Unitad Statat
«>EPA
Protacttof!
AgMiey
Of. icn e-f
Pwticidw and Toxic Sutaataneat
Washington OC 20460
June 1986
PwictdM
Guidance for the
Reregistration of
Pesticide Products
Containing Glyphosate
as the Active Ingredient
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GUIDANCE FOR THE REREGISTRATION
OF PESTICIDE PRODUCTS CONTAINING
GLYPHOSATE
AS THE ACTIVE INGREDIENT
CASE NUMBER 0178
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
JUNE 1986
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TABLE OF CONTENTS
I. Introduction
II. Chemicals Covered By This Standard
A. Description of Chemical
B. Use Profile
III. Agency Assessment ->
A. Summary Science Statement
B. Toxicology Characteristics
C. Physiolofical and Biochemical Behavior
Characteristics
D. Environmental Characteristics
E. Ecological Characteristics
F. Tolerance Reassessment
IV Regulatory Position And Rationale , 20
A. Regulatory Position and Rationale
B. Criteria For Registration
C. Acceptance Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard 35
VI. Requirement for Submission of Generic Data 3
A. What are Generic Data ?
B. Who must submit generic data ?
C. What generic data must be submitted ?
D. How to comply with DCI'requirements
E. Procedures for requesting a change in protocol
F. Procedures for requesting extensions of time
G. Existing stocks provisions upon suspension or
cancellation I
VII. Requirement for Submission of Product Specific Data . 42
VIII. Requirement for Submission of Revised Labeling 43
IX. Instructions for Submission 44
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End,Tuse products
D. Intr.astate products
E. 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
Guide to Bibliography
\
Bibliography
V. FORMS APPENDICES
EPA Form 8580-1 FIFRA §3(c)(2)(B) Summary Sheet
EPA Form 8580-6 Certification of Attempt to Enter Into an
Agreement with Other Registrants for Development
of Data
EPA Form 8580- Product Specific Data Report (End-Use Products)
EPA Form 8580- Formulator's Exemption Statement
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I. INTRODUCTION
The Registration Standards Program
EPA has established the Registration Standards program
in order to provide an orderly mechanism by which pesticide
products containing the same active ingredient can be reviewed
and standards set for compliance with FIFRA. The standards
are applicable to reregistration and future applications for
registration of products containing the same active ingredient.
Each registrant of a product containing an active ingredient
subject to this Standard who wishes to continue to sell or
distribute that product must bring his product and labeling
into compliance with FIFRA, as instructed by this Standard.
Pesticides have been grouped into use clusters and will be
reviewed on the basis of a ranking scheme giving higher
priority to (1) pesticides in clusters used on food and feed
crops; and (2) pesticides produced in large volumes.
The Registration Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA. In its 'review EPA identifies
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the
pesticide.
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
iThe scientific reviews may be purchased from the National
Technical Information Service, 5285 Port Royal Road, Springfield
Virginia 22161 approximately 90 days after issuance.
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active ingredient. However, during the review of these data
the Agency is also looking for potential hazards that may be
associated with the end use products that contain the active
ingredient. The Agency will apply the provisions of this
Registration Standard to end use products if necessary to
protect man and the environment.
EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard,
on the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory position, the Agency may prescribe a variety of
steps to be taken by registrants to maintain their registrations
in compliance with FIFRA. These steps may include:
1. Submission of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide, to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154
to examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency
may propose additional regulatory actions, such as proposed
cancellation of uses of the pesticide which have been determined
to cause unreasonable adverse effects on the environment.
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EPA has authority under the Data Call-in (DCI) provisions
of FIFRA sec. 3(c)(2)(B) to require that registrants submit
data to answer our questions regarding the chemical, toxicological,
and environmental characteristics and fate of a pesticide.
This Registration Standard lists the data EPA believes are
necessary to resolve our concerns about this pesticide.
These data are listed in Section V - Requirement for Submission
of Generic Data, and Section VI - Requirement for Submission
of Product-Specific data. Failure to comply with the DCI
requirements enumerated in this Registration Standard may
result in issuance by EPA of a Notice of Intent to Suspend
the affected product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any time that they
become aware of such information. You should notify the
Agency of any information, including interim or preliminary
results of studies, if those results suggest possible adverse
effects on man or the environment. This requirement continues
as long as your products are registered by the Agency.
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11• CHEMICALS COVERED BY THIS STANDARD
A- Description of Chemicals
The following chemicals are covered by this Registration
Standard:
Common name: isopropylamine salt (IPA) of glyphosate
Chemical name: isopropylamine salt of N-(phosphonomethyl)
glycine
CAS Number: 38641-94-0
OPP Shaughnessy Number: 103601
Empirical Formula: C3HgNO5P
Trade Names: Roundup; Rodeo, Roundup L&G, Shackle, Shackle C
Description of chemical characteristics: White crystalline
solid with a melting point of 200 °C with a bulk density
of 1.74. This chemical is 1 percent soluble in water
at 25 °C; insoluble in ethanol, acetone, or benzene.
Common name: sodium salt of glyphosate
Chemical name: sodium salt of N-(phosphonomethyl) glycine
CAS Number: 38641-94-0
OPP Shaughnessy Number: 103603
Trade Names: Polado
Description of chemical characteristics: White crystalline
solid which decomposes at 140 °C with a bulk density of 30
pounds per cubic foot (lb/ft3). This chemical is soluble
in water and insoluble in organic solvents.
B. Use Profile
Type of pesticide: IPA salt herbicide
Sodium salt - plant growth regulator
Pests controlled: Grasses, sedges, and broadleaf weeds
(annual and perennial)
Registered Uses: IPA salt (terrestrial food, nonfood
crop, and noncrop; aquatic food and noncrop; greenhouse
nonfood, domestic outdoor, and forestry); sodium salt
(terrestrial food crop).
Predominant Uses:
IPA salt of glyphosate: soybeans, cotton, corn,
sorghum, wheat, rice, vegetables, citrus fruits,
pome fruits, stone fruits, tropical fruits, pastures,
and alfalfa.
Sodium salt of glyphosate: sugarcane.
Mode of activity: Inhibition of amino acid synthesis.
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Formulation Types Registered: 1.04 Ib active ingredient
(ai)/gal emulsifiable concentrate (EC); 0.42, 3, and
4 Ib ai/gal soluble concentrate/liquid (SC/L); 5% and
6.6% ai SC/L; 0.5%, 0.96%, and 1% ai liquid ready to
use (RTU); and 0.75% and. 0.96% ai pressurized liquid
(Prl).
Methods of Application: Foliarly, in broadcast application,
using conventional ground equipment, handheld, recircu-
1ating, and shielded sprayers, wiper applicators and
aerial application.
III. AGENCY ASSESSMENT
Summary Science Statement
Glyphosate has low acute toxicity (Category III) for
acute oral, acute dermal, and primary eye irritation and
is in Category IV for primary skin irritation. It is
not teratogenic to rats or rabbits and is not mutagenic.
The oncogenic potential is not fully defined at this
time. Repeat oncogenic studies are required in mice and
rats.
Glyphosate is no more than slightly toxic to birds,
aquatic invertebrates, and fish. It does pose a risk
to some endangered species.
Glyphosate is stable to hydrolysis and strongly adsorbed
onto the soil and has a low potential to contaminate
ground water.
Toxicology Characteristics
Acute Toxicity ,
Acute oral and dermal toxicity data place technical
glyphosate in Toxicity Category III. Primary eye and skin
irritation data indicate that technical glyphosate is not a
primary skin irritant (Toxicity Category IV), and is only
minimally irritating to the eye (Toxicity Category III). Acute
inhalation or dermal sensitization studies have not been
submitted and are required.
Chronic Feeding/Oncogenicity Data
Available chronic feeding/oncogenicity data include
chronic feeding/oncogenicity studies in mice and rats and
a 1-year chronic feeding study in dogs. A discussion of
these studies follows.
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The chronic feeding/oncogenicity study in mice tested
dosages of 1000, 5000, and 30,000 parts per million (ppm)•
Glyphosate produced an equivocal oncogenic response in the
mouse, causing a slight increase in the incidence of renal
tubular adenomas (a benign tumor of the kidney) in males at
the highest dose tested of 30,000 ppm. The Toxicology Branch
Ad Hoc Oncogenicity Committee tentatively classified glyphosate
as a "Class C" oncogen. The studies were reexamined by a
consulting pathologist, and data were submitted indicating
that an additional kidney tumor had been found in control males
(no renal tumors were found in controls in the original
examination). The Agency then requested that additional kidney
sections from the mouse study be prepared and examined. The
resultant microslides were examined by a number of pathologists.
These examinations revealed no additional tumors, but confirmed
the presence of the tumors identified in the original study
report. The apparent lesion in the control kidney was not
present in any of the additional sections. After examination
of the slides, the Agency concluded that this lesion did not
"represent a pathophysiologically significant change."
However the apparent oncogenic response was a marginal
response at best. The doses tested were quite high, 3 percent
of the diet, and there was no corresponding increase in the
incidence of preneoplastic changes, such as hyperplasia or
dysplasia, in the target tissue. Further, glyphosate is
negative in a number of acceptable mutagenicity studies,
therefore the compound is not known to be genotoxic.
/
Because of the equivocal nature of the findings, the
Toxicology Ad Hoc Oncogenicity Committee asked the expert
assistance of the FIFRA Science Advisory Panel (SAP) in
determining the proper Weight-of-the-Evidence classification
of the study. After reviewing all the available evidence,
the SAP proposed that glyphosate be classified as "Class D, "
or having "inadequate animal evidence of Oncogenicity."
The principal reason for this assessment by the SAP was their
determination that, after adjusting for the greater survival
in the high dose mice compared to concurrent controls, no
statistically significant difference existed. The SAP
further noted that, although comparison of these findings to
historical control incidences yielded a statistically
significant result, this finding did not over-ride the lack
of significance of comparisons to concurrent controls. The
SAP determined that the oncogenic potential of glyphosate
could not be determined from existing data and proposed that
the study be repeated in order to clarify these equivocal
findings.
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After consideration of the expert opinion of the SAP, and
reconsideration of all relevant data for this compound in
particular the statistical assessment provided by the SAP, the
Agency agrees that available data are not sufficient to
adequately address the question of whether the apparent
effects noted in the mouse study are biologically relevant.
Therefore, in order to fully address this question, the Agency
is requiring that this study be repeated with a larger number
of animals in each test group, so that the statistical power
of the study is increased.
Other non-neoplastic changes noted in high-dose male mice
included centrilobular hypertrophy and necrosis of hepatocytes,
chronic interstitial nephritis, and proximal tubule epithelial
cell basophilia and hypertrophy in females. The no-observable
effect level (NOEL) for non-neoplastic chronic effects was
the mid-dose level, 5000 ppm. This study is acceptable as a
chronic feeding study.
The lifetime feeding study in rats tested dietary
concentrations of glyphosate of 0, 30, 100, and 300 ppm.
These concentrations were adjusted during the course of the
study so that actual doses of 0, 3, 10, and 31 mg/kg/day
in males and 0, 3, 11, and 34 mg/kg/day in female rats were
maintained. Thus, the doses tested in the rat chronic study1
were about 1/100 of those tested in the mouse study. Although
no effect of treatment on the incidence of non-neoplastic
lesions was noted, a marginal apparent increase in the
incidence of interstitial cell tumors of the testes was
observed in the rats. Historical controls were used in the
Weight-of-the-Evidence analysis to provide an indication of
the range of variability in the background spontaneous incidence
of any lesion, and were used to supplement the data provided
by a concurrent control group. Because of the absence of a
dose-dependent effect, the lack of preneoplastic changes,
the wide variability in the spontaneous incidence of this
tumor, the similarity in incidences between the high dose
group and the historical controls, and lack of any evidence;
of genotoxicity, it was concluded that the observed incidence
did not demonstrate an oncogenic response. An independent
review of the data raised a question of possible thyroid
carcinoma in high-dose females. After a review of the slides
by a consulting pathologist, and a reassessment of all relevant
data, including the fact that no effect of treatment on tumor
latency or the combined incidences of adenoma and carcinoma
was apparent, the Agency concluded that the data did not
demonstrate a carcinogenic response in the thyroid.
However, in view of the large differency in doses between
the rat and mouse studies, the Toxicology Branch Oncogenicity
Review Committee speculated that ''a toxic, or MTD [Maximally
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Tolerated Dose], was not reached in [the rat] study," and
that at doses "close to an MTD, tumors might have been Induced."
The rat study was rereviewed for evidence that the highest
dose tested was an MTD. No effect of treatment on survival,
body weight gain, clinical pathology, or findings at necropsy
was noted. Therefore, there is no evidence that the highest
dose tested was an MTD. A repeat rat study is required in
which-the highest dose tested is an MTD. This study is
acceptable as a chronic feeding study, since an MTD is not
required to satisfy Agency guidelines for chronic toxicity
studies. Since an MTD was apparently not reached in this
study, it does not fulfill the Guideline (§158.135 83-2)
requirement for a rat oncogenicity study.
A 1-year chronic feeding study in dogs tested doses of
0, 20, 100, and 500 mg/kg/day, administered by capsule. The
only effect of treatment was an apparent decrease in the
absolute and relative weights of pituitaries from mid- and
high-dose dogs. Additional data have been requested to
better assess this apparent effect. The tentative NOEL is
20 mg/kg/day pending submission of requested data.
Subchronic Toxicity Studies
No acceptable rat or dog subchronic feeding studies are
available for technical glyphosate. IBT studies submitted
for both species were invalid.
A 3-month subchronic study in mice tested dietary
concentrations of 0, 5000, 10,000, and 50,000 ppm of
technical glyphosate. A decrease in body weight gain was
noted in high-dose mice; however, no gross or microscopic
changes were observed at necropsy. The study was classified
as Supplementary data because hematology, clinical chemistry,
an^. urinalysis measurements were not performed.
k
The 3-month subchronic study in mice does not have to be
repeated because the lifetime chronic feeding study in rats
discussed above fulfills the Guideline requirement (§158.135,
82-1) for a subchronic feeding study in a rodent. A 3-month
subchronic study in dogs is not required because the 1-year
chronic feeding study in dogs discussed above fulfills the
Guideline requirement (§158.135 82-1) for a subchronic feeding
study in a nonrodent.
A 21-day dermal toxicity study in rabbits testing dermal
doses of 100, 1000, and 5000 mg/kg/day for 5 days/week for
3 weeks has been submitted. The only effect noted was slight
edema and erythema of the skin at the high dose ^5000 mg/kg/day)
The no observable effect level (NOEL) for these effects was
1000 mg/kg/day. This study is acceptable. No additional
data are required.
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Teratology and Reproduction Studies
Acceptable teratology and reproduction studies have been
submitted. Therefore- no additional data are required for
these topics. A discussion of the acceptable data follows.
A teratology study in rats tested levels of 0, 300, 1000,
and 3500 mg/kg/day with no evidence of teratology observed
in the study. Evidence of developmental toxicity in the form
of unossified sternebrae was noted in fetuses from the high
dose (3500 mg/kg/day). This dose was also toxic to dams as
evidenced by weight gain deficits, altered physical appearance,
and mortality during treatment. The fetotoxic and maternal
toxic NOEL for this study is 1000 mg/kg/day.
A teratology study in rabbits tested dosage levels of 0,
75, 175, or 350 mg/kg/day with no evidence of teratogenicity
observed. The highest dose tested was toxic to does as
evidenced by altered physical appearance and mortality. No
treatment-related fetal effects were noted. The NOEL for
maternal toxicity is 175 mg/kg/day and the NOEL for feto-
toxiclty is 350 mg/kg/day.
»
In the three-generation rat reproduction study and
addendum, the most significant finding was focal, unilateral,
renal tubular dilation in the kidneys of male pups from the
F3b generation of high-dose dams (30 mg/kg/day). The NOEL
for this effect'was 10 mg/kg/day. No effects on fertility
or reproductive parameters were, noted.
Mutagenlcity
Acceptable studies have been submitted to satisfy the
Agency's testing requirements for gene mutations, chromosomal
aberrations, and primary DNA damage. Glyphosate was negative
for gene mutations in Chinese hamster ovary cells in the
presence or absence of microsomal activation. Glyphosate
was also negative for gene mutations in bacteria, with or
without activation. Glyphosate was negative for chromosomal
aberrations in the mouse dominant lethal test and in the ±n
vivo cytogenetics assay. No primary DNA effects were seen
with glyphosate in the B. subtilis rec assay or in the rat
hepatocyte DNA repair assay. No additional mutagenicity data
are required.
Neurotoxlcity
Even though glyphosate is not an organophosate or carbamate
pesticide, a delayed neurotoxicity study was conducted in
chickens at Industrial Bio-Test Laboratories. Although no
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evidence of neurotoxicity was noted in the study, the valida-
tion report for this study noted an absence of raw data for
dose preparation and administration, body weight measurements,
and pathological observations for untreated and positive
control birds. After evaluation of the study for scientific
content, the study was classified as invalid on the basis of
the extensive gaps in the raw data supporting study findings
and conclusions.
A repeat neurotoxicity study is not required because the
guidelines (§153.135 81-7) require this study only for organo-
phosphate or carbamate pesticides. Glyphosate is neither an
organophosphate nor a carbamate pesticide, therefore, the
study is not required.
Metabolism
Available metabolism data demonstrate that glyphosate is
rapidly excreted by rats, as > 90 percent of the administered
dose was eliminated within 48 hours of treatment. In males,
the majority of excretion was via the feces (80%), and about
15 percent of the administered dose was eliminated in the
urine. In females, about 40 percent of the administered dose
was excreted in the urine, which suggests that female rats
absorbed more glyphosate from the gastrointestinal tract than
did males.
After a single oral or intraperitoneal dose less than 1
percent of the administered dose was retained at 120 hours
after treatment. In animals fed 1, 10, or 100 ppm of 14C-
glyphosate for 14 days, a steady-state equilibrium between
intake and excretion of label was reached within about 8
days. The amount of radioactivity excreted in the urine
declined rapidly after withdrawal of treatment. By 10 days
after withdrawal, detectable levels of radioactivity were
measured in the urine and feces of only the rats fed 10 or
100 ppm of the test diet. Only minimal residues of 0.1 ppm,
or less remained in the tissues of high-dose rats after 10 "'
days of withdrawal, with no single tissue showing a signifi-
cant difference in the amount of label retained.
The submitted studies are deficient in that data for the
analysis of excreta for the presence of metabolites were not
submitted, and only one to three animals was used in each
experimental group. The submitted data demonstrated differen-
tial effects on excretion and retention of radioactivity
depending on the molecular location of the radioactive label.
These findings are strong evidence tht.t some metabolism of
glyphosate occurred in rats.
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These studies are not adequate to fulfill Guideline
requirements (§158.135 85-1), therefore repeat studies are
required.
N-Nitr'oso^Glyphosate
The Agency has determined that technical glyphosate
contains N-nitroso-glyphosate (NNG) as a contaminant at
levels of 0.1 ppm or less. The Agency has determined that
oncogenicity testing of nitroso contaminants will normally
be required only in those cases in which the level of nitroso
compounds exceeds 1.0 ppm (see "Pesticide Contaminated with
N-nitroso Compounds, proposed policy 45 PR 42854 (June 25,
1980)"). Therefore, although a chronic feeding study in
rats was reviewed and found unacceptable, no additional
studies are requested at this time.
Acute oral toxicity data for NNG place it in Toxicity
Category III. Other acute toxicity data for NNG are not
available.
Chronic toxicity studies on NNG in the dog and rat were
conducted at IBT. After a raw data audit, both studies were
Judged to be "supplementary" (not adequate to fulfill
guideline requirements). Both studies were then evaluated
for scientific acceptability, and the rat study was invalid
due to dosing of the control groups with an excessive amount
of NaCl which resulted in high mortality of control animals.
The dog study remained classified "supplementary" due to the
lack of supporting raw data as identified in the raw data audit
validation report. The only apparent treatment-related
findings in the dog study were an increase in absolute and
relative kidney weights and in blood glucose in high-dose
(30 mg/kg/day) females. The NOEL for this apparent effect
was 10 mg/kg/day.
A 90-day subchronic oral toxicity study with NNG was
conducted in the rat. The principal effect of treatment was
a dose-related decrease in survival, food consumption, and
body weight gain. A NOEL was not established in this study
since these effects were noted at the lowest dose tested,
3000 mg/kg/day. The study was classified as "supplementary"
data due to Inadequate reporting of clinical signs and necropsy
data, and inadequate identification of the test material.
A rat metabolism study conducted with NNG demonstrated
that NNG is rapidly absorbed and excreted, with the kidneys
the preferential route of elimination. These findings are in
direct contrast with the results of the metabolism studies
with glyphosate, which found that absorption from the gut
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was poor and the majority of excretion occurred in the feces
due to unabsorbed radiolabel. Tissue residues after five
consecutive doses were minimal, as no tissue contained more
than 1.5 ppm of radiolabel.
No acceptable studies for mutagenic.or reproductive
effects are available at present for NNG.
Because the amount of N-nitroglyphosate is less than 1.0
ppm no additional toxicology data are required; therefore,
none of the above studies are to be repeated or required.
