERRESTRIAL NONFOOD CROP, (Noncrop, Wide
Area, and General Indoor/Outdoor Treatments), Non-
crop Areas for pest and use Information.
FORESTRY
30005AA Christmas Tree
Plantations Do not graze or feed foliage from treated areas
30004AA Conifer Release to livestock.
30006AA Forest Plantings (re- General Information; Apply In areas where Doug-
forestatlon areas) las-fir, grand fir, nobel fir, or scotch pine are
grown.
3.34 Postemergence. Broadcast. For control of western
(3.34 Ib/gal SC/L) brackenfern. Apply 20 gallons of finished spray
000359-00662 per acre by ground or 10 gallons of finished spray
per acre by air after bud break and hardening, or
firming of new tree growth. Apply when western
brackenfern is in full frond.
Issued: 2-24-86 1-106902-5
93
-------
.' EPA Index to Pesticide Chemicals
ASULAM, SODIUM SALT
Site, Dosage Tolerance, Use, Limitations
and Formulation
(Ib a.e./A)
Christmas Tree Plantations cluster (continued)
[SLN] SLN - Use limited to OR.
1.67-3.34 Postemergence. Broadcast. For control of western
(3.34 Ib/gal SC/L) brackenfern. Apply in 20 gallons of finished
spray per acre by ground or 10 gallons of finished
spray per acre by air after bud break and harden-
ing, or firming of new tree growth. Apply when
western brackenfern is in full frond.
'35189AA (Jeffrey pine, ponderosa pine, red fir, sugar pine, white pine)
'35100AA
'35152AA
'35228AA
'35219AA
[SLN] SLN - Use limited to CA.
3.34 Postemergence. Broadcast. For control of western
(3 Ib/gal SC/L) brackenfern. Apply in 20 gallons of finished*
spray per acre by ground or 10 gallons of finished
spray per acre by air. Apply when western brack-
enfern is in full frond.
Issued: 2-24-86 1-106902-6
94
-------
EPA.Index to Pesticide Chemicals
ASULAM, SODIUM SALT
Listing of Registered Pesticide Products by Formulation
236.2016 36.2% (3.34 Ib a.e./gal) soluble concentrate/liquid
asulam, sodium salt (106902)
000359-00662
(000359-00662) CA810082 CA820028 CT800001 FL770005
FL780028 OR770033 PA810017 TX800005
Issued: 2-24-86 1-106902-7
95
-------
. . •- 'EPA. Index to .Pesticide Chemicals
ASULAM, SODIUM SALT
Auxiliary Documentation
Dennis Szuhay telecon (9-24-86) with Ms. McMullen - decided Juniperus
cuspidata was a mistake and should have been a taxus. It will be removed
in the next label revision.
Issued: 2-24-86 I-106902-a
96
-------
Ch'em. Name:
' '
Chem. No. ;
' A' • • M
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Date:
Product Total from Printout
Tota i
Jackets Requested
Total
Received
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Number
Used *
1
Number
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: 3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
Reg. #
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97
-------
APPENDIX IV
BIBLIOGRAPHY
98
-------
BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
1. CONTENT.OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
99
-------
BIBGUIDE-2
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??) , the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission,
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
100
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Asulam Standard
MRID CITATION
00004821 Rhone-Poulenc, Incorporated (1977) Asulam. Summary of studies
238025-B through 238025-D. (Unpublished study received Apr 13',
1979 under 359-662; prepared in cooperation with Rhodia1, Inc.;
CDL:238025-A)