Plant Metabolite—Aminomethylphosphonic Acid
The Agency has determined that the metabolite aminomethyl-
phosphonic acid (AMPA) is formed on plants in amounts that
can range as high as 28 percent of the total residue on the
plant. Since the extent of glyphosate metabolism was not
adequately addressed in the rat metabolism study, the possi-
bility exists that the AMPA metabolite could pose a hazard
to humans that was not evaluated by testing the parent com-
pound glyphosate. If an acceptable rat metabolism study
is submitted which demonstrates significant conversion of
glyphosate to AMPA in animals, additional studies on this
metabolite may be not necessary, since the toxicity of AMPA
will have been assessed by chronic feeding studies with the
parent compound glyphosate.
Acute oral toxicity and primary skin irritation data
place AMPA in Toxicity Category IV. The primary eye irrita-
tion study demonstrated that AMPA was slightly irritating to
the eye, corresponding to Toxicity Category III.
A 90-day subchronic feeding study was submitted that
demonstrated irritation of the urinary bladder in rats
treated with 1200 mg/kg/day, the lowest effect level (LEL) •
in this study. This irritation was manifested in the form '
of hyperplasia of the cells lining the bladder, and was
noted with increased incidence and severity at the highest
dose tested, 4800 mg/kg/day. Epithelial hyperplasia of the
renal pelvis was also noted in high-dose rats. The NOEL for
this effect was 400 mg/kg/day, and the study was classified
as Core-Minimum.
A rat metabolism study demonstrated that AMPA is rapidly
excreted as the parent compound. No evidence for bioaccumula-
tion was noted in this study, which was classified as Supple-
mentary data because the number of animals studied was not
reported, only males were studied, and the effects of a
minimally toxic dose and repeated nontoxic doses on excretion
metabolism, and accumulation were not assessed. '
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The limited data available for AMPA do not suggest that
this compound poses any hazard distinct from that of the
parent compound. No studies are available by which to assess
potential mutagenic, reproductive, oncogenic, or chronic
effects of AMPA. The need Tor additional testing of this
compound will be assessed after the submission of an accept-
able rat metabolism study with glyphosate.
Physiological and Biochemical Behavior Characteristics
Foliarly applied glyphosate is readily absorbed and
translocated from treated areas to untreated shoot regions
and fruits of grapes, apples, pears, dwarf citrus, and coffee,
and to untreated shoots and roots of seedling almond, pecan,
and walnut. _ __
The mechanism of pesticidal action for glyphosate is
believed to be inhibition of amino acid biosynthesis resulting
in a reduction of protein synthesis and Inhibition of growth.
The metabolism of glyphosate occurs via N-methylation and
ultimately yields N-methylated glycines and phosphonic acids.
In plants, degradation of [^C] glyphosate to ^CO^ and the
subsequent photofixation of respired l^CC^ was evidenced by
presence of l^C-residues in control plants housed in close
proximity to treated plants. The parent compound and its
metabolite AMPA are considered to be the residues of concern
in plants. No additional plant metabolism data are required.
In animal feeding studies using nonradiolabeled glyphosate
and AMPA in a 3:1 ratio, glyphosate was detected in the liver
of poultry, swine, and cattle and the kidney of swine and
cattle; AMPA was detected in liver of poultry, swine, and
cattle and in the kidney of swine and cattle. Residues of
the parent glyphosate and AMPA have also been identified in
the tissues, urine, and feces of rats and rabbits. Additional
metabolism studies with ruminants and poultry are required.'
Environmental Characteristics
Glyphosate and its degradate aminomethylphosphonic acid
are stable to hydrolysis in sterile, buffered water at pH 3,
6, and 9. In three natural waters (pH 4.2, 6.2, and 7.2)
glyphosate degraded with half-lives of < 50, 63, and > 35
days, respectively. Addition of sediment to the three natural
water systems increased the rate of dissipation of glyphosate
from water via sorption to sediment. Glyphosate dissipated
in pondwater with a half-life of between 14 and 21 days. In
two canal waters, glyphosate' was not detected 6 months
posttreatment. Glyphosate and aminomethylphosphonic acid
dissipation rates and concentrations in treated forest soils
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are extremely variable ranging from < 0.002 ppm in stream-water
samples to 89 ppm in foliage samples. Based on the available
data that indicate that glyphosate is strongly adsorbed to
the soil, the potential of glyphosate to contaminate ground-
water is expected to be low. Glyphosate has the potential to
contaminate surface waters because of application to aquatic
sites. Glyphosate residues have a low potential to bio-
accumulate in fish or clams.
Only the hydrolysis study is acceptable to fulfill
Guideline requirements. The following data are required to
fully assess the environmental fate of glyphosate: photo-
degradation studies in water, on soil, and in air; aerobic
and anaerobic soil metabolism studies; aerobic and anaerobic
aquatic metabolism studies; adsorption and desorption studies;
laboratory volatility studies; terrestrial, forestry, and
aquatic field dissipation studies; and accumulation studies
on rotational, irrigated crops and fish. Additional data may
be required if requested studies indicate the need for addi-
tional data. '
Exposure
The primary potential for exposure from the soluble
concentrate/liquid (SC/L) formulation is during mixing and
loading where both dermal and ocular exposure via splashing
may occur. Inhalation and dermal exposure may occur during
application of liquid ready to use (RTU) and pressurized
liquid (Prl) formulations. Application from aircraft increases
the potential "exposure of humans and nontarget organisms to
glyphosate due to spray drift and volatilization.
The California Department of Food and Agricultural reported
that glyphosate ranked third in the number of illnesses reported
from exposure to pesticides. The majority of these illnesses
were associated with skin and eye irritation during mixing,
loading and application of glyphosate. Although technical ,
glyphosate has very low toxicity (Toxicity Category III or 'IV)
the formulated products for agricultural use cause moderate
eye irritation (Toxicity Category II) and some dermal irritation
(Toxicity Category III). To reduce the risk of injury to skin
and eyes from use of glyphosate the Agency is requiring that
"Worker Safety Rules" requiring protective clothing appear on
all formulated products labeled for agricultural or aquatic use.
The end-use products registered for homeowner use are of
very low concentration (0.1 to 10% active ingredient) and
have very low acute toxicity (Category III and IV); therefore
the Agency will not require protective clothing for these
products.
14-
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Available acute dermal toxicity data place technical
glyphosate and its formulated products for agricultural use in
Toxicity Category III. Because of the low toxicity of gly-
phosate materials as applied, the Agency believes that there
is no risk of acute injury to field workers from applications
of glyphosate. Therefore reentry data will not be required
by the Agency.
Ecological Characteristics
Terrestrial Organisms
Based on an acute oral toxicity of > 2000 mg/kg/day for
bobwhite quail, glyphosate is no more than slightly toxic to
bobwhite quail on an acute oral basis. Available data indi-
cate that the 3-day dietary toxicity of glyphosate is > 4000
ppm for both mallard ducks and bobwhite quail. Based on the
forgoing data, the Agency has determined that glyphosate is
no more than slightly toxic to birds. Avian reproduction
studies indicate reproductive impairment would not be expected
at dietary levels up to 1000 ppm. Glyphosate is relatively
nontoxic to honeybees. Available data indicate that the 48-
hour acute toxicity to honeybees is > 100 micrograms per bee.
Aquatic Organisms
Based on a 48-hour acute toxicity of 780 ppm for Daphnia
magna, technical glyphosate is no more than slightly toxic
to aquatic invertebrates. Three tests on warmwater species,
one bluegill and two fathead minnow, produced the 96-hour
toxicities of 120 ppm, 84 mg/L and 97 mg/L, respectively;
two rainbow trout 96-hour toxicities of 86 mg/L and 140 mg/L.
These data indicate that glyphosate is no more than slightly
toxic to freshwater species.
In addition to the acute studies a fish lifecycle study
showed no effects at 25.7 mg/L, the highest level tested, ,
indicating that glyphosate has a maximum acceptable threshold
concentration (MATC) greater than 25.7 mg/L. A Daphnia study
with MATC between 50 and 96 mg/L reported reduced reproductive
capacity, the most sensitive parameter.
A series of studies was performed on marine/estuarine
species. A 96-hour toxicity of 281 mg/L was found for grass
shrimp. In a study on fiddler crabs, it was determined that
96-hour toxicity is 934 mg/L glyphosate. Both of these
studies indicate that glyphosate is no more than slightly
toxic. An embryolarvae 48-hour acute toxicity test indicated
that glyphosate is no more that moderately toxic.
15
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Plant Protection
No studies were evaluated under this type.
Tier 1 testing is required on a case-by-case basis to
support (I) products for which phytotoxicity problems arise
and open literature data are not available (II) products that
may pose hazards to endangered or threatened species. Since
glyphosate has use patterns similar to those chemicals that
have jeopardy opinions prepared by Office of Endangered
Species (OES), the Agency is assuming that use of glyphosate
may also pose hazards to endangered plants. The Agency is
requiring that Tier 1 testing be performed with glyphosate.
Refer to charts in Appendix I for testing required.
Endangered Species
In considering the hazard to endangered species the
previous consultations with the OES were reviewed. The
Endangered Species Act requires all federal agencies to
formally consult with OES whenever an action taken by them
may affect an endangered species. The consultation provides
an opinion which may or may not indicate hazard to an endangered
species. An opinion which indicates hazard is a jeopardy
opinion. Consultations on crops (alfalfa, applesf barley,
corn, cotton, pears, and wheat), rangeland/pastureland, and
silvicultural sites has resulted in jeopardy opinions relating
to glyphosate. In order to protect the jeopardized species,
the Agency will require additional product labeling
The consultation for the crop cluster indicated jeopardy
for Solano grass, Houston toad, and the Valley elderberry
longhorn beetle. Glyphosate products with crop uses are
required to bear the labeling entitled, "Glyphosate Endangered
Species Labeling (crop sites)." Refer to Section D of Part IV
for label wording.
t
Silviculture sites were addressed under the forest cluster.
The following plant species were identified to be at risk:
green pitcher plant, Chapman rhododendron, Florida torreya,
hairy rattleweed, persistent trillum, small-whorled pogonia,
northern wild monkshood, Furbish lousewort, mountain golden-
heather, and Virginia round-leaf birch. Glyphosate products
with silvicultural uses are required to bear the labeling
entitled "Glyphosate Endangered Species Labeling (Silvicultural
Sites)." Refer to Section D of Part IV for label wording.
The OES has indicated jeopardy for the following plants
when rangeland/pastureland is treated with herbicides: green
pitcher plant, Arizona agave, Nichol's Turk's head cactus,
Arizona hedgehog cactus, Brady pincushion cactus, Peebles
Navajo cactus, Siler pincushion cactus, Arizona cliffrose,
Carex specuicola, Thornber's fishhook cactus, large-flowered
16
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fiddleneck, San Benito evening-primrose, salt marsh birds-beak,
San Clemente Island Indian paintbrush, San Clemente Island
larkspur, Eureka dune grass, Solano grass, Antioch Dunes
evening-primrose, San Clemente Island bush-mallow, San Diego
mesa mint, San Clemente Island broom, Raven's manzanita,
Santa Barbara Island liveforever, Pedate checker-mallow,
slender-petaled mustard, Contra Costa wallflower, McDonald's
rockcress, Truckee barberry, Uinta Basin hookless cactus,
Mesa Verde cactus, North Park phacelia, clay-loving wild-
buckwheat, purple-spined hedgehog cactus, knowlton cactus,
spineless hedgehog cactus, Clay phacelia, Hairy rattleweed,
Nehe, Harper's beauty, Miccosukee gooseberry, Gouania
hillebrandll, Stenogyne angustifolia var. angustifolia,
Haplostachys haplostachya var. angustifolia, Ewa Plains'
a. <:oko , Diamond Head schiedea, Liochaeta venosa, caneate
bidens, MacFarlane's four-o'clock, Short's goldenrod, Robbins
cinquefoil, Lee pincushion cactus, Sneed pincushion cactus,
Kuenzler hedgehog cactus, McKittrick pennyroyal, Todsen's
pennyroyal, gypsum wild-buckwheat, Rhizome fleabane, Cirslum
vinaceum, bunched arrowhead, Malheur wire-lettuce. Tennessee
purple coneflower, Ashy dogweed, Tobusch fishhook cactus,
Nellie cory cactus, bunched cory cactus, Lloyd's hedgehog
cactus, black lace cactus, Davis' green pitaya, Lloyd's
mariposa cactus, Johnston's frankenia, Texas poppy-mallow,
Texas snowbells, Novasota ladies'-tresses, Texas wild-rice;
Maguire daisy, Wright fishhook cactus, Rydberg milk-vetch,
Dwarf bear-poppy and Last Chance townsendia. As a result of
this consultation, glyphosate products with uses for range
and pastureland are required to bear the labeling entitled
"Glyphosate Endangered Species Labeling (Range and Pastureland
Uses)." Refer to Part D of Section IV for label wording.
Endangered species labeling may be required for aquatic
and noncrop uses when the respective generic consultations
from Office of Endangered Species are available.
The following registered uses of glyphosate have not :
been reviewed in the cluster project or in registration
submissions: almond, apricot, artichoke (Jerusalem), asparagus,
avocado, banana, beans, beet greens, beets (red), bermudagrass
(seed crop), broccoli, cabbage, carrot, cauliflower, celery,
cherry, chicory, citrus, coffee, cranberry, filbert, gardens,
grapes, grasses grown for seed, guava, horseradish, kale,
lentils, lettuce, macadamia nuts, mango, mustard greens,
nectarine, okra, onions, papaya, parsnips, peachs, peanuts^
peas, pecans, pineapple, pistachio, plum, potato (Irish), '
prune, radish, rutabaga, spinach, sugar beets, sugarcane,
sweet potato, tea, turnips, walnut, watercress, and ornamentals
17
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Tolerance Reassessment
Tolerances have been established for residues of glyphosate
in a variety of raw agricultural commodities, in meat, fat,
and meat byproducts (40 CFR 180.364) and in processed food
(21 CFR 193.235) and feed (21 CFR 561.253). EPA has evaluated
the residue and toxicology data supporting tolerances, and
has addressed the following questions:
a. Whether the available data support all currently
registered use patterns (including those registered
under FIFRA section 24(c) and intrastate uses a.id
methods of application).
b. Whether the existing uses of glyphosate require the
establishment of tolerances in animal products because
of residues that may transfer to animals from feed
items derived from raw agricultural commodities.
c. Whether food additive regulations are necessary
because residues in the raw agricultural commodity
concentrate in processing.
d. Whether group tolerances could be established in
accordance with 40 CFR 180.34(f).
e. Whether, in the absence of tolerances, restrictions
on use, grazing, or feeding of treated commodities
are necessary.
f. Whether the tolerances are expressed accurately and
in current terminology.
The regulatory results of the Agency's review are set out
in Section IV A, Regulatory Positions and Rationales.
Residue Data
The residue data reviewed in support of these tolerance's
include the following:
a. Data on the nature of the residues in both plants and
animals, including identification of major metabolites
and degradates of glyphosate. Available data indicate
that the major metabolite of glyphosate is aminomethyl-
phosphonic acid (AMPA). The established tolerances
are based on occurrence of glyphosate and AMPA in
plants and animals.
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b. Radiolabeled studies on the uptake, translocation, and
metabolism of glyphosate in plants which show that
the parent compound, glyphosate, and its metabolite,
AMPA, are the residues of concern in plants.
c. Radiolabeled studies on the uptake, translocation,
and metabolism of glyphosate in poultry, swine,
cattle, rats, and rabbits which show that glyphosate
and its metabolite, AMPA, occur in liver of poultry,
swine, and cattle and kidney of swine and cattle.
These residues have also been identified in the
tissues, urine, and feces of rats and rabbits.
d. Analytical methodology for determining levels of
residues of glyphosate in plants, animals, and
water. The available gas liquid chromatography
(GLC) method for analysis in milk, eggs, and animal
tissues is adequate for data collection and enforce-
ment. Available methods for analysis of residues
of glyphosate and its major metabolite, AMPA, in or
on plant commodities or water are adequate for data
collection.
e. Storage stability data demonstrating residues of
glyphosate. Available data are sufficient to ascer-
tain that residues of glyphosate and its AMPA metabo-
lite are stable in or on frozen plant products for
up to 7 months. No data were submitted concerning
storage stability of glyphosate in or on animal
products (tissue, milk, or eggs) or water.
f. Data on magnitude and levels of residues of glyphosate
in individual raw agricultural commodities, animal
products, and processed food and feed items.
Toxicology Data
The toxicology data considered in support of the tolerahces
include: a chronic feeding study in mice with a NOEL of 5000
ppm; a chronic feeding study in rats with a NOEL greater than
31 mg/kg/day; a rat teratology study with a fetotoxic and
maternal NOEL of 1000 mg/kg/day and no observed teratogenic
effects; a rabbit teratology study with a maternal toxicity
NOEL of 175 mg/kg/day, a fetotoxicity NOEL of 350 mg/kg/day
and no observed teratogenic effects; a three-generation
reproduction study in rats with a NOEL of 10 mg/kg/day; and
19
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several mutagenlcity studies, all negative. Refer to the
toxicology section above for detailed information on available
data and additional requirements.
The acceptable daily intake (ADI) for glyphosate is
currently based on the finding of renal tubular dilation
in ?3t) pups in the rat three-generation reproduction study.
The NOEL for this effect was 10 mg/kg/day. Using a hundred-
fold safety factor, the ADI for glyphosate is 0.1 mg/kg/day,
which is equivalent to a maximum permissible intake (MPI) of
6.0 mg/day in a 60-kg individual. Existing tolerances produce
a theoretical maximum residue contribution (TMRC) of 1.4238
rag/clay from a 1.5 kg diet which occupies 23.73 percent of the
ADI.
Tolerances Issued
Refer to 40 CFR 180.364, 21 CPR 193.235, and 21 CFR
561.253 for tolerances established on glyphosate and its
metabolite aminomethylphosphonic acid.
Canadian tolerances have been established for residues
of glyphosate in or on carrots, sugar beets, lettuce, cabbage,
beans, peas, soybeans, citrus, pome fruits, stone fruits,
grapes, cereals, grasses, and forage legumes at 0.1 ppm.
No Mexican or Codex tolerances have been established for
glyphosate.
IV. REGULATORY POSITION AND RATIONALE
A. REGULATORY POSITION AND RATIONALE
t
1. None of the risk criteria listed in 40 CPR 154.7 have
been exceeded for glyphosate. Therefore, no referral to
Special Review is being made at this time. The Agency is
requiring a repeat of the mouse and rat oncogenicity studies.
Rationale: A review of the data indicates no risk criteria
have been exceeded or met. A review of the mouse oncogenicity
study noted a slight increase in the incidence of renal tubular
20
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adenomas. Based on reviews by the Toxicology Branch Ad Hoc
Oncogenicity Committee and the Science Advisory Panel, the
Agency concluded that the mouse study was not adequate to
define the oncogenic potential of glyphosate. A review of
the rat oncogenicity study determined that a maximum tolerated
dose had not been reached; therefore, the rat study was also
inadequate to determine oncogenic potential. Refer to Part
III - Agency Assessments for detailed discussion of data.
2. The Agency will issue registrations for substantially
similar products and will issue significant* new uses on a
case-by-case basis.
Rationale: The available data do not clearly demonstrate
whether glyphosate is an oncogen. However, even if it is
assumed to be an oncogen, the data suggests that it would be
relatively weak. Pending completion and review of the required
chronic feeding studies the Agency would use the Q* from the
existing mouse study and other relevant data in assuming the
potential risk from addition of any significant new use.
3. The Agency is not imposing a ground water advisory
statement for glyphosate.
Rationale; Available data indicate that glyphosate is strongly
adsorbed to the soil; therefore, the potential of glyphosate
to contaminate ground water is expected to be low- Refer to
the Environmental Characteristics Section of Part III - Agency
Assessments for a detailed discussion of available data.
4. The Agency is not imposing any reentry statements nor
is it requesting that reentry data be submitted.
Rationale; Available acute dermal toxicity data place technical
glyphosate and its formulated products for agricultural use
in Toxicity Category III. Based on glyphosate's low acute
toxicity and the fact that the major routes of exposure are
via splashing during mixing and loading, it is not expected;
that field workers would be exposed to acutely toxic levels
of glyphosate following agricultural treatments. Therefore,
reentry data or intervals are not required by the Agency.
5. The Agency is requiring that labeling on all end-use
products except those labeled for homeowner use only bear
"Worker Safety Rules" requiring protective clothing
requirements (face shield or goggles), chemical resistant
*Significant new use is defined in 44 FR 27934, May 11, 1979.
In the case of a new food or feed use, the Agency will
consider as significant an increase in Theoretical Maximum
Residue Contribution of greater than 1 percent.
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gloves, chemical resistant apron and chemical resistant shoes,
shoe coverings, or boots). Refer to Section D of Part IV for
detailed wording.
Rationale; The major routes of exposure are dermal and ocular
via splashing during mixing or loading. Exposure to all
formulations of glyphosate during application is expected to be
dermal. Information from the California Department of Food and
Agriculture reported incidents of worker poisonings or illnesses
due to skin or eye irritation. Although technical glyphosate
has very low toxicity (not irritating), formulations of
glyphosate for agricultural use cause moderate eye irritation
and some dermal irritation. The "Worker Safety Rules" required
will reduce the exposure of workers to formulations of glyphosate,
The formulated products labeled for homeowner uses only are of
very low concentration and available data show they are not
very irritating to either skin or eyes.
6. The Agency is imposing endangered species labeling
for crops (alfalfa, apples, barley, cotton, pears, and wheat),
rangleland and pastureland, and silvicultural sites. Refer
to Section IV D for labeling requirements.
Rationale; Consultations with the Office of Endangered Species
resulted in jeopardy opinions for several species (refer to
Endangered Species Section of Part III for lists of species).
The proposed labeling is intended to reduce the hazard to
endangered or threatened species.
7. The Agency is imposing a label restriction prohibiting
the rotation of food or feed crops in glyphosate treated
soils unless glyphosate is registered for use on those crops.
This restriction will be in effect until the requested
rotational crop data are submitted and reviewed. Refer to
Section IV Part D for exact wording.
Rationale; Rotational crop data are unavailable for glyphosate.
Therefore the Agency cannot determine a length of time after
treatment of soil with glyphosate that food or feed crops may
be planted without exposure to residues of glyphosate. This
statement is to ensure that food or feed crops without
tolerances are not exposed to residues of glyphosate.
8. The Agency is imposing a label restriction prohibiting
the use of glyphosate on rice fields in which crayfish and
catfish are included in cultural practice.
•22
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Rationale: Tolerances are not established for residues of
glyphosate in crayfish and catfish. This restriction is to
ensure that crayfish and catfish harvested for human food are
not exposed to residues of glyphosate.
9. The Agency is imposing label restrictions prohibiting
the use of water containing glyphosate from rice cultivation
for irrigation of feed or food crops not appearing on
glyphosate labels.
Rationale: Data are not available to support the use of
water containing glyphosate for irrigation purposes on feed
or feed crops not appearing on the label. These restrictions
are to ensure that food or feed crops not having tolerances
are not exposed to residues of glyphosate.
10. The Agency will not require additional residue data
on the following raw agricultural commodities: garden beets;
carrots; potatoes; rutabagas; sugar beets; sweet potatoes;
garden beet tops; chicory tops; sugar beet tops; celery;
lettuce; spinach; cauliflower; kale; mustard greens; dried
beans; lentils; lima beans; peas (succulent or dried); snap
beans; soybeans; bean vines and hay; lentil forage and hay;
soybean forage and hay; grapes; barley grain; corn grain
(including popcorn), and sweet corn (kernels plus cob with
husks removed); oat grain; rice grain; wheat grain; barley
forage, hay, and straw; corn forage, silage, and fodder; oat
forage, hay, and straw; rice straw; wheat forage, hay, and
straw; avocados; bananas (including plantains); cotton; guava;
okra; papayas; pineapple; pistachionuts; and watercress.
Additional residue data are not required for the following
processed food or feeds: soybean hulls, almond hulls, barley
milled products, oat milled products; and sugarcane molasses.
Additional residue data are not required for the following
crop groupings: legume vegetables; foliage of legumes ;
vegetables group; pome fruits group; treenuts; grass forage;
fodder and hay group; and forage and hay of nongrass animal
feeds.
Rationale; The Agency has determined that the available
residue data adequately support the established tolerances
for these raw agricultural commodities, foods, feeds, and
crop groups.
11. The Agency is requiring that additional residue data
and/or Information be submitted on the following raw agricul-
tural commodities: parsnips; turnips, turnip greens; onions;
cranberries; sorghum grain; asparagus; coffee; mangos; peanuts,
23
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peanut forage, hay, and hulls; and sugarcane. Additional
residue data and/or information are required on the following
processed foods or feeds; potato granules, chips and dried
potatoes; processed commodities of sugar beets (dehydrated
pulp,, molasses, and refined -sugar); dried citrus pulp; prunes;
processed products of grapes; corn oil (crude and refined);
corn-milled products; processed products of grain and sorghum;
wheat-milled products; alfalfa seed; and processed olives,
and olives. Additional residue data and/or information are
required on the following crop groups: root and tuber vege-
tables; leaves of root and tuber vegetables, bulb vegetables
groups; leafy vegetables (except brassica vegetables group,
brassica leafy vegetables group; fruiting vegetables (except
cucurbits) group; citrus fruits group; small fruits and
berries group; and cereal grains group. Refer to the data
tables in Appendix I for a detailed discussion of types of
data and/or information needed.
Rationale: The Agency has determined that the available
residue data do not adequately support the established
tolerances for these raw agricultural commodities, foods,
feeds and crop groups.
12. The Agency requires residue data together with a
petition for establishing tolerances, if necessary, for
sugarcane forage and pineapple forage. Alternatively, a
statement may be placed on the label restricting the grazing
or feeding of treated commodities. Each registrant will have
6 months to notify the Agency which alternative it chooses.
Refer to the data tables in Appendix I for details of residue
data required.
Rationale; Review of available data indicates that residue
data are required to determine whether residues are transferred
to animals from feed items. A grazing restriction prevents
the transfer of residues from animals to feed items.
13. The Agency intends to disapprove the registrations
of the following 24(c) registrations (KS820001, M0820014,
NE820009, NM820001, OK820010, and TX820023. Alternatively,
residue data and petitions for tolerances must be submitted
proposing tolerances on sorghum forage, fodder, and hay
reflecting these uses. Each registrant will have 6 months
to notify the Agency which alternative he chooses. Refer to
the data tables in Appendix I for details of the residue
data required.
Rationale: Available residue data do not support this use
pattern.
. 24
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14. The Agency is requiring the following changes in
the tolerance listings.
a. The tolerance for residues in or on root crop
vegetables should be deleted and individual tolerances
established or proposed for individual members of the root
and tuber vegetables crop group.
b. The tolerance for residues in or on seed and
pod vegetables should be deleted and individual tolerances
established for members of the former seed and pod vegetables
group on which use of glyphosate is registered.
c. The entry "Nuts" will be amended read "Tree
Nuts."
d. The tolerance for residues in or on leafy
vegetables should be deleted and tolerances established for
residues in or on individual members of the leafy vegetable
crop group.
e. The existing tolerances for alfalfa, clover,
and forage legumes should be deleted and separate tolerances
for residues of glyphosate and AMPA of 100 ppm should be
established for residues of forage and hay of nongrass animal
feeds.
f. The existing tolerance for residues in or on
forage legumes should be deleted and separate tolerances of
0.2 ppm should be established in or on legume vegetables
(except soybeans) and the foliage of legume vegetables, except
soybean forage and hay.
g. The established tolerances for forage grasses,
grasses, forage, Bahiagrass, bermudagrass, bluegrass,
bromegrass, fescue, orchardgrass, ryegrass, timothy and wheat
grass should be deleted and a separate tolerance of 100 ppm,
for residues in or on grass forage and hay must be established,
Rationale; The crop groupings as listed have been superseded
by publication of new crop groupings. (Refer to 40 CFR 180.34.
15. The tolerance for cottonseed forage and hay must be
cancelled.
Rationale: These tolerances are inappropriate because cotton
hay is not fed to animals; therefore, hay is not considered
c-. raw agricultural commodity of cotton. Since a grazing
restriction prohibits feeding of cotton forage, no residues
are transferred to animals from the feed item cotton forage.
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16. The food additive tolerances for instant tea from
imported dried tea will be raised from 4 ppm to 7 ppm.
Rationale; The available processing data indicate that
residues of glyphosate concentrating in the processed commodity
instant tea are 5 to 7 times more than in the processed
commodity imported dried tea. Available data support the
established tolerance of 1 ppm on imported dried teas.
17. The Agency is requiring additional data on crops
treated with irrigation water containing residues of glyphosate.
Once these data are submitted, the crop groupings presently
listed in § 180.364(c) must be deleted and tolerances based
on the requested field irrigation tests must be established
for glyphosate residues in or on members of the current,
appropriate crop groups and all major irrigated crops which
ar^ not included in a crop group, such as cottonseed, sugarcane,
peanuts, etc.
Rationale; Available data are not sufficient to determine
the magnitude of glyphosate residues in or on crops treated
with irrigation water containing residues of glyphosate.
18. While data gaps are being filled, currently registered
manufacturing use products (MPs) and end use products (EPs)
containing glyphosate as the sole active ingredient may be
sold, distributed, formulated, and used, subject to the terms
and conditions specified in this Standard. Registrants must
provide or agree to develop additional data, as specified in
the Data Appendices, in order to maintain existing registrations,
Rationale; Under FIFRA, the Agency may choose not to cancel
or withhold registration if data are missing or are inadequate
(see FIFRA sec. 3(c)(2)(B) and 3(c)(7).
Issuance of this Standard provides a mechanism for
identifying data needs. These data will be reviewed and
evaluated, after which the Agency will determine if additiohal
regulatory changes are necessary.
B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard,
products must contain glyphosate as the sole active ingredient,
bear required labeling, and conform to the product composition,
acute toxicity limits, and use pattern requirements listed in
this section.
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C. ACCEPTABLE RANGES AND LIMITS
1. Product. Composition Standard
To be registered or reregistered under this Standard,
manufacturing-use products (MP's) must contain glyphosate as
the sole active ingredient. Each MP formulation proposed for
registration must be fully described with an appropriate
certification of limits, stating maximum and minimum amounts
of the active ingredient and inert ingredients which are
present in products, as well as impurities found at greater
than 0.1 percent.
2. Acute Toxicity Limits
The Agency will consider registration of technical
grade and manufacturing-use products containing glyphosate
provided that the product labeling bears appropriate pre-
cautionary statements for the acute toxicity category in
which each product is placed.
D. REQUIRED LABELING
All MPs (and EPs if covered by Standard) must bear
appropriate labeling as specified in 40 CFR 162.10. Appendix
II contains information on label requirements. All labeling
changes must appear on all products in channels of trade by
June 30, 1988.
In addition to the above, the following information must
appear on the labeling:
1. Ingredients Statement
The ingredient statement for MP's must list the active
ingredient as:
\
Glyphosate, N-phosphonomethyl glycine
2. Precautionary Statements
Statements for Manufacturing-Use Products
Do not discharge effluent containing this
product into lakes, streams, ponds, estuaries,
oceans, or public waters unless this product
is specifically identified and addressed in
an NPDES* permit. Do not discharge effluent
*National Pollution Discharge Elimination System.
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containing this product to 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
Outdoor Uses
Products not labeled for aquatic use
Do not apply directly to water or wetland
(swamps, bogs, marshes, and potholes). Do
not contaminate water by cleaning of equipment
or disposal of waste.
Products Labeled for Aquatic Use
Do not contaminate water by cleaning of
equipment or disposal of waste. Treatment
of aquatic weeds can result in oxygen loss
from decomposition for dead plants. This
loss can cause fish suffocation.
3. The following label statements must appear on all
end-use products.
Rotational Crop
Do not use glyphosate on rice fields in
which crayfish and catfish farming are
included in the cultural practice and do not
plant crops other than those with registered
glyphosate uses for food or feed in glyphosate-
treated soil.
Irrigated Crops )
Do not use water containing glyphosate
residues from rice cultivation to irrigate
food or feed crops not listed on the glyphosate
label.
4. The following Worker Safety Rules must appear on end-
use products containing glyphosate except for those labeled
for homeowner use only.
28
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Worker Safety Rules
THIS PRODUCT CAUSES EYE IRRITATION AND SKIN IRRITATION
Keep all unprotected-" persons, children, livestock,
and pets away from treated areas or where there is
danger of drift.
Do not rub eyes with hands. If you feel sick in any
way, STOP work and get help right away. See First Aid
(Practical Treatment) section.
HANDLE THE CONCENTRATE ONLY WHEN WEARING THE PROTECTIVE
CLOTHING AND EQUIPMENT.
Wear goggles or a face shield, chemical-resistant
gloves, chemical resistant apron, and chemical-resistant
shoes, shoe coverings, or boots.
WEAR THE FOLLOWING PROTECTIVE CLOTHING DURING
APPLICATION, EQUIPMENT REPAIR, CLEANING, DISPOSAL OF
THE PESTICIDE SPRAY SOLUTION, AND DURING REENTRY TO
TREATED AREAS BEFORE THE SPRAY HAS DRIED.
Wear goggles or a face shield, chemical-resistant
gloves and chemical-resistant shoes, shoe covers, or
boots. A helmet with visor may be worn during open
cockpit aerial application.
During application only from a tractor with a completely
enclosed cab or aerially with an enclosed cockpit the
above protective clothing is waived. Chemical-resistant
gloves must be available in the cab or cockpit and
must be worn while exiting.
IMPORTANT! Before removing gloves, wash them with .
soap and water. Always wash hands, face, and arms
with soap and water before smoking, eating, drinking,
or toileting.
AFTER WORK, wash protective clothing and protective
equipment with soap and water after each use. Personal
clothing worn during use should be laundered separately
from household articles. Clothing or protective
equipment heavily contaminated or drenched with
glyphosate must be disposed of in accordance with
State and local regulations.
HEAVILY CONTAMINATED OR DRENCHED CLOTHING CANNOT BE
ADEQUATELY DECONTAMINATED.
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5. The following Endangered Species labeling Is required
for all end-use products labeled for the following use patterns,
Glyphosate products with silviculture uses are required
to bear the following labeling:
Glyphosate Endangered Species Labeling
(Silvicultural Sites)
ENDANGERED SPECIES RESTRICTIONS
The use of any pesticide in a manner that may kill or
otherwise harm an endangered or threatened species or
adversely modify their habitat is a violation of
Federal law. The use of this product is controlled
to prevent death or harm to endangered or threatened
species that occur in the following counties or
elsewhere In their range.
Before using this pesticide in the following counties
you must obtain the EPA Forest Herbicide Endangered
Species Bulletin (EPA/ES-FOREST). The use of this
pesticide is prohibited In these counties unless
specified otherwise In the Bulletin. The Forest
Herbicide Bulletin is available from either your
County Agricultural Extension Agent, the Endangered
Species Specialist in your State Wildlife Agency
Headquarters, or the appropriate Regional Office of
either the U.S. Fish and Wildlife Service (FWS) or
the U.S. Environmental Protection Agency (EPA)
indicated below. THIS BULLETIN MUST BE REVIEWED
PRIOR TO PESTICIDE USE.
Contact FWS or EPA in Atlanta, Georgia
ALABAMA: counties of Cherokee, DeKalb, Marshall, /
Jackson, and Etowah
FLORIDA: counties of Clay, Gadsden, Gulf, Liberty,
and Jackson
GEORGIA: counties of Decatur, Towns, Wayne, Brantley,
Rabun, Habersham, and Stephans
NORTH CAROLINA: counties of Burke, Macon, and
Henderson
SOUTH CAROLINA: Oconee county
3.0
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Contact FWS In Newton Corner, Massachusetts or EPA in
Philadelphia, Pennsylvania
NEW JERSEY: Sussex . county
PENNSYLVANIA: counties of Venango and Centre
VIRGINIA: counties of Smyth, Caroline, and James City
Contact FWS in Newton Corner, Massachusetts or EPA in
Boston, Massachusetts
MAINE: counties of Arrostook, Cumberland, and Kennebec
MASSACHUSETTS: counties of Hampshire and Essex
NEW HAMPSHIRE: counties of Strafford, Belknap,
Merrimack, Rockinghara, and Carroll
RHODE ISLAND: Providence county
Glyphosate products with uses for rangeland and
pastureland are required to bear the following labeling:
Glyphosate Endangered Species Labeling (Rangeland and
Pasture Uses)
The use.of any pesticide in a manner that may kill or
otherwise harm an endangered or threatened species or adversely
modify their habitat is a violation of Federal law. The use
of this product is controlled to prevent death or harm to
endangered or threatened species that occur in the following
counties or elsewhere in their range.
Before using this pesticide in the following counties
you must obtain and review the EPA Rangeland and Endangered .'
Species Bulletin (Bulletin EPA/ES-RANGE). The use of this
pesticide is prohibited in these counties unless specified
otherwise in the Bulletin. The Rangeland Bulletin is available
from your County Agricultural Extension Agent, the Endangered
Species Specialist in your State Wildlife Agency Headquarters,
or the appropriate Regional Office of the Wildlife Agency
Headquarters or the appropriate Regional Office of the U.S.
Pish and Wildlife Service (PWS) or the U.S. Environmental
Protection Agency (EPA) indicated below. THIS BULLETIN MUST
BE REVIEWED PRIOR TO PESTICIDE USE.
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Contact FWS in Portland, Oregon or EPA In San Francisco,
California
CALIFORNIA: counties of San Benito, Monterey, San
Luis Obispo, Fresno, Kings, Kern, Santa Barbara,
Ventura, Tulare, San Joaquin, San Diego, Los Angeles,
Inyo, Solano, San Francisco, San Bernardino, Contra
Costa, Mendocino, and Nevada
HAWAII: Island of Maul, District of Lahaina, Island
of Hawaii, and Island of Oahu
Contact FWS in Portland, Oregon or EPA in Seattle, Washington
IDAHO: Idaho county
OREGON: counties of Harney and Wallowa
Contact FWS in Albuquerque, New Mexico or EPA in San
Francisco, California
ARIZONA: counties of Yavapai, Maricopa, Final, Piraa,
Gila, Navajo, Mohave, and Graham
Contact FWS in Albuquerque, New Mexico or EPA in Dallas,
Texas
NEW MEXICO: counties of Eddy, Dona Ana, Otero, Chaves,
Lincoln, San Juan, Sierra, McKinley, and Catron
TEXAS: counties of El Paso, Culberson, Zapata, Bandera,
Kerr, Brewster, Terrell, Pecos, Jim Wells, Kelburg,
Refugio, Starr, Runnels, Edwards, Real, Kimble, Val
Verde, Brazos, and Hays
Contact FWS or EPA in Atlanta, Georgia •'
ALABAMA: counties of Cherokee, De Kalb, Jackson,
and Marshall
FLORIDA: counties of Franklin, Liberty, and Jefferson
GEORGIA: counties of Towns, Wayne, and Brantley
KENTUCKY: counties of Nicholas, Fleming, and Robertson
NORTH CAROLINA: Henderson county
32
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SOUTH CAROLINA: counties of McCormick andvGreenville
TENNESSEE: counties of Rutherford, Wilson, and Davidson
Contact FWS or EPA in Boston, Massachusetts
NEW HAMPSHIRE: Coos county
Contact FWS or EPA in Denver, Colorado
COLORADO: counties of Delta, Mesa, Montrose.
Montezuma, Jackson, Washington, La Plata, and
Duray
UTAHj counties of Washington, San Juan, Duchesne,
Summit, Emery, Wayne, Piute, Garfield, Utah, and
Sevier
Glyphosate products labeled for use on field crops (corn,
cotton, soybeans, sorghum, small grains, alfalfa, and for
apples and pears) must bear the following label:
[GLYPHOSATE (LABELING INFORMATION FOR FIELD CROP USES:
CORN, COTTON, SOYBEANS, SORGHUM, SMALL GRAINS, ALFALFA,
AND FOR APPLES AND PEARS)]
ENDANGERED SPECIES RESTRICTIONS
The use of any pesticide in a manner that may kill or
otherwise harm an endangered or threatened species or
adversely modify their habitat is a violation of Federal law.
The use of this product is controlled to prevent death or
harm to endangered or threatened species that occur in
the following counties or elsewhere in their range:
STATE
Species
(BULLETIN NO. )
CALIFORNIA
Solano grass
(EPA/ES-85-13)
Valley elderberry
longhorn beetle
(EPA/ES-85-08)
TEXAS
Houston toad
(EPA/ES-85-28)
County
Corn
Cotton
Wheat
Barley
Pears
Apples
SOLANO
MERCED
BURELSON
BASTROP
Soybeans
Sorghum
HARRIS
Alfalfa
33
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Before using any pesticide in the above counties you must
obtain the EPA Bulletin specific to your area. The use of
this pesticide is prohibited in the above-named counties
unless specified otherwise in the Bulletins. The EPA
Bulletins are available from either your County Agricultural
Extension Agent, the Endangered Species Specialist In
your State Wildlife Agency Headquarters, or the appropriate
Regional Office of the U.S. Pish and Wildlife Service or
the U.S. Environmental Protection Agency. THIS BULLETIN MUST
BE REVIEWED PRIOR TO PESTICIDE USE.
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submission or changes in composition, labeling or
packaging of the product. The applicable requirements depend
on whether the product is a manufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1* The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B^
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms, Confiden-
tial Statement of Formula, data compensation provisions)
associated with reregistration.
2 Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registra-
tion Standard. Table B lists product-specific data applicable
to manufacturing use products. The data in Tables A and B
need not be submitted by a producer who is eligible for the
formulator's exemption for that active ingredient.
Table C lists product-specific data applicable to end use
products. The Agency has decided that, in most cases, it
will not require the submission of product-specific data for
end use products at this time. Therefore most Registration
Standards do not contain a Table C. 3c
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B. Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:
The data requirements listed in Table A.