00004822 Guyton, C.L. (1977) Procedures for the Measurement of Asulam, MCPA,
Sulfanilamide and Acetylasulam in/on Flax: Forages, Straw, Seed
and Mill-Processed Flax Seed Fractions. Method no. 143 dated
Jul 1977. (Unpublished study received Apr 13, 1979 under 359-
662; prepared by Rhodia, Inc., submitted by Rhone-Poulenc, Inc.,
Monmouth Junction, N.J.; CDL:238025-B)
00004823 Carlyle', S. (1977) Sugarcane: Final Report No.: 330977-030. (Un-
published study including final report nos. 330977-031 and
330977-032, received Apr 13, 1979 under 359-662; prepared by
Rhodia, Inc. in cooperation with United States Sugar Corp.', sub-
mitted by Rhone-Poulenc, Inc., Monmouth Junction^ N.J.; CDL:
238025-C)-
00004824 Kirby, M. (1977) Sugarcane: Final Report No.: 281777-013. (Unpub-
lished study including final report nos. 281777-014 and 281777-
015, received Apr 13, 1979 under 359-662; prepared by Rhodia!,
Inc.i, submitted by Rhone-Poulenc, Inc., Monmouth Junction, N.J.;
CDL:238025-D)
00024737 Hilton, H.W.; Normurai, N.S.; Kamedai, S.S.; et al. (1976) Some pat-
terns of herbicide and growth regulator intake1, persistence, and
distribution in sugarcane. Archleves of Environmental Contamina-
tion^and Toxicology 4(4):385-394. (Also ^n_ unpublished submis-
sioTTreceived July 19, 1978 under 201-403; submitted by Shell
Chemical Co., Washington, D.C.; CDL:234470-AP)
00036935 Atkins', E.L.; Greywood, E.A.; Macdonald, R.L. (1975) Toxicity of
Pesticides and Other Agricultural Chemicals to Honey Bees: Labo-
ratory Studies. By University of California, Dept. of Entomolo-
gy. ?: UC, Cooperative Extension. (Leaflet 2287; published
study.)
00044580 Craine', E.M.; Ray, W.H. (1972) Residues in the Milk and Tissues of
Dairy Cows Fed Asulam: Research Report No. EMC 72:27. Includes
methods entitled: Milk residue analysis and Tissue residue anal-
ysis. (Unpublished study received Dec 17, 1975 under 6F1716;
prepared by Hess & Clarki, submitted by Rhodia, Inc., New Bruns-
wick, N.J.; CDL:095193-E)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Asulam Standard
MRID CITATION
00044583 Macey, P.A. (1975) Herbicides: Asulam: Metabolsism studies with
Asulam-Ring 14C on Alfalfa: Report No. RES/2402. (Unpublished
study received Dec 17, 1975 under 6F1716; prepared by May & Bak-
er, Ltd., England, submitted by Rhodia, Inc., New Brunswick,
N.J.; CDL:095193-G)
00044584 Guardigli, A. (1975) Procedures for the Measurement of Total Asu-
lam, Sulfanilamide and Acetylasulam in/on Forages, Fibers and
Mill-Processed Flax Seed Fractions by Colorimetry and Thin-Layer
Chromatography. Method no. 133 dated Aug 1975. (Unpublished
study received Dec 17', 1975 under 6F1716; submitted by Rhodia1,
Inc., New Brunswick, N.J.; CDL:095193-H)
00052047 Craine', E.M.; Ray, W.H.; Stevens!, K.R. (1972) Residues in the Milk
and Tissues of Dairy Cows Fed Asulam: Research Report No. EMC
72:27. (Unpublished study including report no. KRS 72:21, re-
ceived Dec 17, 1975 under 6F1717; prepared by Hess & Clark,
submitted by Rhodia!, Inc., New Brunswick, N.J.; CDL:095192-F)
000056417 Ingham, B. (1971) Herbicides: Asulox 40: Acute Oral Toxicity in
Mallard, Partridges, Pheasants and Pigeons: Report No. RG/11
(Unpublished study received June 11, 1972 under 2G1200; prepa-
red by May and Baker, Ltd., England', submitted by Rhodia', Inc.,
New Brunswick, N.J.; CDL:091017-T)
00056418 Heywood, B.A.; Ingham', B. (1970) Asulox: Subacute (5 Day) Toxicity
in Mallard Ducklings: Report No. RG/857. (Unpublished study.
received Jun 11, 1972 under 2G1200; prepared by May and Baker,
Ltd., England, submitted by Rhodia, Inc., New Brunswick, N.J.;
CDL:091017-U)
00056419 Heywood', B.A.; Ingham, B. (1970) Asulox: Subacute (5 Day) Toxicity
Study in Pheasant Chicks: Report No. RG/867. (Unpublished study
received Jun 11, 1972 under 2G1200; prepared by May and Baker,
Ltd., England, submitted by Rhodia, Inc., New Brunswick1, N.J.;
CDL:091017-V)
00056421 Fraser, W.D.; Jenkins', G. (1970) The Acute Toxicity of Asulam to
Rainbow Trout, Goldfish, Channel Catfish and Bluegill: Report
No. 3639/70/451. (Unpublished study received Jun 11, 1972 under
2G1200; prepared by Huntingdon Research Centre, England', sub-
mitted by Rhodia, Inc., New Brunswick', N.J.; CDL:091017-X)
00056422 Lira, L. (1968) Herbicides: Studies with 35S-M&B 9057 (Asulam)
in a Lactating Cow: PRG/73. (Unpublished study received Jun 11,
1972 under 2G1200; prepared by May & Baker, Ltd., England1, sub-
mitted by Rhodia, Inc., New Brunswick, N.J.; CDL:091017-Y)
102
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Asulam Standard
MRID CITATION
00056424 Mulcocki, P.A. (1971) Asulam: Decline Studies on Sugar-Cane with
Asulam-Ring 14C: RG/1002. (Unpublished study received Jun
11, 1972 under 2G1200; prepared by May & Baker1, Ltd., England',
submitted by Rhodia, Inc., New Brunswick, N.J.; CDL:091017-AA)
00056425 Mulcock', P.A. (1971) Asulam: Metabolic Pathways and Products in
Sugar Cane: RG/1109. (Unpublished study received Jun 11, 1972
under 2G1200; prepared by May & Baker, Ltd. England, submitted
by Rhodia, Inc., New Brunswick, N.J.; CDL:091017-AB)
00056432 Brockelsby, C.H.; Crouch', R.V.; Marshall', R.F. (1971) Asulam: An-
alytical Method for Residues in Raw Sugar Products (Syrup and
Molasses): RG/1159. Method dated Sep 1971. (Unpublished study
received Jun 14, 1972 under 2G1200; prepared by May & Baker',
Ltd., England), submitted by Rhodia, Inc., New Brunswick', N.J.;
CDL:091018-C)
00056435 Brockelsby', C.H. (1969) Asulam: Analytical Method for Residues in
Plant Material.: Report No. PRG.479. Method dated Jun 1969.
(Unpublished study received Jun 14, 1972 under 2G1200; prepared
by May & Baker, Ltd., England, submitted by Rhodia, Inc., New
Brunswick', N.J.; CDL:091018-F)
00056436 Brockelsby, C.H. (1971) Asulam (M&B 9057): An Improved Analytical
Method for Asulam in Plant Material with Particular Reference
to Sugar Cane: RG/969. Method dated Feb 1971. (Unpublished
study received Jun 14, 1972 under 2G1200; prepared by May &
Baker, Ltd., England', submitted by Rhodia, Inc., New Brunswick',
N.J.; CDL:091018-G)
00056438 Brockelsby, C.H. (1971) Asulam: An Analytical Method for Residues
in Sugar Cane: RG/1096. Method dated Jun 1971. (Unpublished
study received Jun 14, 1972 under 2G1200; prepared by May &
Baker, Ltd., England', submitted by Rhodia, Inc., New Brunswick',
N.J.; CDL:091018-I)
00056439 Brockelsby, C.H.; Crouchi, R.V.; Marshall, R.F. (1971) Asulam: An-
alytical Method for Residues in Raw Sugar Products (Dilute
Juice', Clarified Juice, Filtered Sludge): RG/1097. Method dated
Jul 1971. (Unpublished study received Jun 14, 1972 under
2G1200; prepared by May & Baker1, Ltd., England', submitted by
Rhodia, Inc., New Brunswick, N.J.; CDL:091018-J)
00056440 Brockelsby, C.H.; Crouch', R.V.; Marshall', R.F. (1971) Asulam: An-
alytical Method for Residues in Raw Sugar: RG/1098. Method
dated Jul 1971. (Unpublished study received Jun 14, 1972 under
2G1200; prepared by May & Baker, Ltd., England, submitted by
Rhodia, Inc., New Brunswick!, N.J.; CDL:091018-K)
103
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Asulam Standard
MRID CITATION
00056441 Rhodia', Incorporated (1971) Summary of Residue Data. (Reports by
various sources; unpublished study received Jun 14, 1972 under
2G1200; CDL:091018-L)
00056442 Brockelsby, C.H. (1971) Asulam (M&B 9057): Decline Studies on Sugar
Cane: RG.975. Procedure dated Feb 1971. (Unpublished study
received Jun 14, 1972 under 2G1200; prepared by May & Baker,
Ltd., England, submitted by Rhodia, Inc., New Brunswick, N.J.;
CDL:091018-M)
00082250 Hastings), S.E.; Huffman, K.W. (1975) Dominant Lethal Study of
Asulam in Mice: Report No. SEH 75:94. (Unpublished study re-
ceived Dec 17, 1975 under 6F1717; submitted by Rhodia, Inc.,
New Brunswick, N.J.; CDL:098085-E)