C. End use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to the
end use product.
2. If eligible for the formulator's exemption^, the
data requirements listed in Table C.
3. If not eligible for the 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 subje'ct to:
a. If not eligible for the formulator's exemption,
the date requirements listed in Tables A and C.
b. If eligible for the forrnulator's exemption, the
data requirements listed in Table C.
3 If you purchase from another producer and use as the
source of your active ingredient only EPA-registered products,
you are eligible for the formulator's exemption for generic
data concerning that active ingredient (Table A) and product-
specific data for the registered manufacturing use product
you purchase (Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient,
or acquire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption
and become subject to the data requirements in Table A.
2) If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end use
producers lose the exemption, and become subject to those
data requirements.
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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). E'PA 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 not now eligible for a formulator's exemption,
you may qualify for one if you change your source of supply •
to a registered source that does not share ownership in
common with your firm. If you choose to change sources of
supply, the Confidential Statement of Formula must identify
the new source(s) and you must submit a Formulator's Exemption
Statement form.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic
data relevant to the uses of your product if, at the time
4 Registrations granted after issuance of this Standard
will be conditioned upon submission or citation of the data
listed in this Registration Standard.
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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, and either—
(a) Submit the existing data- that you believe will
satisfy the data requirements, or
(b) State that you will secure the data or have made
a contract to have any necessary studies completed
within the applicable time period. -:
2. You have entered into an 'agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also provide
EPA with documentary evidence that an agreement has been
formed which allows you to rely upon the data to be submitted.
Such evidence may be: (1) your letter offering to join in
an agreement and the other registrant's acceptance of your
offer, (2) a written statement by the parties that an agreement
exists, or (3) a written statement by the person who will be
submitting the data that you may rely upon its submission.
The Agency will also require adequate assurance that the
person whom you state will provide the data is taking appropriate
steps to secure it. The agreement to produce the data need
not specify all of the terms of the final arrangement
the parties or a mechanism to resolve the terms.
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3. You have attempted to enter into an agreement to
jointly develop data, but no other registrant has accepted
your offer. You request that EPA not suspend your registration
for non-compliance with the PCI. EPA has determined that,
as a genera-l policy, it will hot suspend the registration of
a product when the registrant has in good faith sought and
continues to seek to enter into a data development/cost
sharing program, but the other registrants developing the
data have refused to accept its offer. [If your offer is
accepted, you may qualify for Option 2 above by entering
into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must,
at a minimum, contain the following language or its equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [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 offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you;
may qualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share in the burden of developing the
data. In addition, the other registrant must fulfill its
commitment to develop and submit the data.
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 automatically
extend the timeframes for developing required data, and if
your waiver request is denied, your registration may be
suspended if you fail to submit the data. " -?Q
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5. You request that EPA amend your registration by deleting
the uses for which the data are needed. You are not required
to submit data for uses which are no longer on your label.
6» You request voluntary cancellation of the registration
of your product(s) for which the data are needed*
E. Procedures for reguesting a change in testing protocol.
If you will generate the required data and plan to use
test procedures which deviate from (or are not specified in)
either EPA's Pesticide Assessment Guidelines or the Reports
of Expert Groups to the Chemicals Group, Organization for
Economic Cooperation and Development (OECD) Chemicals Testing
Programme, you must submit for EPA approval the protocols
you propose to use.
You should submit your protocols before beginning testing
and await EPA approval, because the Agency will not ordinarily
accept as sufficient studies using unapproved protocols.
A request for protocol approval will not automatically extend
the timeframe for submission of the data, nor will extensions
generally be given to conduct studies due to submittal of
inappropriate protocols.
F. Procedures for requesting extensions of time.
If you plan to submit the data, and 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.
The extension request must be submitted in writing to the Product
Manager listed at the end of this section and must be made
before the deadline for response. EPA will view failure to
request an extension before the response deadline as a waiver
of any future claim that there was insufficient time to 7
submit the data. While EPA considers your request, you must
strive to meet the deadline for submitting the data.
The extension request should state the reasons why you
believe that an extension is necessary and the steps you
have taken to meet the testing deadline. Time extensions
normally will not be granted due to problems with laboratory
capacity or adequacy of funding, since the Agency believes
that with proper planning these can be overcome. Time extensions
may be considered when joint data development is planned,
or when the Agency must approve a new or modified protocol
before the study can be begun.
A request for an extension does not automatically 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 regis-
trations of your products.
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G. Existing stocks provision upon suspension or cancellation.
EPA will permit continued sale and distribution of existing
stocks of a pesticide product which has been suspended or
cancel-1-ed if doing so would be consistent with the purposes
of the Act. However/ the Agency has determined that if a
registration is suspended for failure to respond to a DCI
request under FIFRA sec. 3(c)(2)(B), an existing stocks
provision is not consistent with the Act. Accordingly, the
Agency does not anticipate granting permission to sell or
distribute existing stocks of suspended product except in
rare circumstances. If you believe that your product will
be suspended or cancelled and that an existing stocks provision
should be granted, you have the burden of clearly demonstrating
to EPA that granting such permission would be consistent with
the Act. The following information must be included in any
request for an existing stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of
existing stocks and your estimate of the time required
for their sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
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VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing
using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time. Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
«
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section IV.D, E, F, and G. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options IV.D.I. (submit data)
or IV.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.
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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 issue a Notice of Intent to Cancel
the registration of your product under FIFRA sec. 6(b)(l).
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IX. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing Products (MUPs) containing p.i-,
'.as sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division
for each product subject to this Registration Standard:
a. The "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA
Form 8580-1), with appropriate attachments.5
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form ).
d. Product Specific Data Report (EPA Form 8580-4).
e. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.80-152.99.
2. Within 12 months from receipt of this document you
must submit to the Product Manager:
a. Two copies of any required product-specific data
(See Table B or C).
b. 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. ••
5 If on the Summary Sheet, you commit to develop the data,
present arguments that a data requirement is not applicable
or should be waived, or submit protocols or modified protocols
for Agency review, you must submit a copy of the Summary
Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data
generated in response to this notice. This submission is in
addition to responding to the Product Manager, and should be
submitted to the Office of Compliance Monitoring at the
a'ddress qiven at the end of this section. (Actual studies
are not to be submitted to the Office^pf Compliance Monitoring.)
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3. Within the times set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the agreed
schedule cannot be met, 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.
3. Manufacturing Use Products containing Glyphosate 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 ),
if applicable.
2. Within the time frames set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the agreed
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 Glwpfaosate alone or in or 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 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 ),
if applicable.
d. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
2. Within 12 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.
45
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b. 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 -1-abeling must indicate the intended colors of the final
label, clear indication of the front panel of the label, and
the intended type sizes of the text. End use product labeling
must comply specifically with the instructions in Section IV
(Regulatory Position and Rationale).
D. Intrastate Products containing .Slyphosate_ either
as sole active ingredient or in combination with other
active ingredients.
These products are being called in for full Federal regis-
tration. Producers of these products are being sent a letter
instructing them how to submit an application for registration.
E. Addresses
The required information must be submitted to the following
address:
Robert J."Taylor (PM-25)
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
The address for submissions to the Office of Compliance
Monitoring is:
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency •'
401 M St., SW
Washington, D.C. 20460.
46
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I. DATA APPENDICES
Guide to Tables
Table A
Table B
47
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TGUIDE-1"
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.
Table 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 153. 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 48
Any other designations will be defined in a footnote to the table
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TGUIDE-2'
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that completely 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.
6. Must additional data be submitted? (Column 6). This
column indicates whether the data must be submitted to the
Agency. If column 3 indicates that the Agency already has !
data, this column will usually indicate NO. If column 3
indicates that the Agency has only partial data or no data,
this column will usually indicate YES. In some cases, even
though the Agency does not have the data, EPA will not require
its submission because of the unique characteristics of the
chemical; because data on another chemical can be used to
fulfill the data requirement; or because the data requirement
has been waived or reserved. Any such unusual situations
will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column 5 requires
that data be submitted, this column indicates when the data
are to be submitted, based on the issuance date of the Regis-
tration Standard. The timeframes are those established either
as a result of a previous Data Call-in letter, or standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
3. Footnotes (at the end of each table). S4^-explanatory.
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
Data Requirement Test
Substance
§158.120 Product Chemistry
Product Identity
61-2 - Description of Beginning TGAI
Materials and Manufacturing
Process
61-3 - Discussion of Formation of TGAI
Impurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis TGAI
Physical and Chemical Characteristics
63-2 - Color TGAI
63-3 - Physical State TGAI
63-4 - Odor TGAI
63-5 - Melting Point TGAI
63-6 - Boiling Point TGAI
Use Does EPA Bibliographic
Patterns Have Data?1 Citation1
All No N/A
All No N/A
All No N/A
All No N/A
All No N/A
All No N/A
All No N/A
All No N/A
Must Additional Timeframe
Data be for
Submitted? Submission
Yes2/3/ 6 Months
YesV 6 Months
Yes5/ 12 Months
Yes 6 Months
Yes 6 Months
Yes 6 Months
Yes 6 Months
Yes 6 Months
50
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
Data Requirement Test
Substance
§158.120 Product Chemistry - Continued
Physical and Chemical Characteristics
(Continued)
63-7 - Density, Bulk Density, or TGAI
Specific Gravity
63-8 - Solubility TGAI or PAI
63-9 - Vapor Pressure PAI
63-10 - Dissociation constant PAI
63-11 - Octanol/water partition PAI
coefficient
63-12 - pH TGAI
63-13 - Stability TGAI
63-17 - Storage Stability PAI
Use
Patterns
All
All
All
All
All
All
All
A,C
Does EPA
Have Data?1
No
No
No
No
No
No
No
Partially
Bibliographic
Citation1
N/A
N/A
N/A
N/A
N/A
N/A
N/A
00039142 00061
Must Additional
Data be
Submitted?
Yes
Yes
Yes
Yes
Yes
Yes
Yes
553 Yes6/
Time frame
for
Submissioi
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
15 Months
Other Requirements
64-1 - Submittal of samples
TGAI, PAI
All
No
00040083 00061555
00051980 00108129
00053002 00108102
N/A
Yes
6 Months
51
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
§158.120 Product Chemistry - Continued
_!_/ 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/ Details of the manufacturing process, including the relative amounts of beginning materials, a description of
equipment used to produce the product, reaction conditions, the duration of each step of the process, and purifica-
tion procedures and quality control measures for 41.04% formulation intermediate (FI), the 53.5% FI, the 62% FI,
the unregistered technical isopropylamine glyphosate salt product used to produce the FI's, and the unregistered
technical trisodium salt are required.
_3/ The name and address of manufacturer, producer, or supplier of each beginning material used to manufacture the
41.04% FI, the 53% FI, the unregistered technical products to produce the FIs and the unregistered trisodium salt
are required. Also, a copy of all available technical specifications, data sheets, and other documents in which
the manufacturer, producer, or supplier of the beginning material describes the composition and properties must be
submitted.
_4/ A discussion of each impurity believed to be present at 0.1% or more based on knowledge of the beginning materials,
all possible chemical reactions and any contamination are required for the 41.04% FI, the 53.5% FI, the 62% FI, and
the technical trisodium salt.
_5/ Five or more representative samples of the 41.04% FI, the 53.5% FI, the 62% FI, and the unregistered technical
trisodium salt analyzed for the amount of active ingredient and each impurity present at 0.1% (w/w) (including
any nitroso-amines which may be present at ~0.1 ppm) are required.
6/ No data were submitted concerning the storage stability of glyphosate in or on animal products (tissue, milk, eggs)
or water. The following additional data are required:
0 The storage intervals and conditions of storage of plant, animal, and water samples used to support all established
tolerances (ARLOW for water), for residues in or on these commodities must be submitted. These data must be accom-
panied by data depicting the percent decline in residues at the times and under the conditions specified. (No
additional stability studies are required for plant commodities stored frozen for < 7 months.) On receipt of these
data, the adequacy of the aforementioned tolerances will be reevaluated.
0 All residue data requested in this standard must be accompanied by data regarding storage length and conditions
of storage must be analyzed. These data must be accompanied by data depicting the stability of residues under
the conditions and for the time iat_ervals specified, with the exception of plant commodities stored frozen for
< 7 months.
0 If the requested metabolism data reveal the presence of metabolites of toxicological concern other than glyphosate
and aminomethylphosphonic acid (AMPA), additional data depicting the stability of such metabolites will be
required. 52
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPIIOSATE
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Timeframe
for
Submission
§158.125 Residue Chemistry
171-2 - Chemical Identity
171-3 - Directions for Use
171-4 - Nature of Residue
(Metabolism)
- Plants
TGAI
No
Yes
PA IRA
Yes
Product Label
00038771 00108133
00039141 00108140
00051983 00108151
00065753 00111945
00108097 GS0178-003
00108129
Yes
No
6 Months
No
- Livestock
PAIRA
and Plant
Metabolites
Partially
171-4 - Residue Analytical Method
- Plants
TGAI
and
Metabolites
Yes
53
00094971 00108101
00108098 00108116
00108099 00108200
00108100 GS0178-004
00028853
00036223
00037688
00038770
00044423
00051982
00053002
00053005
00060103
00078823
00078824
00108144
00108149
00108151
00108175
00108176
00108186
00111945
Yes1/
18 Months
No2/
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
Data Requirement
Test
Substance
Does EPA
Have Data?
§158.125 Residence Chemistry - Continued
171-4 - Residence Analytical Method - Continued
- Plants - Continued
- Animals
- Water
TGAI
and
Metabolites
TGAI
and
Metabolites
Partially
Yes
Bibliographic
Citation
Must Additional
Data be
Submitted?
Timeframe
for
Submission
00061559
00063714
00065751
00065752
00067425
00076805
00111949
00122715
GS0178-019
GS0178-020
GS1278-021
GS0178-022
00036231 GS1278-014
00038979 GS0178-023
00036222
00108231
GS0178-017
Yes
No
18 Months
54
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
Data Requirement
Test Does EPA
Substance Have Data?
Bibliographic Must Additional
Citation Data be
Submitted?
Timeframe
for
Submission
§158.125 Residue Chemistry - Continued
171-4 - Magnitude of the Residue
Residue Studies for Each
Food Use
Root and Tuber Vegetables Group3/
- Beets, garden
- Carrots
- Radishes
- Potatoes
- Processed Potato
Commodities (Granules,
Chips, Dried Potatoes)
- Rutabagas
- Parsnips
- Sugar beets
- Processed Sugar beet
Commodities (dehydrated
pulp, molasses, refined
sugar )
- Sweet potatoes
- Turnips
TEP Yes
TEP Yes
TEP Yes
TEP Yes
EP No
TEP No
TEP No
TEP Yes
EP No
._
TEP Yes
TEP No (- C
00108159 No4/
00108159 No4/
00108159 No4/
00108151 No4/
Yes5/
No6/
Yesf/V
00039381 No4/
00108151 ~
Yes8/
00108151 No4/
Yes9/
24 Months
18 Months
24 Months
18 Months
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
Data Requirement Test Does EPA
Substance Have Data?
§158.125 Residue Chemistry - Continued
Leaves of Root and
Tuber Vegetable Group1
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
Data Requirement
§158.125 Residue Chemistry
Brassica Leafy
Vegetable Group1 ^/
- Cabbage
- Cauliflower
- Kale
- Mustard greens
Legume Vegetables
(succulent or
dried) Group2
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
Data Requirement Test
Substance
Does EPA
Have Data?1
Bibliographic
Citation1
Must Additional
Data be
Submitted?
Timeframe
for
Submission
§158.125 Residue Chemistry - Continued
- Soybeans - continued
- Soybean hulls
EP
Yes
- Soybean soaps tock
Foliage of Legumes
Vegetable
EP
No
- Bean vines and hay
- Lentil forage and hay
- Soybean forage and hay
TEP
TEP
TEP
Yes
Yes
Yes
00015764 00061555
00015765 00108153
00015766 00108203
00015759
00015760
00015761
00015762
00015763
00015764
00015765
00015766
00015767
00024503
00033954
00038908
00040084
00061555
00108153
00108203
No
Yes26/
24 Months
00108159
00108159
00015759
00015760
00015761
00015762
00015763
00015764
00015765
00015766
00015767
00033954
00038908
00040084
00061555
000108153
000108203
N028/
No^V
No
58
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
Data Requirement Test Does EPA
Substance Have Data?1
§158.125 Residue Chemistry - Continued
Fruiting Vegetables
(except cucurbits) Group^/
Cucurbits Vegetables Group3^/
Citrus Fruits Group TEP Partially
- Dried citrus pulp EP No
Pome Fruits Group TEP Yes
Stone Fruits Group32/ TEP Partially
- Prunes EP No
Bibliographic Must Additional
Citation1 Data be
Submitted?
00039142 Yes31/
Yes3!/
00108129 No
00111949 Yes
Yes33/
Time frame
for
Submission
18 Months
24 Months
1 8 Months
24 Months
Small Fruits and Berries Group34/
- Blackberries35/
- Blueberries35/
- Cranberries TEP
- Grapes TEP
Processed products
of grapes
Raspberries35/
Strawberries35/
EP
Partially
Yes
No
00053002
00038770
00108132
Yes36/
No
Yes37/
18 Months
24 Months
59
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
Data Requirement Test Does EPA
Substance Have Data?1
§158.125 Residue Chemistry - Continued
Tree Nuts TEP Yes
- Almond hulls EP Yes
Cereal Grain Group38/
- Barley grain TEP Yes
- Barley milled products EP No
- Corn grain (including TEP Yes
popcorn) and sweet corn
(kernels plus cob with
husks removed )
- Corn oil (crude and EP No
Refined)
- Corn milled products EP No
- Oat grain TEP Yes
Bibliographic Must Additional
Citation1 Data be
Submitted?
00111945 No
00111945 No
00038908 No39/
00040087
00044422
00108203
No^O/
00023336 00040085 No39/
00023512 00048284
00037687 00108203
00038908
YesfV
Yes^V
00038908 No
00040087
00044422
00108203
Timef rame
for
Submission
24 Months
24 Months
- Oat milled products
EP
No
No42/
60
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
Data Requirement Test
Substance
§158.125 Residue Chemistry - Continued
- Rice grain TEP
Does EPA Bibliographic Must Additional Timeframe
Have Data?1 Citation1 Data be for
Submitted? Submission
Yes 00038908 No39/
00040087
00044422
- Sorghum grain
TEP
Partially
00038908 00108203
00040087 00109271
00044422
18 Months
- Grain sorghum processed EP
products
- Wheat grain TEP
No
Yes
00038908 00108203
00040086 00122715
00044426
24 Months
- Wheat milled products EP
Forage, Fodder, and Straw of
Cereal Grains Group46/
- Barley forage, hay, TEP
and straw
- Corn forage, silage, and TEP
fodder
- Oat forage, hay and straw TEP
No
24 Months
Yes
Yes
Yes
61
00038908 00044422
00040087 00108203
00023336 00040085
00023512 00048284
00037687 00108203
00038908
00038908 00044422
00040087 00108203
No47/
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
Data Requirement Test Does EPA
Substance Have Data?1
§158.125 Residue Chemistry - Continued
- Rice straw TEP Yes
- Sorghum forage, fodder, TEP Partially
silage and hay
Bibliographic
Citation1
00038908
000400H7
00044422
00038908 00108203
00040087 00109271
Must Additional
Data be
Submitted?
No47/
Yes47/48/
Time frame
for
Submission
18
Months
Wheat forage, hay, and TEP
straw
Grass Forage, Fodder, TEP
and Hay Group
Nongrass Animal Feeds TEP
(forage, fodder, straw
and hay) Group
- Alfalfa seed EP
Miscellaneous Commodities
Yes
Yes
Yes
No
plantains )
00044422
00038908 00108203
00040086 00122715
00044426
00076805 00108147
00076805 00108174
NoW
- Aceroia >z/
- Asparagus
- Avocados
- Bananas (including
TEP
TEP
TEP
Partially
Yes
Yes
00108144
00108149
00108175
Yes
No
No
18 Months
18 Months
62
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
Data Requirement Test
Substance
§158.125 Residue Chemistry - Continued
- Coconut54/
- Coffee TEP
- Cotton TEP
- Cotton forage and hay5"/
- Figs57/
- Guava TEP
- Kiwi Fruit58/
- Mangos TEP
- Okra TEP
- Olives, processed EP
- Olive oil EP
- Palm Oils EP
- Papayas TEP
- Peanuts TEP
- Peanut forage and hay TEP
Does EPA
Have Data?1
Partially
Yes
Yes
No
No
Partially
Partially
Yes
Yes
Partially
Partially
Bibliographic
Citation1
00051980
00060103 00108153
00061553 00108203
00108176
00059050
00108175
00108175
GS01 78-028
00063713
00028852
00028852
Must Additional Timeframe
Data be for
Submitted? Submission
Yes55/ 18 Months
No
No
Yes59/ 18 Months
No^/
Yes61/ 24 Months
Yes61/ 24 Months
No
No
Yes62/ 18 Months
Yes^2/ 18 Months
63
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
Data Requirement
§158.125 Residue Chemistry -
- Peanut hulls
- Peanut meal
- Peanut soaps tock
- Peanut oil (crude and
refined)
- Pineapple
- Pineapple forage
- Pistachio nuts
- Sugarcane
- Sugarcane forage
- Sugarcane mollasses
- Tea
- Instant tea
Test
Substance
Continued
TEP
EP
EP
EP
TEP
TEP
TEP
TEP
TEP
EP
EP
EP
Does EPA
Have Data?1
Partially
No
No
No
No
No
Yes
Partially
No
Yes
Partially
Partially
Bibliographic
Citation1
00028852
00111945
00027235
00108140
00108168
00027235
00108140
00108168
00078823
00078824
00078823
00078824
Must Additional
Data be
Submitted?
Yes62/
Yes63/
Yes63/
Yes"/
NoW
Yes^V
No
Yes66/
Yes66/
No6^/
Yes68/
Yes68/
Timef rame
for
Submission
1 8 Months
24 Months
24 Months
24 Months
18 Months
18 Months
18 Months
24 Months
24 Months
- Watercress
TEP
No
64
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
Data Requirement
Test
Substance
Does EPA
Have Data?1
§158.125 Residue Chemistry - Continued
Magnitude of the Residue
in Plants Resulting from
the Use of Irrigation
Water
EP
Partially
Magnitude of the Residue
in Meat, Milk, Poultry, Eggs,
Fish, and Shellfish
- Cattle, Goats, Hogs, TGAI Partially
Horses, Poultry, and or Plant
Sheep Metabolites
- Fish and Shellfish EP Partially
Nature and Magnitude of the EP Yes
Residue in Drinking and
Irrigation Water
Bibliographic
Citation1
Must Additional
Data be
Submitted?
Timeframe
for
Submission
00039381
Yes70/71/ 18 Months
00108115
00036229
00076491
00039377
00039381
00077227
00077228
00077229
00077230
00077231
00077232
00077233
00077234
00077235
00077236
00077237
00077238
00077301
00108173
65
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
§158.125 Residue Chemistry - Footnotes
\J Metabolism studies utilizing ruminants and poultry are required. Animals must be dosed for 3 days with
N-phosphonomethyl 14C glycine at a concentration in the total diet which will result in sufficient residues
in the tissues, milk, and eggs for characterization. Animals must be sacrificed within 24 hours of the final dose
(milk and eggs must be collected twice daily.) The distribution, characterization, and quantification of residues
must be determined in eggs, milk, muscle, fat, kidney, and liver. The samples from these studies must be analyzed
by enforcement methods to ascertain that all metabolites of concern are adequately determined.
2/ The HLPC procedure that has undergone a successful method tryout, should be published in the PAM, Vol. II and a
statement should be inserted in Method I (GLC) of the PAM, Vol II that discourages its use due to the lengthiness
of the pro«_eJure.
_3_/ This crop group tolerance is not appropriate and should be deleted for the following reasons.
0 Residue data are required for an additional commodity (radishes).
0 The use pattern is much different for parsnips and rutabagas (wiper applications) and for turnips (spot treatment
for site preparation) than for other root crops (preemergence or preplant). Should a new crop group tolerance be
sought these group members should be deleted.
_4/ The available data support the group tolerance of 0.2 part per million (ppm); however, individual tolerances
should be established because the group in which the commodity is included is obsolete or the requirement for the
appropriate current crop group should be satisfied.
5/ Residues must be determined in granules, chips, and dried potatoes processed from tubers bearing measurable
residues. Exaggerated application rates may be necessary to achieve measurable residues. If residues are found
to concentrate in any of these processed commodities, appropriate food addditive tolerances must be proposed.
&J The requested data for parsnips will be upon their receipt, translated to rutabagas and based in these data, a
separate tolerance should be established for rutabagas since the root crop vegetable group in which rutabagas was
included is now obsolete.
TJ Residues of glyphosate and AMPA in or on parsnips harvested 14 days following two wiper applications made in
opposite directions on the same day with 3 pound active ingredient/gallon (Ib ai/gal) SC/L formulation using (in
separate tests) roller and wick devices are required. One gal product in 10 gal solution must be auplied by roller
and one gallon product in 3 gal of solution must be applied by wick. Tests must be conducted in CA, IL, and PA or
NY. These data will be translated to rutabagas.
66
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
§158.125 Residue Chemistry - Footnotes (cont'd)
8/ Residues mast be determined in dehydrated pulp, molasses, and refined sugar processed from sugar beets bearing
measurable weathered residues. Exaggerated application rates may be necessary to achieve measurable residues.
If residues are found to concentrate in any of these processed commodities, appropriate food/feed additive
tolerances will be needed.
9/ Residues of glyphosate and its metabolites AMPA in or on turnips following two preplant treatments with the 0.96%
RTU (0.72% ai) formulation sprayed directly on undesirable foliage to the point just before the spray begins to
drip or run are required. A separate tolerance, based on the results of the requested data, be established for
residues in or on turnips since the root crops vegetables group in which turnips was included is now obsolete.
1O/ A crop group tolerance is not appropriate at the present time for the following reasons:
0 Residue data are required for one additional group member (turnip tops); residue data for only one group member
(sugar beet tops) are available.
0 The use pattern is much different for turnips (spot treatment for site preparation) than for sugar beets, chicory,
and garden beets (preemergence or preplant). Should a new crop tolerance be sought, turnips should be excluded.
11/ Based on data from other vegetables and root crops a separate tolerance of 0.2 ppm should be established for
residues in or on this commodity since the leafy vegetables group in which the commodity was included is obsolete.
12/ Residues of glyphosate and its metabolite AMPA in or on turnip greens following two preplant treatments with
0.96% RTU (0.72% ai) formulation directed on underside foliage to the point just before the spray begins to drip or
run off foliage are required.
13/ A crop group tolerance is not appropriate at the present time for the following reason:
0 No residue data have been presented for any member of this group. In order to satisfy minimum data requirements,
data should be submitted for onions (green and bulb) and either garlic, leeks, or shallots.
14/ Since the root crop vegetable group in which this commodity was included is obsolete and no data are available
to support the established 0.2 ppm tolerance on onions a separate tolerance must be established. The following
additional residue data are required:
0 Combined residues of glyphosate and AMPA in or on onions (bulb and green) following preemergence applications
with the 3 Ib ai/gal SC/L formulation totaling 6 Ib ai/A (the final application must be at 3.75 Ib ai/A) in
the states of CA and TX for spring onions and the states of CA and NY for dry bulb onions.
67
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
§158.125 Residue Chemistry - Footnotes (cont'd)
15/ A group tolerance is not appropriate at this time because no residue data have been submitted for celery and
spinach. The following data are required if a crop group tolerance is desired:
0 Data depicting combined residues of glyphosate and AMPA in or on celery following preemergence applications
with 3 Ib ai/gal SC/L formulation totaling 6 Ib ai/A (with the final application at 3.75 Ib ai/A). Separate
tests must be conducted utilizing high and low volume equipment. Tests must be conducted in CA.
0 Data depicting combined residues of glyphosates and AMPA in or on spinach following preemergence applications
with the 3 Ib ai/gal SC/L formulation totaling 6 Ib ai/A (with the final application at 3.75 Ib ai/A).
Separate tests must be conducted utilizing both high and low volume ground equipment. Tests must be conducted
in CA.
16/ The CFR will be amended by deletion of now obsolete leafy vegetable crop group and separate tolerances of 0.2 ppm
should be established for glyphosate residues in or on lettuce, spinach, and celery.
1 ?/ No data are available for celery, but based on the large amount of data available for various vegetable and root
crops, we find the 0.2 ppm tolerances adequate.
18/ No data are available for spinach, but based on the large amount of data available for various vegetable and root
crops we find the 0.2 ppm tolerance adequate.
19/ A crop group tolerance is not appropriate because no residue da'ta have been presented for broccoli and mustard
green, which are representative commodities of this group. The" following data are needed if a crop group
tolerance is desired:
0 Combined residues of glyphosate and AMPA in or on mustard greens following preemergence applications with the
3 Ib ai/gal SC/L formulation totaling 6 Ib ai/A (the final application must be at 3.75 Ib ai/A). Separate
tests must be conducted utilizing both high and low volume ground equipment.
0 A use on broccoli must be proposed and residue data reflecting the proposed use must be submitted.
20/ A separate tolerance of 0.2 ppm should be established since the tolerance was established as a member of the leafy
vegetable group now obsolete. Alternatively, the appropriate crop group tolerance could be sought upon completion
of the requirements.
21/ No data are available for cauliflower; however, based on the large amount of data available for various vegetable
and root crops, we find the 0.2 ppm tolerance adequate.
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
§158.125 Residue Chemistry - Continued
22/ No data are available for kale; however, based on the large amount of data available for various vegetable and root
crops, we find the 0.2 ppm tolerance adequate.
23/ No data are available for mustard greens; however, based on the large amount of data available for various vegetable
and root crops, we find the 0.2 ppm tolerance adequate.
24/ A group tolerance of 0.2 ppm should be established for the combined residues of glyphosate and AMPA in or on legume
vegetables except soybeans. Soybeans must be excluded from the crop group tolerance for the following reasons:
0 The established 6 ppm for residues in or on soybeans differs from the 0.2 ppm tolerance for residues in or on
other legumes by a factor greater than > 5.
0 The use pattern for soybeans (postemergence and spot treatment) is much different than for other legumes
(preemergence treatment only).
25/ A separate tolerance of 0.2 ppm should be established for legume vegetables except soybeans, since the seed and pod
vegetable group in which these commodities were included is now obsolete.
26/ The following additional data are required to determine whether residues concentrate from processed soybeans
to soapstock:
0 Data depicting residues on soapstock processed from soybeans bearing measurable, weathered residues. If residues
concentrate in soapstock, a feed additive tolerance must be proposed.
27/ A crop group tolerance should be established for the combined residues of glyphosate and AMPA in or on the foliage
of legume vegetables, except soybean forage and hay. Soybean forage and hay must be excluded from the crop group
tolerance for the following reasons:
0 The established tolerances for residues in or on soybean forage and soybean hay (15 ppm) differ from the 0.2 ppm
tolerance for residues in or on forage and hay of other legumes by a factor > 5.
0 The use pattern for soybeans (postemergence spot and directed treatment) is much different than f>»r other legumes
(preemergence treatment only).
28/ A separate tolerance of 0.2 ppm be established for residues in or on the foliage of legume vegetables, except
soybeans, since the seed and pod vegetables group in which these commodities were inc]uded is now obsolete.
69
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
§158.125 Residue Chemistry - Footnotes (cont'd)
29/ A crop group tolerance is not appropriate at the present time because residue data for members of the fruiting
vegetables (except cucurbits) group are currently under review.
30/ A crop group tolerance is not appropriate at the present time because residue data for members of the cucurbit
vegetable group are currently under review.
31 / Data are inadequate to support the citrus fruits group tolerance or a feed additive tolerance for dried citrus
pulp. The following data are required on whole citrus fruit:
0 Data depicting residues of glyphosate in or on whole grapefruit, lemons, and oranges harvested 14 clays after
the last of three applications of glyphosate at 3-4 month intervals (combined total application > 7.95 Ib ai/A/yr)
are required. Tests must be conducted in CA, FL, and TX. Alternatively you may clarify the calculation used
to derive whole fruit residues from juice and peel fraction residues submitted under Pesticide Petition
No. 6G1734.
0 Data concerning residues from whole citrus fruit are required before concentration factors can be determined
for processed citrus fractions (dried pulp, juice, molasses, oil).
32/ The data are insufficient to assess the 0.2 ppm tolerance for residues of glyphosate on stone fruits because data
were not submitted on peaches, nectarines, or apricots harvested at the established 14-day PHI. The following
additional data are required:
0 Residues of concern in or on sweet or sour cherries, peaches, and plums or fresh prunes (representative
commodities) harvested 14 days after the last of multiple applications with the 3 Ib ai/gal SC/L (the final
treatemnt at 3.75 Ibs ai/A) totaling 7.95 Ib ai/A. Tests on sour cherries must be conducted in MI; tests on
sweet cherries must be conducted in MI; tests on plums or fresh prunes must be conducted in CA, OR, WA, and MI,
and tests on peaches must be conducted in CA, SC, or GA, NJ,or PA. Applications are to be made using any
appropriate method specified for these states in the label directions.
33/ Insufficient data were submitted to evaluate the concentration of residues in prunes processed from plums. The
following additional data are required:
0 Processing data from prunes derived from plums bearing measurable, weathered residues. If residues are found
to concentrate in dried prunes,^Jthen an appropriate food additive tolerance must be proposed.
70
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
§158.125 Residue Chemistry - Footnotes (cont'd)
34/ Establishment of a crop group tolerance for small fruits and berries is not appropriate at the present time for
the following reasons:
a. Data in support of a proposed tolerance for combined residues of glyphosate and the metabolite AMPA in or on
small fruits (blueberries, blackberries, raspberries, and strawberries) are currently under review.
b. Additional data are required to support the established tolerance for residues in or on cranberries.
35/ No tolerance has been established for this commodity. A tolerance of 0.2 ppm has been proposed for crop group
small fruits. These data are still under review and the adequacy of the proposed tolerance will not be addressed.
36/ The following additional data are needed to fully assess the established tolerance on cranberries:
° Residue data from tests in MA and WI reflecting wiper application at the maximum allowable concentration of
0.6 Ib ai/gal solution, samples must be collected 30 days after application. These tests must be conducted
in heavily weed-infested bogs, with the equipment operated at a slow ground speed and with the initial appli-
cation in one direction followed by a second application in the opposite direction. Residue data from MA
should reflect both flood- and dry-harvest cranberries.
37/ The following additional data are needed to determine whether food/feed additive tolerances are required for
processed products of grapes:
0 Data depicting residues in or on wet and dry pomace, raisin waste, and juice processed from grapes bearing
measurable weathered residues. It may be necessary to treat with exaggerated rates to obtain measurable residues
in the raw agricultural commodity. If concentration occurs, appropriate food/feed additive tolerances must be
proposed.
38/ The established crop group tolerance for glyphosate residues in or on grain crops is not appropriate and should be
deleted for the following reasons:
0 The use pattern for rice (preemergence) is much different than for other grain crops (preemergenco and post-
emergence ).
0 State labels [24(c) registrations] permit postemergence wiper applications on soryhum grown in KS, MO, NE, NM,
OK and TX and section 18 wheat grown in ID, OK, OR, and WA; the available data show that this application method
may result in residues in or on sorghum and wheat grain in excess of the established 0.1 ppm tolerance.
0 A tolerance increase for residues in or on wheat grain (but no other commodities in this group) has been proposed
and these data are currently under review. 7 1
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
§158.125 Residue Chemistry - Continued
39/ A separate tolerance of 0.1 ppm must be established for residues on this commodity because a group tolerance for
grain crops is not appropriate at the present time.
40/ No additional data are needed because similar data requirements exist for wheat-milled products which, upon their
receipt, will be translated to barley milled products.
41/ The following additional data are needed to determine whether concentration of residues occurs in the processed
products of field corn grain:
0 Field corn grain bearing detectable weathered residues of glyphosate must be processed into oil (crude and
refined) and milled products; residues of glyphosate per se and AMPA in these products must be sought.
exaggerated rates may be necessary to obtain detectable residues in or on grain. If residues concentrate in
any of these processed products, appropriate food additive tolerances must be proposed.
42/ Additional data are not required for this topic because similar data requirements exist for wheat milled products
which, upon their receipt, will be translated to oat milled products.
43/ Wiper application data reflecting the 14-day PHI should be submitted and an appropriate tolerance for glyhphosate
residues in or on sorghum grain following postemergence treatments using wiper devices must be proposed. Otherwise,
the following active existing 24(c) registrations must be cancelled KS 820001, MO 820014, NE 820009, NM 820001,
OK 820010, and TX 820023 must be canceled.
44/ The following additional data are required to determine whether concentration of residues occurs in processed
products of grain sorghum:
0 Sorghum grain bearing detectable weathered residues of glyphosate must be processed into flour and milled
products; residues of glyphosate per se and AMPA in these products must be sought. Exaggerated rates may be
necessary to obtain detectable residues in or on grain. If residues concentrate in any of these processed
products, appropriate food additive tolerances must be proposed.
45/ The following additional data are required to determine whether concentration of residues occur in processed
products of wheat grain:
0 Wheat grain bearing detectable weathered residues of glyphosate must be processed into milled products,
and residues of glyphosate per se and AMPA in these products must be sought. Exaggerated rates may be necessary
to obtain detectable residues in or on grain. If residues concentrate in any of these processed pi jducts,
appropriate food additive tolerances must be proposed.
72
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
§158.125 Residue Chemistry - Footnotes (cont'd)
46/ A crop group tolerance is not appropriate at the present time for the following reasons:
0 The use pattern for rice (preemergence) is much different than for other grain crops (preemergence and post-
emergence ) .
0 State labels [24(c) registrations] permit postemergence wiper applications on sorghum in KS, MO, NE, NM, OK,
and TX. The available data show that this application method may result in residues in or on sorghum forage
in excess of the established 0.2 ppm tolerance (forage grasses group).
47/ Separate tolerances of 0.2 ppm should be established for residues in or on these commodities because a group
tolerance for forage grasses is not appropriate at the present time.
48/ The existing 24(c) registrations (KS 820001, MO 820014, NE 820009, NM 8200001, OK 820010, and TX 820023) must be
cancelled or you could submit data depicting residues 14 days after wiper applications at maximum registered rates
and propose appropriate tolerances for glyphosate residues in or on sorghum forage, fodder, hay, and silage.
49/ Separate crop group tolerances of 100 ppm should be established for residues in or on grass forage and hay. All
the established tolerances for residues in or on grasses, including "forage grasses'1 and "grasses, forage" should
be deleted.
50/ The existing, conflicting tolerances on alfalfa, clover, and forage legumes should be deleted. Separate tolerances
for residues of glyphosate and AMPA of 100 ppm should be established for residues of forage and hay of nongrass
animal feeds.
51 / The following data are required to determine whether a food additive tolerance must be proposed for residues in or
on alfalfa seed:
0 Data depicting residues in or on alfalfa seed from alfalfa hay bearing measurable weathered residues. If the
concentration of residues in seed is higher than in hay, an appropriate feed additive tolerance must be proposed.
52/ The data supporting this tolerance are currently under review, therefore a conclusion on the adequacy of this
tolerance will not be made at this time.
53/ Residue data from green asparagus_harvested 8-15 days following the last two preemergent broadcast applications
are required. The first treatment must be made at 2.25 Ib ai/A and the last at 3.75 Ib ai/A to tot.il 6 Ib ai/A.
Test sites should include the Sacramento/San Joaquin River delta of CA, MI, and MD or NJ.
73
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GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
TABLE A
§158.125 Residue Chemistry - Footnotes (cont'd)
54/ The available data supporting the proposed tolerance for glyphosate residues in or on coconut are currently under
review, therefore, a conclusion regarding the adequacy of the proposed tolerance will not be made at this time.
55/ Residue data must be submitted of concern in or on coffee beans harvested at 14 days after the last of multiple
directed spray applications with the 3 Ib ai/gal SC/L totaling 7.95 Ib ai/A. Tests must be conducted in HI,
Brazil, Columbia, El Salvador, and Mexico.
56/ The established tolerances for residues in or on cotton forage and hay are inappropriate and should be cancelled
since hay is not considered to be a raw agricultural commodity of cotton and feeding and grazing restrictions
exist.
57/ The available data in support of the proposed tolerance for glyphosate residues in or on figs are currently
under review, therefore, a conclusion regarding the adequacy of the proposed tolerance will not be made at this
time.
58/ The available data in support of the proposed tolerance for glyphosate residues in or on kiwi fruit are currently
under review; therefore, a conclusion regarding the adequacy of the proposed tolerance will not be made at this
time.
59/ No residue data for glyphosate in or on mangos were submitted to support the established tolerance. The following
data are required:
0 Data depicting residues in or on mangos harvested 14 days after the last of two directed-spray applications at
3.75 Ib ai/A. Test must be conducted in FL.
60/ No data are available concerning residues in okra. However, based on the large amount of data available for various
vegetables and root crops, we find a 0.2 ppm tolerance adequate.
61/ The following additional documentation and data are required:
0 Documentation that the approved labels (use directions) from Greece, Italy and Spain reflect the data submitted
in PP#9F2223/FAP#OH5255 (a maximum, single application rate of 3.8 Ib ai/A or multiple applications at lesser
rates but with the total of all annual applications not to exceed 3.8 Ib ai/A). The labeled preharvest interval
should not be less than 21 daysv If the labels do not reflect these data, you may revise the labels or submit
additional residue data to adequately support the amount labeled. If the latter, we recommend data be generated
from processed olives from Spain and processed olive oil from Italy and Spain.
0 Documentation of the olive-curing process described as "The standard commercialization procedure t'or table
olives" in PP#9F2223/FAP#OH5255. ~7 A
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GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
§156.125 Residue Chemistry - Footnotes (cont'd)
62/ The following additional data are required on peanut nutmeats, forage, hay, and hulls to assess the appropropriate-
ness of the established tolerances:
0 Data depicting residues in or on nutmeats, forage, hay, and hulls sampled 60 days after a spot treatment at
6 Ib ai/A (0.15 Ib ai/gal solution). Samples must be collected in and at the edge of treated areas. Tests must
be conducted in VA, GA, and TX.