00084790 Rhodia1, Incorporated (1972) Summary: Safety of Asulam—Sugarcane.
Summary of studies 094626-C through 094626-S. (Unpublished
study received Nov 81, 1972 under 3F1331; CDL:094626-A)
00084804 Crouch, R.V.; Pullin, E.M. (1968) Asulam: Analytical Method for
Residues in Milk Report No. PRG.223. Method dated Jul 1968.
(Unpublished study received Nov 8, 1972 under 3F1331; prepared
by May & Baker', Ltd., England', submitted by Rhodia', Inc., New
Brunswick, N.J.; CDL:094626-Q)
00084805 Stevens, K.R.; Johnson, C.A.; Huffmani, K.W. (1972) The Biological
Effects of Feeding Asulam to Dairy Cows: Report No. KRS 72:21.
(Unpublished study received Nov 8^ 1972 under 3F1331; prepared
by Hess & Clark', submitted by Rhodia, Inc., New Brunswick1, N.J.;
CDL:094626-R)
00098505 Vilkasv A.G.; Kuc, W.J. (1979) The Acute Toxicity of Asulam Tech-
nical to the Bluegill Sunfish Lepomis macrochirus Rafinesque:
UCES Project No. 11506-48-06. (Unpublished study received Apr
16, 1982 under 359-662; prepared by Union Carbide Corp.', submit-
ted by Rhone-Poulenc Chemical Co., Monmouth Junction1, N.J.;
CDL:070772-A)
00098508 Vilkasi A.G.; Schneider', C.E. (1979) The Acute Toxicity of Asulam
Technical to the Grass Shrimp,: Palaemonetes pugio: UCES Proj-
ect No. 11506-48-05. (Unpublished study received Apr 16, 1982
under 359-662; prepared by Union Carbide Corp., submitted by
Rhone-Poulenc Chemical Co., Monmouth Junction', N.J.; CDL:
070772-D)
104
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Asulam Standard
MID CITATION
00098509 Schneider, C. (1979) The Acute Toxicity of Asulam Technical to
the Fiddler Crab Uca pugilator: UCES Project No. 11506-48-04.