63/ The following processing data are required:
0 Data depicting residues in or on meal, soapstock, and crude and refined oil processed from nutmeats bearing
measurable weathered residues. If residues concentrate in any of these processed commodities, appropriate
food/feed additive tolerances must be proposed.
64/ No data were submitted to support the request for a tolerance for glyphosate residues in or on pineapple. Based
on the built-in 21-month PHI (interval from intercycle, fallow period to harvest of mature fruit), v/e defer the
requirement for residue data for fruit.
65/ Since forage of pineapple is considered a food item, the following are required:
0 A feeding and grazing restriction for pineapple forage. Alternatively, you may submit tests from HI reflecting
residues in or on forage harvested 8 weeks after the last of two preplant broadcast applications at 2.25 and
3.75 Ib ai/A, respectively, and propose an appropriate tolerance.
66/ The following additional data are required on sugarcane and sugarcane forage:
0 Data depicting residues in or on cane harvested on the day of a postemergence. Directed spray application must
be applied at 6-15 Ib ai/100 gal (7.95 Ib ai/A) and in or on forage harvested 8 weeks after treatment. Tests
must be conducted in LA and FL. A tolerance must be proposed for residues in or on forage and an appropriate
tolerance revision must be proposed for residues in or on cane. Alternatively, a grazing restriction may be
proposed and no forage data submitted.
67/ The established tolerance on molasses appears adequate at present, but will be reevaluated on receipt of data
requested for cane.
75
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
§158.125 Residue Chemistry - Footnotes (cont'd)
68/ The following additional data are required to fully assess the adequacy of food additive tolerances for imported
dried tea:
0 Reaffirmation of foreign distribution of glyphosate for use on tea plantations.
0 Documentation of label directions from all countries in which glyphosate is registered for this use.
We recommend that a 7 ppm food additive tolerance revision for instant tea be made to sufficiently cover the
5-7X processing concentration factor.
69/ No data are available to support the established tolerance for residues in or on watercress. Based on the large
amount of data available for vegetable and root crop vegetables a 0.2 ppm tolerance is adequate for watercress.
70/ The following data are required:
0 Data must be submitted reflecting sprinkler irrigation of crops with natural waters which have been treated with
gyphosate to control severe aquatic weed infestations. The protocol should include irrigation of several foliar
crops such as corn (forage), alfalfa, grasses, and a leafy vegetable treated with water from large impounded
bodies of water and rivers.
71/ The tolerances established for the currently obsolete crop groupings should be deleted and tolerances for residues
in or on all crop groups in the currently accepted crop grouping scheme and all major irrigated crops not included
in a crop group (cotton, sugarcane, peanuts, etc.) be established at a level consistent with data resulting from
the protocol requested.
72/ Presently, the nature and storage stability of residues in ruminants (including milk) and poultry (including eggs)
are not adequately understood. Additional residue data are required for raw agricultural commodities and processed
commodities. Once the requested data are received, the adequacy of the available data and established tolerances
will be assessed.
73/ Insufficient data are available to ascertain the nature of residues in natural waters. Therefore, we will defer an
opinion as to the adequacy of available data and established tolerances until the requested data are received.
The proposed tolerance on shellfish will not be evaluated because the data supporting this tolerance are currently
under review.
74/ If aquatic metabolism data requested by Exposure Assessment Branch indicate the presence of additional degradates
of toxicological concern in natural waters following treatment with glyphosate, additional residue data depicting
the levels of such degradates in natural water following registered use will be required. A restriction prohibiting
use of treated pond water for irrigation purposes within 24 hours of^ treatment must be placed on th<-- label.
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
Data Requirement Test
Substance
Use
Patterns
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Timeframe
for
Submission
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis
Photodegradation
161-2 - In water
161-3 - On soil
161-4 - In Air
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
MOBILITY STUDIES:
163-1 - Leaching and
Adsorption/Desorption
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
TGAI or PAIRA A,B,C,D,
F,G,H
Yes
TGAI or PAIRA A,B,C,D,G No
TGAI or PAIRA A,G No
TGAI or PAIRA A,F No
TGAI or PAIRA A,B,F,G,H No
TGAI or PAIRA A No
TGAI or PAIRA C,D No
TGAI or PAIRA C,D No
TGAI or PAIRA A,B,C,D Partially
TEP
TEP
A,F
A,F
No
No
0010819;
Yes
Yes
Yes
Yes
Yes1/
Yes
Yes
9
9
9
27
27
27
27
Months
Months
Months
Months
Months
Months
Months
00108192
Yes
Yes
Yes2/
12 Months
12 Months
15 Months
77
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
Data Requirement Test
Substance
§158.130 Environmental Fate - Continued
DISSIPATION STUDIES-FIELD:
164-1 - Soil TEP
164-2 - Aquatic (Sediment) TEP
164-3 - Forestry TEP
164-4 - Combination and
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
Use Does EPA Bibliographic Must Additional Timeframe
Patterns Have Data? Citation Data be for
Submitted? Submission
A,B,H No Yes 27 Months
C,D No Yes 27 Months
G No Yes 27 Months
A,C No Yes3/ 50 Months
A,C No Yes 39 Months
A,C No Yes 50 Months
C,D No Yes 39 Months
A,B,C, No Yes 12 Months
D,G
A,B,C No Yes 12 Months
D,G
Subpart K Re-entry
TEP4/
78
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
§158.130 Environmental Fate - Footnotes
1/ Not required if an acceptable anaerobic aquatic metabolism study is conducted.
2/ Deferred pending receipt of acceptable laboratory volatility data.
3/ Requirement is contingent upon results of studies in 162-1 and/or studies in 164-1 and 164-2,
4/ No data required because of low toxicity and exposure from present use patterns.
79
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
Data Requirement Test
Substance
§158.1
ACUTE
81-1 -
81-2 -
81-3 -
81-7 -
35 Toxicology
TESTING:
Acute Oral Toxicity - Rat TGAI
Acute Dermal Toxicity TGAI
- Rabbit
Acute Inhalation Toxicity TGAI
- Rat
Delayed Neurotoxicity TGAI
- Hen
Use Does EPA Bibliographic Must Additional Timeframe
Patterns Have Data? Citation Data be for
Submitted? Submission
A,B,C,D, Yes 00067039 No
F,G,H
A,B,C,D, Yes 00067039 No
F.G,H
A,B,C,D, No Yes 9 Months
F,G,H
A , B , C , D , No No 1 /
F,G,H
SUBCHRONIC TESTING:
82-1 -
82-2 -
82-3 -
82-4 -
90-Day Feeding: TGAI
- Rodent
- Non-rodent (dog)
21 -Day Dermal - Rabbit TGAI
90-Day Dermal - Rabbit TGAI
90-Day Inhalation -TGAI
- Rat
A,B,C,D, No No2/
F,G,H
A,B,C,D, No No2/
F,G,H
A,B,C,D, Yes 00098460 No
F,G,H,
A,B,C,D, No No3/
F,G,H ~
A,B,C,D, No No4/
F,G,H ~
80
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
Data
Requirement
Test Use Does EPA
Substance Patterns Have Data?
Bibliographic Must Additional Timeframe
Citation Data be for
Submitted? Submission
§158.135 Toxicology - Continued
82-5 -
CHRONIC
83-1 -
83-2 -
83-3 -
90-Day Neurotoxicity :
- Hen
- Mammal
TESTING:
Chronic Toxicity -
2 species
- Rodent
- Non-rodent (dog)
Oncogenicity -
2 species
- Rat (preferred)
- Mouse (preferred)
Teratogenicity -
2 Species
- Rat
- Rabbit
TGAI A,B,C,D, No
F,G,H-
A,B,C,D, No
F,G,H
i
TGAI
A,C,D, Yes
F,H
A,C,D, Partially
F,H
TGAI
A,C,D, Partially
F,H
A,C,D, Partially
F,H
TGAI
A,B,C,D, Yes
F,G,H
A,B,C,D, Yes
F,G,H
NoV
NoV
00093879 No
00153374 Yes6/ 50 Months
00093879 Yes7/ 50 Months
00130406 Yes8/ 50 Months
00046362 No
00046363 No
81
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
Data Requirement
§158.135 Toxicology - Continued
83-4 - Reproduction - Rat
2-generation
MUTAGENICITY TESTING:
84-2 - Gene Mutation (Ames Test)
84-2 - Structural Chromosomal
Aberration
84-4 - Other Genotoxic Effects
SPECIAL TESTING:
85-1 - General Metabolism
85-2 - Dermal Penetration
86-1 - Domestic Animal Safety
Test Use Does EPA
Substance Patterns Have Data?
TGAI A,C,D,H Yes
TGAI A,B,C,D Yes
F,G,H
TGAI A,B,C,D, Yes
F,G,H
TGAI A,B,C,D, Yes
F,G,H
PAI or A,C,D No
PAIRA F , G , H
Choice N/A9/
Choice H No
Bibliographic Must Additional Timeframe
Citation Data be for
Submitted? Submission
00081674 No
00105995
00078620 No
00132683
00046364 No
00132681
00132685
00078619 No
00132686
Yes 24 Months
No
No1''/
82
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
§158.135 Toxicology - Footnotes
\J Glyphosate is not an organophosphate insecticide or carbamate; therefore, this test is not required.
2/ These studies are not required because the one year dog and chronic rat study will fulfill these requirements.
3/ This study is not required because the use pattern does not indicate a potential for purposeful dermal application
or prolonged contact.
4/ This study is not required because the use pattern does not indicate a potential for repeated inhalation exposure
at concentrations likely to be toxic.
SJ These studies are not required because glyphosate is not an organophosate insecticide or carbamate and there is no
evidence of neurotoxicity or neuropathy in any of the submitted studies.
_6/ Additional data is required to address findings in this study.
T_/ A repeat rat study is required in which the highest dose tested is a maximally tolerated dose (MTD).
8/ A repeat mouse study is required. A protocol should be submitted prior to initiation of a new study.
9/ N/A = Not applicable for the purpose of this standard.
10/ It is unlikely that a hazard to domestic animals exist as a result of this use; therefore the test is not required,
83
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
Data Requirement
§158.140 Reentry Protection
132-1 - Foliar Dissipation
132-1 - Soil Dissipation
133-3 - Dermal Exposure
133-4 - Inhalation Exposure
§158.142 Spray Drift
201-1 - Droplet Size Spectrum
201-1 - Drift Field Evaluation
Special Tests
Test Use Does EPA
Substance Patterns Have Data?
TEP N./A 1 /
TEP N/A
TEP N/A
TEP N/A
TEP N/A
TEP N/A
Bibliographic Must Additional
Citation Data be
Submitted?
No
No
No
No
No
No
Time frame
for
Submission
\J N/A = not applicable for the purposes of this Standard.
84
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
Data Requirement
§158.145 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
Test Use Does EPA
Substance Patterns Have Data?
Bibliographic Must Additional Timeframe
Citation Data be for
Submitted? Submission
71-1 - Acute Avian Oral Toxicity
71-2 - Avian Subacute Dietary
Toxicity
- Upland game bird
- Waterfowl
71-3 - Wild Mammal Toxicity
71-4 - Avian Reproduction
- Upland game bird
- Waterfowl
71-5 - Simulated Field Testing
- Mammals
- Birds
TGAI
TGAI
TGAI
TGAI
TEP
A,B,C,D
F,G,H
A,B,C,D,
F,G,H
A,B,C,D,
F,G,H
A,B,C,D
F,G,H
A,B,C,
D,G
A,B,C,
D,G
A,B,C,
D,G
A,B,C,
D,G
Yes
00108204
No
Yes
1/2/
Yes
No
Yes*/
Yes
No
No
00108107
00076492
00076492
00108207
00036328
00111953
No
No
No
No
No5/
No5/
85
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
Data
Requirement
Test Use Does EPA Bibliographic Must Additional
Substance Patterns Have Data? Citation Data be
Submitted?
Timef rame
for
Submission
§158.145 Wildlife and
Aquatic
—
AQUATIC
72-1 -
Organisms - Continued
Actual Field Testing
- Mammals
- Birds
ORGANISM TESTING
Freshwater F^.sh Toxicity
- Coldwater fish species
- Warmwater fish species
TEP
A,B,C, No NoV
D,G
A,B,C, No No5/
D,G
TGAI A,B,C,D Yes1/2/ 00136339 No
F,G,H GS0178-025
A,B,C,D, Yes 00108112 No
F,G,H 00108205
TEPV A,B,C, Yes6/ 00070895 00078661 No
D,G 00070897 00078662
72-2 - Acute Toxicity to
Freshwater Invertebrates
TGAI
TEP4/
A,B,C,D,
F,G,H
A,B,C,
D,G
Yes
Yes6/
86
00078655 00078664
00078656 00078665
00078658 00108205
00078659 00124760
GS0178-025
00108172
00070893 00078666
00078657 00124762
00078660 GS0178-025
00078663
No
No
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
Data Requirement
Test
Substance
Use
Patterns
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Timeframe
for
Submission
§158.145 Wildlife and
Aquatic Organisms - Continued
72-3 - Acute Toxicity to Estuarine
and Marine Organisms
- Fish TGAI
- Mollusk TGAI
- Shrimp TGAI
72-4 - Fish Early Life Stage TGAI
- Aquatic Invertebrate
Life Cycle
72-5 - Fish Life Cycle TGAI
72-6 - Aquatic Organism
Accumulation
Crustacean
Fish
Insect Nymph
Mollusk
TGAI, PAI or
Degradation
Product
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,D
G,H
A,B,C,D,
G,H
N/A^/
N/A1°/
Partially^/
YesV
No
Yes
Yes
No
No
No
No
00108110
00108111
00124763
00108171
No8/
No
No
No
No
No
No
No
No
87
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
Data
Requirement
Test Use Does EPA Bibliographic Must Additional
Substance Patterns Have Data? Citation Data be
Submitted?
Time frame
for
Submission
§158.145 Wildlire and
Aquatic
72-7 -
Organisms - Continued
Simulated Field Testing
- Aquatic Organisms
Actual Field Testing
- Aquatic Organism
TEP
N/A No No11/
N/A No No11/
\J Required to support manufacturing use product for reformulation into end use.
_2/ Only one species required.
_3/ These data are required if available acute toxicology data indicate an acute hazard. Available data do not
trigger this requirement.
4_/ Label directions allow for repeat applications.
5/ These data are required if available acute data on birds and mammals indicate an acute hazard. Available
data do not trigger these requirements.
6/ These tests are required when inerts are likely to be toxic.
T_/ These studies are required because of the potential exposure of estuarine species, for application on cotton,
sugarcane, corn, soybeans, ditchbanks and tide areas, and potential hazard to endangered mussels.
_§/ Existing glyphosate data for freshwater and estuarine crustacean plus numerous freshwater fish studies suggest little
toxicity to estuarine fish.
9/ The glyphosate TL50 > 10 mg/L is 2V7 times greater than the amount expected after direct application to a 6-inch-
acre layer of water. Therefore, further testing is not warranted.
10/ N/A = not applicable for purposes of this standard.
11/ These studies are required if available acute toxicity data on gjgatic organisms indicate an acute hazard.
Available data do not trigger these requirements.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
Data
§158.150
121-1 -
Requirement
Plant Protection
TARGET AREA
PHYTOTOXICITY
Test Use Does EPA Bibliographic Must Additional
Substance Patterns Have Data? Citation Data be
Submitted?
TEP B,D,G No No1/
Timef raroe
for
Submission
NONTARGET AREA PHYTOTOXICITY
122-1 -
122-1 -
122-2 -
123-1 -
123-1 -
123-2 -
TIER I
Seed Germination/
Seedling Emergence
Vegetative Vigor
Aquatic Plant Growth
TIER II
Seed Germination/
Seedling Emergence
Vegetative Vigor
Aquatic Plant Growth
TGAI B,D,G No Yes2/
TGAI B,D,G No Yes2/
TGAI B,D,G No Yes2/
TGAI B,D,G No Reserved3/
TGAI B,D,G No Reserved3/
TGAI B,D,G No Reserved3/
9 Months
9 Months
9 Months
89
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TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
1
1
Data Requirement
TIER III
24-1 - Terrestrial Field
24-2 - Aquatic Field
Test Use Does EPA Bibliographic Must Additional
Substance Patterns Have Data? Citation Data be
Submitted?
TEP B,G No Reserved4/
TEP D No Reserved4/
Timeframe
for
Submission
_1_/ Data are required only for Special Review and certain public health situations.
2_/ These studies are required because there is evidence of phytotoxicity problems from application of this pesticide
and open literature data are not available on these tests and because the use of this product may pose hazards
to endangered or threatened species.
3/ These studies are reserved pending results of Tier I testing.
4/ These studies are reserved pending results of Tier II testing if required.
90
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
Data Requirement
158.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS :
141-1 - Honeybee acute
contact toxicity
141-2 - Honeybee - toxicity
of residues on
foliage
141-4 - Honeybee subacute
feeding study
141-5 - Field testing for
pollinators
Test Use Does EPA Bibliographic Must Additional Timeframe
Substance Patterns Have Data? Citation Data be for
Submitted? Submission
TGAI A,B, Yes 00026489 No
G,H
TEP A,B, No No1/
G,H
(Reserved )2/
TEP A,B, No No1/
G,H
NONTARGET INSECT TESTING
AQUATIC INSECTS;
142-1 - Acute toxicity to
aquatic insects
142-2 - Aquatic insect
life-cycle study
142-3 - Simulated or actual
field testing for
aquatic insects
143-1 - NONTARGET INSECT
thru TESTING - PREDATORS
143-3 AND PARASITES
(Reserved)_/
(Reserved )/
(Reserved
(Reserved)-^/
91
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR GLYPHOSATE
§158.155 Nontarget Insect - Footnotes
J_/ As data from the acute study indicate very low toxicity, no further testing is required.
2/ Reserved pending development of test methodology.
JV Reserved pending Agency decision as to whether this data requirement should be established.
92
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING GLYPHOSATE
No
No
NO
N/A
N/A
N/A
Yes
Yes4/
6 Months
6 Months
6 Months
Data Requirement Test Use Does EPA Bibliographic Must Additional Timeframe
Substance Patterns Have Data?1 Citation1 Data be for
Submitted? Submission
§158.120 Product Chemistry
Product Identity;
61-1 - Product Identity and MP
Disclosure of
Ingredients
61-2 - Description of Beginning MP
Materials and Disclosure
of Manufacturing Process
61-3 - Discussion of Formation MP
of Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis MP
62-2 - Certification of Limits MP
62-3 - Analytical Methods to MP
Verify Certified Limit
Physical and Chemical Characteristics
63-2 - Color MP
63-3 - Physical State MP
63-4 - Odor MP
No
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
N/A
YesV 12 Months
Yes^/ 12 Months
YesV 12 Months
Yes 6 Months
Yes 6 Months
Yes 6 Months
93
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING GLYPHOSATE
Data Requirement Test
Substance
§158.120 Product Chemistry - Continued
Physical and Chemical Characteristics
(Continued)
63-7 - Density, Bulk Density, or
Specific Gravity
63-12 - pH
63-14 - Oxidizing or Reducing
Action
63-15 - Flammability
63-16 - Explodability
63-17 - Storage Stability
63-18 - Viscosity
63-19 - Miscibility
63-20 - Corrosion Characteristics
Other Requirements
64-1 - Submittal of samples
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
Use Does EPA Bibliographic
Patterns Have Data?1 Citation1
•
No N/A
No N/A
No N/A
No N/A
No N/A
No N/A
No N/A
No N/A
No N/A
No N/A
Must Additional
Data be
Submitted?
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Timeframe
for
Submission
6 Months
6 Months
6 Months
6 Months
6 Months
15 Month
6 Months
6 Months
15 Months
6 Months
1/ 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 manufacturing-use product. New requirements have been introduced and
previously submitted data must be updated. Therefore bibliographic citations for the old data are not applicable.
94
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING GLYPHOSATE
$158.120 Product Chemistry - Footnotes (cont'd)
2_/ Details of manufacturing process, including the relative amounts of beginning materials, a description of equipment
used to produce the product, reaction conditions, the duration of each step of the process, and purification pro-
cedures and quality control measures for 41.09% ai formulation intermediate (FI), the 53.5% ai FI, the 62% ai FI,
the unregistered technical isopropylamine salt glyphosate used to produce the FI's, and the unregistered technical
trisodium salt are required.
_3_/ The names and addresses of manufacturers, producers,, or suppliers of each beginning material used to manufacture the
41.04% ai FI, the 53% ai FI, the unregistered technical products to produce the FIs and the unregistered trisodium
salt are required. Also, a copy of all available technical specifications, data sheets, and other documents in
which the manufacturer, producer, or supplier of the beginning material describes its composition and properties
must be submitted.