(Unpublished study received Apr 16, 1982 under 359-662; prepared
by Union Carbide Corp.', submitted by Rhone-Poulenc Chemical
Co., Monmouth Junction1, N.J.; CDL:070772-E)
00098525 Cooper, I.C.; Unsworth, J.B. (1981) Asulam: Leaching Study with
Four Soils: AG.Tech. 19. (Unpublished study received Apr 16,
1982 under 359-662; prepared by May & Baker, Ltd., England,
submitted by Rhone-Poulenc Chemical Co., Monmouth Junction^
N.J.; CDL:070773-N)
00098534 Ward, R.J. (1981) Asulam (Technical Grade): Primary Eye Irrita-
tion Study in the Rabbit: Report Ref. R.Tox.57. (Unpublished
study received Apr 16', 1982 under 359-662; prepared by May &
Baker, Ltd., England1, submitted by Rhone-Poulenc Chemical Co.1,
Monmouth Junction', N.J.; CDL:070776-D)
00098535 Dale, E.A.; Grimmett, J.E. (1977) Asulam: Tests for Primary Skin
Irritation in Rabbits and Skin Sensitization in Guinea Pigs:
RES/2853. (Unpublished study received Apr 16, 1982 under 359-
662; prepared by May & Baker', Ltd., England, submitted by
Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:
070776-E)
00098536 Dale', E.A.; Ingham', B.; Woolf, N.; et al. (1979) Asulam: Six Month
Oral Toxicity Study in Beagles: Report Ref. RES 3699. (Unpub-
lished study received Apr 16', 1982 under 359-662; prepared by
May & Baker, Ltd., England!, submitted by Rhone-Poulenc Chemical
Co., Monmouth Junction!, N.J.; CDL:070776-F)
00098538 Copping, G.P. (1981) Asulam: Teratogenicity Study by the Oral
Route in the Rat: Report Ref. R. Tox. 11. (Unpublished study
received Apr 16, 1982 under 359-662; prepared by May & Baker',
Ltd., Englandi, submitted by Rhone-Poulenc Chemical Co., Mon-
mouth Junction!, N.J.; CDL:070776-H)
00098539 Copping, G.P. (1981) Asulam: Teratogenicity Study by the Oral
Route in the Rabbit: Report Ref. R.Tox. 37. (Unpublished study
received Apr 16, 1982 under 359-662; prepared by May & Baker i,
Ltd., England', submitted by Rhone-Poulenc Chemical Co., Mon-
mouth Junction', N.J.; CDL:070776-I)
105
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
. Registrations Under the Asulam Standard
MRID CITATION
00098540 Brentnall, D.W.; Woolf, N. (1981) Asulam: Two Generation Repro-
duction Study in the Rat: Report Ref. R.Tox. 34. (Unpublished
study received Apr 16, 1982 under 359-662; prepared by May &
Baker, Ltd., England', submitted by Rhone-Poulenc Chemical Co.,
Monmouth Junction', N.J.; CDL:070776-J)
00098542 Thilagar, A.; Knight, R.; Reichard, G.; et al. (1979) An Eval-
uation of Carcinogenic Potential of Asulam Employing the C3H/
10T1/2 Cell Transformation Assay: Study No. 596-249-8. (Un-
published study received Apr 16, 1982 under 359-662; prepared
by EG & G Masdn Research Institute(, submitted by Rhone-Poulenc
Chemical Co., Monmouth Junction1, N.J.; CDL:070776-L)
00098543 Hunter, B.; Barnard, A.V.; Street, A.E.; et al. (1981) Asulam: Tox-
icity and Tumorigenicity in Prolonged Dietary Administration to
Rats: HRC Report No. M & B 95/80554. Final rept. (Unpublished
study received Apr 16, 1982 under 359-662; prepared by Hunting-
don Research Centre, England', submitted by Rhone-Poulenc Chem-
ical Co., Monmouth Junction^ N.J.; CDL:070777-A)
00098545 Rhone-Poulenc Chemical Company (1981?) Plant Metabolism Studies
with Asulam. (Unpublished study received Apr 16, 1982 under
359-662; CDL:070778-B)
00098547 Somma', N. (1981) Asulam 14C-Analytical Plant Method Validation:
PDD No. 81/018. (Unpublished study received Apr 16, 1982 under
359-662; submitted by Rhone-Poulenc Chemical Co., Monmouth Junc-
tion, N.J.; CDL:070779-B)
00098548 Wargo, J.P.; Somma, N.; Piznik, M.; et al. (1981) A Common Moiety
Method for the Measurement of Asulam and Its Principal Metabo-
lites in Plant Substrates by High Performance Liquid Chroma-
tography: PDD No. 81/015. (Unpublished study received Apr 16,
1982 under 359-662; submitted by Rhone-Poulenc Chemical Co.,
Monmouth Junction, N.J.; CDL:070779-C)
00098549 Guytoni, C.L.; Pizniki, M.; Chowl, W.; et al. (1981) Total Asulam Res-
idues in/on Foliage and Hay Samples of Alfalfa: PDD No. 81/019.
(Unpublished study received Apr 16, 1982 under 359-662; sub-
mitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.;
CDL:070779-D)
106
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Asulam Standard
MRID CITATION
00098550 Guytoni, C.L.; Pizniki, M. (1982) A Comparison of Asulam Plant Res-
idue in/on Samples Analyzed by Analytical Method No. 133 and
Method No. 156: PDD No. 82/026. (Unpublished study received
Apr 16, 1982 under 359-662; submitted by Rhone-Poulenc Chemical
Co., Monmouth Junction1, N.J.; CDL:070779-E)
00098551 Mulkey, N.S.; Herrera, R.E. (1981) Determination of lAC-Residues
following Oral Administration of 141-Asulam to a Lactating
Goat: ADC Project #517. (Unpublished study received Apr 16',
1982 under 359-662; prepared by Analytical Development Corp.,
submitted by Rhone-Poulenc Chemical Co., Monmouth Junction,
N.J.; CDL:070780-A)
00098552 Mulkey, N.S.; Brown', D. (1981) Validation by Radiometric and Con-
ventional Means of Method No. 154i, a Common Moiety Method for
the Measurement of Asulam and Its Principal Metabolites in Ani-
mal Biological Substrates by High Performance Liquid Chroma-
tography: ADC Project No. 517-B. Rev. (Unpublished study re-
ceived Apr 16, 1982 under 359-662; prepared by Analytical De-
velopment Corp. j. submitted by Rhone-Poulenc Chemical Co., Mon-
mouth Junction, N.J.; CDL:070780-B)
00098553 Rhone-Poulenc Chemical Company (1981) Residue Studies of Asulam
Found in Milk and Tissue of Dairy Animals. Rev. (Compilation;
unpublished study received Apr 16, 1982 under 359-662; CDL:
070780-C)
00113827 Rhodia, Inc. (1973) The Results of Tests on the Amount of Residue
Remaining', Including a Description of the Analytical Method
Usedi, of the Pesticide Chemical: Asulam. (Compilation; unpub-
lished study received on unknown date under 3F1331; CDL:
093562-B)
000113828 Mayceyi, P. (1975) Asulam Residue Studies with Asulam-ring 14C on
Sugar Cane: RG/2158. (Unpublished study received Feb 5, 1975
under 3F1331; prepared by MAy & Baker', Ltd., Eng., submitted by
Rhodiai, Inc., New Brunswick, NJ; CDL:093563-A)
00113830 Brockelsby, C. (1975) Asulam Residue Studies on Sugar Cane: RG/
2164. (Unpublished study received Feb 5, 1975 under 3F1331;
prepared by May & Baker', Ltd., Eng., submitted by Rhodiai, Inc.,
New Brunswick, NJ; CDL:093563-C)
107
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY .
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Asulam Standard
MRID CITATION
00113831 Rhodia, Inc. (1973) Study: Asulam Residue on Sugarcane. (Compi-
lation; unpublished study received on unknown date under 3F1331;
CDL:094623-A)
00113833 Stevens; K. (1971) Letter sent to C. Johnson dated Dec 27!, 1971:
Asulam—Working protocol. (Unpublished study received on un-
known date under 2G1200; submitted by Rhodia1, Inc., New Bruns-
wick, NJ; CDL:097980-A)
00113836 Rhodia', Inc. (1972) Residues of Asulam in Sugarcane. (Compila-
tion; unpublished study received on unknown date under 2G1200;
CDL:097985-A)