4/ A discussion is required of each impurity believed to be present at 0.1% or greater, based on knowledge of beginning
materials, all possible chemical reactions and any contamination.
j>/ Five or more representative samples of 41.04% ai FI, the 53.5% ai FI, the 62% ai FI, and the unregistered technical
trisodium salt analyzed for the amount of active ingredient and each impurity present at 0.1% (w/w) (including any
nitroso-amines which may be present at~0.1 ppm) are required.
6/ The following additional data are required:
0 Upper and lower limits must be provided and certified for each intentionally added inert in the FI's. Also, the
purpose of each intentionally added inert in EPA Registration Nos. 524-318 and 524-333 must be specified.
0 Upper and lower limits must be provided and certified (FI's only) for each impurity present at 0.1% (w/w) or greate
in the FI's, the unregistered isopropylamine salt technical(s) from which the FI's are produced, and the technical
trisodium salt.
0 Upper and lower limits must be provided and certified (FI's only) for glyphosate in t-.he FI's, the unregistered
technical products from which the FI's are produced, and in the technical trisodium salt.
0 All nitrosoamines must be identified and quantified in six samples each of the registered FI's, the unregistered
technical trisodium salt, and the unregistered technicals from which the FI's are produced; two samples of each
must be analyzed shortly after production, 3 months after production, and 6 months after production. A method
sensitive to 1 ppm on N-nitroso contaminants must be used. An upper limit must be presented and certified
(FI's only) for all nitrosoamines found.
95
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING GLYPHOSATE
§158.120 Product Chemistry - Footnotes (cont'd)
TJ The following additional data are required:
0 Quantitative methods to determine glyphosate and all impurities and intentionally-added inerts for which a
certified limit is required in the 40.04% ai FI, the 53.3% ai FI, and the 62% ai FI. Analytical methods for
glyphosate and impurities at > 0.1% (w/w) are also required for the unregistered technical glyphosate product(s)
used to produce the FI's and the unregistered technical trisodium salt. Each method must be accompanied by
validation studies of the precision and accuracy of the method.
96
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE
PRODUCTS CONTAINING GLYPHOSATE
Data Requirement Test
Substance
§158.
ACUTE
81-1
81-2
81-2
81-4
81-4
81-6
1 35 Toxicology
TESTING
- Acute Oral Toxicity - Rat MP
- Acute Dermal Toxicity MP
- Rabbit
- Acute Inhalation Toxicity MP
- Rat
- Primary Eye Irritation MP
- Rabbit
- Primary Dermal Irritation MP
- Rabbit
- Dermal Sensitization MP
- Guinea Pig
Use Does EPA
Patterns Have Data?
A,B,C,D, Yes
F,G,H
A,B,C,D, Yes
F,G,H
A,B,C,D, No
F,G,H
A,B,C,D, Yes
F,G,H
A,B,C,D, Yes
F,G,H
A,B,C,D,
F,G,H No
Bibliographic Must Additional Timeframe
Citation Data be for
Submitted? Submission
00067039 No
00067039 No
Yes 9 Months
00067039 No
00067039 No
Yes 9 Months
97
-------
II. LABELING.APPENDICES
Summary of label requirements and table
UO CFR 162.10 Labeling Requirements
Physical/Chemicals Hazards Labeling Statements
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
98
-------
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)J
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)]
-------
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
on Front Panel
in Square Inches
5 and under
above 5 to 10
above 10 to 15
above 15 to 30
over 30
Signal Word
Minimum Type Size
All Capitals
6 point
10 point
12 point
14 point
18 point
"Keep Out of Reach
of Children"
Minimum Type Size
6 point
6 point
8 point
10 point
12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The Statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. [40 CFR 162.10(h) ( 1) ( ii) ]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. [40 CFR 162.10 (h)(l)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. [40 CFR 162.10(h) ( 1) ( i) ]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A Statement/
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. [40 CFR 162 .10( h) ( 1) ( iii ) ]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel
[40 CFR 162.10(h)(l)(iii)J
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) ] .
100
-------
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 III
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
i
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.
101
-------
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 162.10(h)(1)(iv) ,
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if specified
in Section I). If use is restricted to certified applicators,
the following statement is required: "For retail sale
to and use only by Certified Applicators or persons
under their direct supervision and only for those uses
covered by the Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
*
i
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 9B [There is no Item 9B].
Item 9C. MISUSE STATEMENT - All products must b^ar 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.
102
-------
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 [There is no Item 10B] .
Item IOC. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item 10D. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[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. ;
103
-------
SUMMARY-6
LABELING REQUIREMENTS OP THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
Ik
B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/ga 1 Ion
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products"'
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center frorit
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
1 fVi A '
1 !—
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
k
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
practical
treatment
Referral
statement
Side/back panel
precautionary
statements
Hazards to
hunans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxic ity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others :
Grouped with
side panel
precau t ionary
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.
105
-------
SUMMARY-8
ITEM
8C
9A
9C
10A
IOC
LOD
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
All
cholinesterase
inhibitors
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front •
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Must be set apart and clearly distin-
guishable from from other directions
for use.
May be in metric as well as U.S. units
106
-------
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.
107
-------
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.
I
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.
-------
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 and
plastic bags
Compressed gas
cylinders
Triple rinse (or equivalent) . Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities .
Triple rinse (or equivalent) . Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Triple rinse (or equivalent) . Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused1, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. if burned, stay
out of smoke .
Return empty cylinder for reuse (or
similar wording)
Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
109
-------
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 (see list in this Appendix) or are assigned to Toxicity Category
I on the basis of oral or dermal toxicity, skin or eye irritation potential,
or Toxicity Category I or II on the basis of acute inhalation toxicity
must bear the following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal of
excess pesticide, spray mixture, or rinsate is a violation of Federal
Law. If these wastes cannot be disposed of by use 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
(see list in this Appendix) 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 domestic
use, must bear the following pesticide disposal statement:
"Wastes resulting from the use of this product may be disposed of on
site or at an approved waste disposal facility."
5. Products intended for domestic use only must bear the following
disposal statement: "Securely wrap original container in several layers
of newspaper and discard in trash."
110
-------
PEST/DIS-2
PESTICIDE ACTIVE INGREDIENTS THAT ARE ACUTE HAZARDOUS WASTES
I. PESTICIDES ON THE "E" LIST (with RCRA # and CAS #
[40 CFR 261.33(e)]
Acrolein
Aldicarb
Aldrin
Allyl alcohol
Aluminum phosphide
4-Minopyridine (Avitrol)
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts
not otherwise specified)
Cyanogen chloride
Dieldrin
0,0-Diethyl S-[2-ethylthio)ethyl]
phosphorodithioate (disulfoton)
0,0-Diethyl 0-pyrazinyl
phosphorothioate (Z inophos®)
Dimethoate
0,0-Ddmethyl 0-p-nitrophenyl
phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclohexylphenol
Dinoseb
Endosulfan
Endothall
Endrin
Famphur
Fluoroacetamide
Heptachlor
Hexachlorohexahydro-exo, exo-
dimethanonaphthalene (Isodrin)
Hydrocyanic acid
Methonyl
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octane thylpyrophosphoramide
(OMPA, schradan)
Parathion
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
POOS
P070
P004
POOS
P006
POOS
P010
P011
P012
P021
P022
P024
P030
P031
P037
P039
P040
107-13-1
116-06-3
309-00-2
107-18-6
1302-45-0
504-24-5
7778-39-4
1303-28-2
1327-53-3
592-01-8
75-15-0
106-47-8
506-77-4
60-57-1
298-04-4
297-97-2
P044
P071
P047
P034
P020
P050
P088
P051
P097
P057
P059
P069
P063
P066
P072
P075
P085
P089
P092
P094
P098
P102
P105
P106
P058
60-51-5
298-00-0
534-52-1
131-89-5
88-85-7
115-29-7
129-67-9
72-20-8
52-85-7
640-19-7
76-48-8
465-73-6
74-90-8
16752-77-5
86-88-41
54-11-5
152-16-9
56-38-2
62-38-4
298-02-2
151-50-8
107-19-7
26628-22-8
143-33-9
62-74-8
111
-------
PEST/DIS-3
Strychnine and salts P108 57-24-9
60-41-3
0,O,0,Oietraethyl P109 3689-24-5
dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate Pill 107-49-3
Thallium sulfate P115 7446-18-6
Thiefanox P045 39196-18-4
Toxaphene P123 8001-35-2
Warfarin (>0.3%) P001 81-81-2
Zinc phosphide (>10%) P122 1314-84-7
50 ACTIVES
F027
F027
F027
F027
F027
5324-22-1
35109-57-0
136-25-4
327-98-0
70-30-4
II. PESTICIDES DERIVED FROM TRI-, TETRA-, AND PENTACHLOROPHENOLS
[40 CFR 261.31]
2-Chlorcethyl 2-(2,4,6-trichloro-
phenoxy) ethyl ether
Dehydroabietylammonium
pentachlorophenoxide
Erbon
0-ethyl O-(2,4,5-trichlorophenyl)
ethylphosphonothioate
2,2'-Methylenebis
(3,4,6-trichlorophenol)
(Hexachlorophene) '
—Potassium salt of
—Sodium salt of
—Discdium salt of
Pentachlorophenol
—Potassium salt of
—Sodium salt of
—Zinc salt of
—Zinc salt of N-alkyl
(C^g-C^g)-l,3-propanediamine
—Pentachlorophenyl laurate
Potassium trichlorophenate (2,4,6)
Potassium trichlorophenate (2,4,5)
Silvex
—2-Butoxyethyl ester
—Butoxypolypropoxypropyl ester
—Butoxypropyl ester
—Diethanolamine salt
—Diisopropanolamine salt
—Dimethylamine salt
—Dipropylene glycol isobutyl
ether ester
—Ethanolamine salt
—2-Ethylhexyl ester
—-Isooctyl ester
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
67923-62-0
3247-34-5
5736-15-2
87-86-5
7778-73-6
131-52-2
2917-32-0
11
3772-94-9
2591-21-1
35471-43-3
93-72-1
19398-13-1
53404-07-2
25537-26-2
51170-59-3
53404-09-4
55617-85-1
53535-26-5
7374-47-2
53404-76-5
£3404-14-1
-------
PEST/DIS-4
—Isopropanolamine salt F027
—Monohydroxylaluminum salt F027
—Polypropoxypropyl ester F027
—Potassion salt F027
—Propylene glycol isobutyl F027
ether ester
—Sodium salt F027
—Triethanolamine salt F027
—Triethylamine salt F027
—Triisopropanolamine salt F027
—Tripropylene glycol isobutyl F027
ether ester
Sodiun 2-(2,4,5-trichlorophenoxy) F027
ethyl sulfate
Tetrachlorophenols F027
—Alkylamine*amine salt (as in F027
fatty acids of coconut oil)
—Potassium salt F027
—Sodium salt F027
2,4,5-Trichlorophenol F027
2,4,6-Trichlorophenol F027
2,4,5-Trichlorophenol salt of F027
2,6-bis [ (dimethylamino)raethyl]
cyclohexanone
2,4,5-Trichlorophenol, sodium salt F027
2,4,6-Trichlorophenol> sodium salt F027
2,4,5-Trichlorophenoxyacetic acid F027
—Alkyl C-12 amine salt F027
--Alkyl C-13 amine salt F027
—Alkyl C-14 amine salt F027
—N,N-diethylethanolamine salt F027
—Dimethylamine salt F027
—N,N-dimethyllinoleylamine salt F027
—N,N-dimethyloleylamine salt F027
—N-oleyl-1,3-propylene FO 27
diamine salt
—Sodium salt F027
—Triethanolamine salt F027
—Triethylanine salt F027
—Alkyl (C3H7 - C7H9) ester F027
—Amyl ester F027
—Butoxyethoxypropyl ester F027
—2-Butoxyethyl ester F027
—Butoxypropyl ester F027
—Butyl ester F027
—Dipropylene glycol isobutyl F027
ether ester
—2-Ethylhexyl ester F027
—Isobutyl ester F027
53404-13-0
69622-82-8
83562-66-7
2818-16-8
53466-84-5
37913-89-6
17369-89-0
53404-74-3
53404-75-4
53535-30-1
3570-61-4
25167-83-3
53535-27-6
25567-55-9
95-95-4
88-06-2
53404-83-4
136-32-3
3784-03-0
93-79-8
53404-84-5
53404-85-6
53535-37-8
53404-86-7
6369-97-7
53404-88-9
53404-89-0
53404-87-8
13560-99-1
3813-14-7
2008-46-0
120-39-8
1928-58-1
2545-59-7
1928-48-9
93-79-8
53535-31-2
1928-47-8
4938-72-1
113
-------
PEST/DIS-5
—Isopropyl ester F027 93-78-7
—Propylene glycol isobutyl F027 53466-86-7
ether ester
—Tripropylene glycol isobutyl F027 53535-32-3
ether ester
4-{2,4,5-Trichlorophenoxy)butyric F027 93-80-1
acid [2,4,5-TB]
2-(2,4,5-Trichlorophenoxy)ethyl F027 69633-04-1
hydrogen sulfate [2,4,5-TES]
l,4I,5'-Trichloro-2I-(2,4,5- F027 69462-14-2
trichlorophenoxy)
methanesulfonanilide [Edolan U]
114
-------
PEST/DIS-6
U002
U009
U011
U019
U028
U136
U211
U034
U036
U037
U039
U044
U048
U051
U052
U056
U057
U142
67-64-1
107-13-1
61-82-5
71-43-2
117-81-7
75-60-5
56-23-5
302-17-0
57-74-9
108-90-7
59-50-7
67-66-3
95-57-8
8021-39-4
1319-77-3
110-82-7
108-94-1
143-50-0
PESTICIDES THAT ARE TOXIC HAZARDOUS WASTES
PESTICIDES ON THE "F" LIST (with RCBA », and CAS *
[40 CFR 261.33(f)]
Acetone
Acrylonitrile*
Anitrole
Benzene*
Bis(2-ethylhexyl) phthalate
Cacodylic acid
Carbon tetrachloride*
Chloral (hydrate)
(chloroacetaldehyde)
Chlordane, technical*
Chlorobenzene*
4-Chloro-m-cresol
Chloroform*
o-Chlorophenol
Creosote
Cresylic acid (cresols)*
Cyclohexane
Cyclohexanone
Decachlorcoctahydro-1,3,4-metheno-
2H-cyclobuta[c,d]-pentalen-2-one
(Kepone, chlordecone)
1,2-Dibrano-3-chloropropane (DBCP)
Dibutyl phthalate
S-2,3-(Dichloroallyl diisopropyl-
thiocarbamate) (diallate,Avadex)
o-Dichlorobenzene*
p-Dichlorobenzene*
Dichlorodifluorcroe thane
(Freon 12®)
3,5-Dichloro-N-(1,l-dimethyl-2-
propynyl) benzamide
(pronamide, Kerb®)
Dichloro diphenyl dichloroethane
(ODD)
Dichloro diphenyl trichloroethane
(DDT)
Dichloroethyl ether
2,4-Dichlorophenoxyacetic,
salts and esters (2,4-D)*
1,2-Dichloropropane
1,3-Dichloropropene (Telone)
Dimethyl phthalate
Epichlorohydrin
(l-chloro-2,3-epoxypropane)
Ethyl acetate
Ethyl 4,4'-dichlorobenzilate
(chlorobenzilate)
U066
U069
U062
U070
U072
U075
96-12-8
84-74-2
2303-16-4
95-50-1
106-46-7
75-71-8
U192
U060
U061
U025
U240
U083
U084
U102
U041
U112
U038
23950-58-5
72-54-8
50-29-3
1191-17-9
94-75-7
8003-19-8
542-75-6
131-11-3
106-89-8
141-78-6
510-15-6
*Proposed for deletion by TCLP proposal
115
-------
PEST/DIS-7
Ethylene dibromide (EDB)
Ethylene dichloride*
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene*
Hexachlorocyclopentadiene
Hexachloroethane*
Hydrofluoric acid
Isobutyl alcohol*
Lead acetate
Lindane*
Maleic hydrazide
Mercury
Methoxychlor*
Methyl alcohol (raethanol)
Methyl bromide
Methyl chloride
2,2'-Methylenebis
(3,4,6-trichlorophenol)
(hexachlorophene)
[acute waste per 261.31]
Methylene chloride*
Methyl ethyl ketone*
4-Methyl-2-pentanone
(methyl isobutyl ketone)
Naphthalene
Nitrobenzene*
p-Nitrophenol
Pentachloroe thane
Pentachloronitrobenzene (PCNB)
Pentachlorophenol*
[acute waste per 261.31]
Phenol*
Pyridine*
Resorcinol
Safrole
Seleniun disulfide
Silvex [acute waste per 261.31]
1,1/2,2-Tetrachloroethane*
Tetrachloroethylene*
2,3,4,6-Tetrachlorophenol*
[acute waste per 261.31]
Thiram
Toluene*
1,1,1-Trichloroethane*
(methyl chloroform)
Trichloroethylene*
Tri chlor ononofluor one thane
(Freon 11®)
2,4,5-Trichlorophenol*
[acute waste per 261.31]
2,4,6-Trichlorophenol*
[acute waste per 261.31]
U067
U077
U115
U122
U125
U127
U130
U131
U134
U140
U144
U129
U148
U151
U247
U154
U029
U045
U132
U230
106-93-4
107-06-2
75-21-8
50-00-0
98-01-1
118-74-1
77-47-4
67-72-1
7664-39-3
78-83-1
301-04-2
58-89-9
123-33-1
7439-97-6
72-43-5
67-56-1
74-83-9
74-87-3
70-30-4
U080
U159
U161
U165
U169
U170
U184
U185
U242
U188
U196
U201
U203
U205
U233
U209
U210
0212
U244
U220
U226
75-09-2
78-93-3
108-10-1
91-20-3
98-95-3
100-02-7
76-01-7
82-68-8
87-86-5
108-95-2
110-86-1
108-46-3
94-59-7
7488-56-4
93-72-1
79-34-5
127-18-4
137-26-8
108-88-3
71-55-6
U228 79-01-6
U121 75-69-4
95-95-4
U231 88-06-2
116
-------
PEST/DIS-8
2,4,5-Trichlorophenoxyacetic acid U232 93-76-5
(2,4,5-T)*
[acute waste per 261.31]
Warfarin «0.3%) U248 81-81-2
Xylene U239 1330-20-7
Zinc phosphide «10%) U249 1314-84-7
83 ACTIVES
117
-------
III. U3E INDEX APPENDIX
118
-------
EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOPROPYLAMINE SALT*
TYPE PESTICIDE; Herbicide
FOLIATIONS;
FI(3 Ib/gal, 4 Ib/gal, 62%)
EC (1.04 Ib/gal)
SC/L (0.42 Ib/gal, 3 Ib/gal, 4 Ib/gal, 5%, 6.6%)
RTU (0.5%, 0.96%, 1%)
PrL (0.75%)
GENERAL WARNINGS AND LIMITATIONS: Glyphosate is a broad spectrum post-
emergence systemic herbicide that can be used for the control of most
annual weeds, a large number of herbaceous and woody perennials, and
grasses. Because of the non-selective nature of this herbicide, it may
be applied either as a broadcast spray before planting or before emergence
of the crop, or as a directed application in established crops, or to
control weeds that are taller than the crop using recirculating or wiper
applicators, or as a broadcast spray to achieve total vegetation kill for
turf renovation or site preparation. It may also be used for weed control
in non-crop areas and for spot treatment in crops. Apply with a nonionic
surfactant. Do not allow spray, drift, or mist to come in contact with
green foliage, green stems, or fruit of crops, desirable plants, or trees.
Spray contact with any part other than mature bark on the main trunk of
trees can result in serious damage to the plant. For best results, weeds
should be actively growing and not under stress of drought or disease at
the time of application. Control of perennials increases with plant ma-
turity at the time of application. If weeds or brush have been mowed, or
trees have been cut, allow regrowth to reach the recommended stage prior
to application. Rainfall or irrigation occuring within 6 hours may reduce
effectiveness; heavy" rainfall or irrigation within 2 hours after applica-
tion may require retreatment. Use the higher dosages and gallonages for
control of dense vegetation unless otherwise specified. Do not disturb
treated vegetation for a few days, and delay tillage for up to 7 days
after application.
Thoroughly spray weed foliage, but not to the point of run-off. Repeat
treatments may be necessary to control late germinating weeds or weeds
regenerating from underground rhizomes.
Glyphosate does not provide residual control; plants that emerge after
treatment will not be controlled. Dosages have been calculated using the
acid equivalent of glyphosate. Tolerances have been given for combined
residues of glyphosate (N-(phosphonomethyl)glycine) and its metabolite
aiainomethylphosphonic acid.
*Roundup
N-(phosphonomethyl)glycine, isopropylamine salt
Issued: 11-01-83 1-103601-1
119
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EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOPROPYLAMINE SALT
METHODS OF APPLICATION (continued)
Wiper Applicators (Roller or Wick) - For roller applications, mix 3 Ibs
a.e. in 9 or 19 gallons of water. Maintain roller speed at 40 to 60 RPM.
For wick applicators mix 3 Ibs a.e. in 2 gallons of water. In severe
infestations, reduce ground speed to ensure proper weed contact. Best
results may be obtained if 2 applications are made in opposite directions.