00113837 Rhone-Poulenc1, Inc. (1971) Study: Asulam Residue on Sugarcane.
(Compilation; unpublished study received Jul 19, 1971 under un-
known admin, no.; CDL:120793-A)
00136346 Brockelsby, C.; Crouch, R.; Marshall, R. (1971) Asulam: Residue
Studies on Sugar Cane. (Unpublished study received 1971 under
2G1200; prepared by May & Baker Ltd., Eng.i, submitted by Flora-
synth, Inc., New Yorkl, NY; CDL:097986-A)
108
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APPENDIX V
FORMS
109
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OMB Approval Ho. 2000-0468
FIFHA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposed by the FIFRA section 3(CM2MB) notice contained in the referenced
Guidance Document, I am responding in the following manner:
1. I will submit data in a timely manner to satisfy the following requirements.'If the tin procedures I will us* deviate from (or are not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, OECD
Chemicals Testing Programme, I enclose the protocols that I will use:
D 2. I have entered into an agreement with ont or more other registrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
D 3. I melon i completed "Certification of Attempt to Entir Into an Agreement with Other Registrants for Development of Data" with
respect to the following data requirements:
. I raquan that you amend my registration by delating the following uses (this option is not available to applicants for new products):
D 5. I rtqunt voluntary cancellation of tha registration of this product (This option it not available to applicant! for new products.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
tPA Pom MM-1 (10*2)
MO
-------
OMB Approval No. 20OOO468
(To qualify, certify ALL four items)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly authorized to represent the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME OF FIRM
EPA COMPANY NUMBER
(This firm or group of firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
My firm hat offered in writing to inter into such in agreement Copies of tht often are attached. That offer was irrevocable and included an offer to be
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. This offer was made
to the following firm(s) on the following dated):
NAME OF FIRM
DATE OF OFFER
However, none of those firm(s) accepted mv 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 whethor 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
EPA Form 86604 (10-62)
SIGNATURE
DATE
111
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PRODUCT SPECIFIC DATA REPORT
EPA Reg. No.
Date
Guidance Document for
Registration
Guideline No.
§158.120
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Test
Identity of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification
of limits
Analytical
methos for en-
force 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 my
product
listed
above
(check
below)
-
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA
Use Only)
MRID Numbers
Assigned
112
-------
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
8.1-6
Name of Test
Stability
Oxid i z ing/ reduc-
ing reaction
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral
toxicity, rat
Acute dermal
toxicity, rabbit
Acute inhalation,
toxicity, rat
Primary eye irri-
tation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA
Use Only)
MRID Numbers
Assigned
113
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,0MB Approval No."2070-0057
'Expiration Date 11/30/89
"GENERIC" DATA EXEMPTION STATEMENT
EPA Product Registration Number:
Registrant's Name and Address:
As an authorized representative of the registrant of the product identified
above, I certify that:
(1) I have read and am familiar with the terms of the Notice from EPA dated
concerning a requirement for submission of "generic" data on the
active ingredient named under FIFRA Section 3(c)(2)(B).
(2) My firm requests that EPA not suspend the registration of our product,
despite our lack of intent to submit the generic data in question, on the grounds
that the product contains the active ingredient solely as the result of the
incorporation into the product of another product which contains that active
ingredient, which is registered under FIFRA Ssrtion 3, and which is purchased by
us from another producer.
(3) An accurate Confidental Statement of Formula(CSF) for the above-identified
product is attached to this statement. That formula statement indicates, by
company name, registration number, and product name, the source of the subject
active ingredient in my firm's product, or
The CSF dated on file with EPA is complete, current and accurate and
contains the information requested on the current CSF Form No. 8570-4. The
registered source(s) of the above named active ingredient in my product(s) is/are
and their registration number(s) is/are .
My firm will apply for an amendment to the registration prior to changing
the source of the active ingredient in our product.
(4) I understand, and agree on behalf of my firm, that if at any time any
portion of this Statement is no longer true, or if my firm fails to comply with
the undertakings made in this Statement, my firm's product's registration may be
suspended under FIFRA Section 3(c)(2)(B).
(5) I further understand that if my firm is granted a generic data exemption
for the product, my firm relies on the efforts of other persons to provide the
Agency with the required generic data. If the registrant(s) Who have committed
to generate and submit the required data fail to take appropriate steps to meet
requirements or are no longer in compliance with this Notice's data requirements,
the Agency will consider that both they and my firm are not in compliance and
will normally initiate proceedings to suspend the registrations of my firm's
product(s) and their product(s), unless ray firm commits to submit and submits
the required data in the specified time frame. I understand that, in such cases,
the Agency generally will not grant a time extension for submitting the data.
Registrant's authorized representative:
(Signature)
Dated:
ERA Form 8570-27
I I T1
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