Hand-Held Wipers - These are small-scale wiper applicators used for spot
treatments.
TIME REQUIRED FOR CONTROL; Visible effects occur in 2 to A days on annual
weeds and in 7 to 10 days on perennials.
PHYTOTOXICITY TO TARGET WEEDS; A gradual wilting and yellowing, leading
to browning and necrosis.
PKYTOTOXICITY TO CROPS; Same as for the weeds.
MODE OF ACTION; The proposed mechanism of action is in the inhibition of
the aromatic amino acid biosynthesis pathway leading to reduced protein
synthesis and inhibited growth.
BROADLEAF WEEDS CONTROLLED;
BIBE Alfalfa
AAAB Annual broadleaf w*>eds
AAAE Annual weeds
AKAA As ter
\AAG Biennial weeds
AFBJ Bigroot morningglory (9)(24)
&CAA Bindweed
BIBB Black medic
ADDH Blackseed plantain
AKBA Blue mustard
3AAA Brassbuttons
ABBD Broadleaf plantain
\AAC Broadleaf weeds
ABBC Buckhorn plantain
WBG Bull thistle
3IAA Burclover
\GAA Buttercup
\WBB Canada thistle (3)(5) (14)
:AAA Catsear
\AAC Chickweed
VVBA Chicory
^AAB Clover
VSBB Coast fiddleneck
DQAA Cocklebur (7)
\OBB Common chickweed
IXBK Common groundsel
Issued: 11-01-83 1-103601-3
£ I
-------
EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOPROPYLAM1NE SALT
BROADLEAF WEEDS CONTROLLED (continued)
'ZAAAHH Little bittercress
'AZAOBA Little starwort
'BKBDBB London rocket
'DAAHAA Mallow
'BFAHBB Mayweed
'AMAAAB Milkweed
>EFADBA Moneywort
'BGAAAB Morning glory
'AZADBC Mouseear chickweed
'BFAQBC Musk thistle
'BKAAAC Mustard
•EWAIAA Nightshade
•AAAACV Nimblewill
•EMAHAA Oldenlandia
'EUAIBA Oldfield toadflax
'EAAGBO Pennsylvania smartweed
FFARAA Pennywort
•BKAWAA Pepperweed
'AAAAAD Perennial broadleaf weeds
'AAAAAF Perennial weeds
AAAABI Pigweed
DXABAA Plantain
BFCEBF Prickly lettuce
EFAEAA Primrose
EAAGBD Prostrate knotweed
AFACBC Prostrate pigweed
BVAGBQ Prostrate spurge
FMAFBB Puncturevine
BF3PBF Purple cudweed '
AAAABP Purslane
BFAEAA Ragweed
CQBYBH Red clover
COAFBC Red deadnettle
ZAAHBB Red sorrel
AFACBI Redroot pigweed
BDAKBA Russian thistle
BKAHBA Shepherdspurse
EWAIBD Silverleaf nightshade
BKAGBB Siaallseed falseflax
EAAGAD Smartweed
BFCABA Smooth catsear
tfACBE Smooth pigweed
EAAHAB Sour dock
BFDCAA Sowthistle
BFAOBA Spanishneedles
BVAGBK Spotted spurge
BVAGAA Spurge
ZAAAGJ Spurweed
FGAEBA Stinging nettle
BF3UAA Sunflower
EAAGBG Swamp smartweed
Issued: 11-01-83
(3)(5)(16)
1-103601-5
t23
-------
EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOFROPYLAMINE SALT
BROADLEAF WEEDS CONTROLLED (continued)
(18) Apply 3 Ib a.e./A when most weeds have reached the late bud to
flower stage. Apply in late summer or fall for best results.
Allow 7 or more days after application before tillage.
(20) Apply 3 to 3.75 Ib a.e./lOO gal using hand-held equipment only.
Apply when weeds are at or beyond the bloom stage. Use higher
dosage for weeds that have reached the woody stage. Allow 7 or
more days after application before tillage.
(21) Apply 2.25 Ib a.e./A when most weeds have reached the late bud to
flower stage. Allow 7 or more days after application before til-
lage.
(24) Apply 6 Ib a.e./lOO gal using hand-held equipment to weeds that
are at or beyond the bloom stage. Repeat applications will be
required. Allow 7 or more days after application before tillage.
(30) Apply 3 Ib a.e./A as a broadcast spray, or 6 Ib a.e./lOO gal using
hand-held equipment for control. Repeat applications will be
necessary to maintain control.
GRASSES AND OTHER IIONOCOTS CONTROLLED;
PCA3MBE Alta fescue
PCACKBA Annual bluegrass
PCAAAAB Annual grasses
PCACFBM Bahiagrass
PCABSAA Barley (volunteer)
PCABHBB Barnyardgrass
PCAADAA Bentgrass
PCAAZBA Bermudagrass (3)(5)(11)
PCAAAAN Biennial grasses
PCACKAA Bluegrass
PCAATAA Brome
PCACFBN Brownseed paspalum
PCACXBB Bulbous bluegrass
PCADHBA Centipedegrass
PCACTBA Common rye (2)(4)
PCADPBA Corn (volunteer) (2)(A)(8)
PCABFAA Crabgrass
PCAADBC Creeping bentgrass
PCACFBC Dallisgrass
PCAATBM Downy brome
PCABMAA Fescue
PCAAWBB Field sandbur
PCACUAA Foxtail
PCADEBA Giant cutgrass
PCABIBA Goosegrass
PCABUBF Green foxtail
Issued: 11-01-83
1-103601-7
125
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EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOPROPYLAMINE SALT
GRASSES AND OTHER MONOCOTS CONTROLLED (continued)
(9) Apply 1.5 Ib a.e./A for control.
(10) Partial control only.
(11) Apply 2.25 to 3.75 Ib a.e./A. Use the lower dosage for partial
control and the higher dosage for control. Apply when seedheads
are present. Retreatment may be necessary for control. Allow 7
or more days after application before tillage.
(13) Apply 1.5 to 2.25 Ib a.e./A when most grasses have reached the
boot to head stage. Allow 7 or more days after application before
tillage.
(17) Apply 2.25 Ib a.e./A, or 3 Ib a.e./lOO gal using hand-held equip-
ment when most weeds have reached the 7-leaf stage. Allow 7 or
more days after application before tillage.
(19) In annual cropping systems apply 0.75 to 1.5 Ib a.e./A, using
0.75 Ib a.e. plus surfactant in 5 to 10 gallons of water per acre;
or 1.5 Ib a.e in 10 to 40 gallons of water per acre. In noncrop
areas or in areas where annual tillage is not performed, apply
1.5 to 2.25 Ib a.e. in 10 to 40 gallons of water per acre. For
best results, apply when most weeds are at least 18 inches in
height and have reached the boot to head stage of growth. Allow
7 or more days after application before tillage. Do not tank mix
with residual herbicides when applying 0.75 Ib a.e./A rate.
(22) Apply 2.25 Ib a.e./A as a broadcast spray, or 3 Ib a.e./lOO gal
using hand-held equipment to control existing weeds and Immature
nutlets attached to treated weeds. Apply when weeds are in flower
or when new nutlets can be found at rhizome tips. Nutlets which
have not germinated will not be controlled. Repeat. Tillage will
stimulata nutlet germination.
(23) In annual cropping systems apply 0.75 to 1.5 Ib a.e./A, using
0.75 Ib a.e. plus a surfactant in 5 to 10 gallons of water per
acre; or 1.5 Ib a.e. in 10 to 40 gallons of water per acre. In /
pastures, areas coming out of sod, areas which are not tilled, or
areas where annual crops are not grown, apply 1.5 to 2.25 Ib a.e.
in 10 to 40 gallons of water per acre. Make applications when
weeds are 8 to 12 inches in height (3- to 4-leaf stage). Do not
till between harvest and fall applications or in the fall or
spring prior to spring applications. Allow 3 or more days after
application before tillage. Do not tank mix with residual herbi-
cides when applying 0.75 Ib a.e./A.
(25) Apply 3 to 3.75 Ib a.e./A to provide partial control when most
weeds are at or beyond the seedhead stage. To maintain control,
repeat applications will be required. Make fall applications be-
fore a frost. Allow 7 or more days after application before til-
lage.
Issued: 11-01-83 1-103601-9
\^l.
-------
EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOPROPYLAMINE SALT
WOODY PLANTS CONTROLLED (continued)
'AQACBA Trumpetcreeper
'CZABBA Tuliptree
'ACABBB Vine maple
'FKADBA Virginia creeper
BWAFBB White oak
'EOACAA Willow
AHABBB Winged sumac
(10) Partial control only.
(28)
(10)
(10)
(10)
(35)
(10)
(27) Apply 2.25 to 3 Ib a.e./A as a broadcast spray, or 3 to 4.5 Ib
a.e./lOO gal using hand-held equipment for weed control.
(28) Apply 1.5 to 2.25 Ib a.e./A as a broadcast spray, or 3 to 4.5 Ib
a.e./lOO gal using hand-held equipment for weed control.
(29) Apply 1.5 Ib a.e./A as a broadcast spray, or 3 Ib a.e./lOO gal
using hand-held equipment for weed control.
(32) Apply 3 to 3.75 Ib a.e./A as a broadcast spray, or 6 Ib a.e./lOO
gal using hand-held equipment. Repeat applications may be neces-
sary to maintain control. Make fall applications before leaves
lose green color.
(33) Apply 3 to 4.5 Ib a.e./lOO gal using hand-held equipment for weed
control when at least 50 percent of the new leaves are fully de-
veloped.
(34) Apply 1.5 to 3 Ib a.e./A as a broadcast spray for partial control
when weeds are at or beyond full flowering.
(35) Apply 2.25 Ib a.e./A as a broadcast spray, or 3 Ib a.e./lOO gal
using hand-held equipment for weed control.
(40) Apply 1 ml/2 to 3 inch DBH by frill or injection treatment for
control.
(41) Apply 1 ml/2 to 3 inch DBH by frill or injection treatment for
suppression.
AQUATIC WEEDS CONTROLLED;
AFABBA Alligatorweed
FDABAA Cattail
IGABAA Chara
CACJAA Phragmites
DLAEBA Spatterdock
(36)
(37)
(38)
(39)
Issued: 11-01-83
1-103601-11
1 29
-------
EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOPROPYLAMINE SALT
Toleranr.p, Use. Limitations
/23001AA
/24001AA
/24003AA
/24006AA
/24007AA
/03001AA
/03005AA
/03007AA
/C3003AA
/03011AA
/03009AA
Site. Dosage
and Formulation
(Ib a.e./A)
TERRESTRIAL FOOD CROP
(Agricultural Crops)
General Warnings and Limitations; Applications may be made using any
type of equipment outlined under Methods of Application, except as indi-'
cated in use paragraphs.
Alfalfa
Barley
Oats
Sorghum (Milo)
Wheat
0.75-1.5
(3 Ib/gal SC/L)
0.75-3.75
(3 Ib/gal SC/L)
0.2 ppm (fresh alfalfa and alfalfa hay)
0.1 ppm (grain crops)
Do not graze or feed treated foliage to livestock
within 8 weeks after application. The combined
total of all treatments must not exceed 6 Ib a.e./A
per year. Do not plant subsequent crops other than
those registered for glyphosate for 1 year follow-
ing application.
Preplant. Broadcast. Annual weed control. Use
the higher dosage when weeds are more than 6 inches
tall.
Preplant. Broadcast. Perennial weed control.
3-6 Ib a.e./lOO gal Postecergence. Spot treatment. Apply prior to
(3 Ib/gal SC/X) heading of scall grains and milo. Do not treat
more than 10 percent of the total field area to be
harvested.
Almond
Filbert
Macadamia Nut
Pecan
Pistachio
Walnut
0.2 ppm (nuts)
1.0 ppm (almond hulls)
Twenty-one day preharvest interval. Do not graze
or feed treated foliage to livestock within 8 weeks
after application. (
Refer to Apple cluster for general information and
use and dose instructions.
Issued: 11-01-83
1-103601-13
131
-------
Site, Dosage
and Formulation
(Ib a.e./A)
EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOPROPYLAKINE SALT
Tolerance. Use, Limitations
/05001AA
/05003AA
/05005AA
/05006AA
Apricot
Nectarine
0.2 ppn (stone fruits)
Fourteen day preharvest interval. Do not graze or
feed treated forage to livestock within 8 weeks
after application.
General Information; Any appropriate method of
application may be used in AZ, CA, CO, ID, KD, OK,
OR, TX, UT and WA. In all other states use wiper
equipment only.
\
Refer to Apple cluster for general information ar,a
use and dose instructions*
/14009AA
/28001AA
/L3001AA
/14001AA
/L3007AA
/1A003AA
/13008AA
/13003AA
/1A008AA
/13011AA
/15011AA
/13011AA
/13021AA
/L5015AA
/14011AA
/28016AA
/14013AA
/14014AA
/13024AA
/25002AA
/14018AA
Artichoke (Jerusalem)
Beans
Beet Greens
Beets (red)
0.2 ppm (leafy vegetables, root crop vegetables,
seed and pod vegetables, seed and pod
vegetable forage and hay)
Do not graze or feed treated foliage to livestock
within 8 weeks after application. The combined
total of all treatments must not exceed 6 Ib a.e./A
per year. Do not plant subsequent crops other
than those registered for glyphosate for 1 year
following application.
Cabbage
Carrot
Cauliflower
Chicory"
Horseradish
Kale
lentils
Lettuce
Mustard Greens.
Okra
Onion
Peas
Potato (Irish)
Radish
Spinach
Sugar Beets
Sweet Potato
0.75-1.5 Preplant. Broadcast. Annual weed control. Use
or the higher dosage where weeds are more than 6
3 Ib a.e./lOO gal inches tall.
(3 Ib/gal SC/L)
0.75-3.75
or
Preplant. Broadcast.
control.
Perennial weed and brush
3-6 Ib a.e./lOO gal
(3 Ib/gal SC/L)
Issued: 11-01-83
1-103601-15
133
-------
:06002AA
33017BA
Site. Dosage
and Formulation
(it) a.e./A;
Banana
Bermudagrass (seed
crop)
0.28
(3 Ib/gal SC/L)
'07002AA
EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOPROPYLAKINE SALT
Tolerance, Use, Limitations
0.2 ppm
Do not graze or feed treated foliage to livestock
within 8 weeks after application.
General Information; Delay application for 3
months after transplanting to allow plants to be-
come established.
Refer to Apple cluster for general information and
use and dose instructions.
See Alfalfa cluster.
N.F. (seed)
0.2 ppm (forage grasses)
Dormant application. Broadcast. For the control
of annual bluegrass. Apply to actively growing
annual bluegrass prior to initiation of bermuda-
grass greenup in the spring. Apply in 5 to 20
gallons of water per acre with a nonionic surfac-
tant.
See Artichoke (Jerusalem) cluster.
See Artichoke (Jerusalem) cluster.
See Artichoke (Jerusalem) cluster.
See Apple cluster.
See Artichoke (Jerusalem) cluster.
1 ppm (coffee beans)
Fourteen day preharvest interval. Do not graze or
feed treated foliage to livestock within 8 weeks
after application.
General Information; Delay application for 3
months after transplanting to allow plants to be-
come established.
Refer to Apple cluster for general information and
use and dose instructions.
Issued: 11-01-83
1-103601-17
135
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EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOPROPYLAMINE SALT
Site, Dosage Tolerance, Use, Limitations
and Formulation
(Ib a.e./A)
Corn (continued)
1.5-3 At planting or preemergence in minimum tillage
(3 Ib/gal SC/L) systems. Perennial weed control. At normal ap-
plication dates in minimum tillage systems, weeds
may not be at proper growth stage for control.
When applied under these conditions, application
will provide top kill and will reduce competition
from many emerged perennial grasses and broadleaf
weeds. To spray at the desired growth stage, it
nay be necessary to apply glyphosate alone in the
late summer or fall and then follow with a label
approved seedling weed control program at planting.
Tank mix with alachlor; alachlor plus atrazine;
alachlor plus bladex; alachlor plus simazine; or
atrazine plus simazine.
3-6 Ib a.e./lOO gal Posteniergence. Spot Treatment. Apply prior to
(3 Ib/gal SC/L) silking of corn. Do not treat more than 10 percent
of the total field area to be harvested.
J07AA
Cotton
0.75-1.5
or
3 Ib a.e./lOO gal
(3 Ib/gal SC/L)
0.75-3.75
or
3-6 Ib a.e./lOO gal
(3 Ib/gal SC/L)
15 ppm (cottonseed, forage, hay)
Seven day preharvest interval. Do not graze
treated fields or feed treated forage to livestock.
The combined total of all applications must not
exceed 6 Ib a.e./A per year. Do not plant subse-
quent crops other than those registered for gly-
phosate for 1 year following application.
General Information; Do not apply to crops grown
for seed.
Preplant. Broadcast. Annual weed control. Use
the higher dosage for weeds over 6 inches tall.
Preplant,
control.
Broadcast. Perennial weed and brush
3-6 Ib a.e./lOO gal Postemergence. Spot treatment. Apply prior to
(3 Ib/gal SC/L) boll opening. Do not treat more than 10 percent
of the total field area to be harvested.
Issued: 11-01-83
1-103601-19
137
-------
J14AA
Site, Dosage
and Formulation
(Ib a.e./A)
Grapes
D66BA
Grasses Grown for
Seed
EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOPROPYLAMINE SALT
Tolerance, Use, Limitations
0.2 ppm
Fourteen day preharvest interval. The combined
total of all applications must not exceed 7.95 Ib
a.e./A per year.
General Information; Avoid contact of spray with
green foliage, green bark, suckers, or vines and
renewals less than 3 years of age. In the north-
east and Great Lakes regions, apply prior to the
end of bloom stage of grapes.
Refer to Apple cluster for general information and
use and dose instructions.
N.F. (seed)
0.2 ppn (forage grasses)
Do not feed or graze treated areas within 8 weeks
after application.
General Information; Do not disturb soil before
treatment. Tillage should be delayed for 7 days
after application. Delay planting to determine if
there is any regrowth from underground parts.
Where repeat applications are necessary, allow
sufficient regrowth of vegetation. Summer or fall
applications provide best control of warm season
grasses.
Site preparation. Broadcast. Annual weed control.
Use the hi*gher dosage when weeds are over 6 inches
tall. !
[500 6AA
WOAA
0.75-1.5
or
3 Ib a.e./lOO gal
(3 Ib/gal SC/L)
1.5-3.75 Site preparation. Perennial weed and woody brush
or control. Repeat treatment may be necessary to
3-6 Ib a.e./lOO gal control plants generating from underground
(3 Ib/gal SC/L) rhizomes or late germinating weeds.
0.2 ppm
One day preharvest interval. Do not graze or feed
treated foliage to livestock within 8 weeks after
application.
Refer to Apple cluster for general information and
use and dose instructions.
Horseradish
See Artichoke (Jerusalem) cluster.
Issued: 11-01-83
1-103601-21
139
-------
;004AA
28015AA
EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOPROPYLAMINE SALT
Site, Dosage Tolerance, Use, Limitations
and Formulation
(Ib a.e./A)
Peach 0.2 ppm
Fourteen day preharvest interval. Do not graze on
feed treated foliage to livestock within 8 weeks
after application.
Use limited to AL, AR, FL, NC, SC and TN. Directed1
spray. Apply with a shielded boom sprayer or
shielded wiper applicator. When using a shielded
wiper applicator, dilute 1 gallon of product in 4
gallons of water. To avoid injury, apply no later
than 90 days after first bloom. Remove suckers
and low hanging limbs at least 10 days prior to
application. Avoid making applications near trees
with recent pruning wounds. Apply near trees that
are 2 or more years old.
0.75-1.5 Use limited to AZ, CA, CO, ID, ND, OK, OR, TX, UT
or and WA. Broadcast. Annual weed control. Use the
3 Ib a.e./lOO gal higher dosage when weeds are over 6 inches tall.
(3 Ib/gal SC/L)
0.75-3.75 Use limited to AZ, CA, CO, ID, ND, OK, OR, TX, UT,
or • and WA. Broadcast. Perennial weed and brush con-
3-6 Ib a.e./lOO gal trol.
(3 Ib/gal SC/L)
0.75-3.75
or
3 Ib a.e.M gal
(3 Ib/gal SC/L)
3 Ib a.e./A gal
(3 Ib/gal SC/L)
Peas
Peanuts
0.75-1.5
or
3 Ib a.e./lOO gal
(3 Ib/gal SC/L)
0.75-3.75 Preplant,
or control.
3-6 Ib a.e./lOO gal
(3 Ib/gal SC/L)
Use limited to states other than AZ, CA, CO, ID,
KD, OK, OR, TX, UT and WA. Wiper applications.
See Artichoke (Jerusalem) cluster.
t
0.1 ppm (peanuts)
0.5 ppm (forage, hay, hulls)
The combined total of all treatments must not ex-
ceed 6 Ib a.e./A per year. Do not plant subsequent
crops other than those registered for glyphosate
for 1 year following application.
Preplant. Broadcast. Annual weed control. Use
the higher dosage when weeds are more than 6 inches
tall.
Broadcast. Perennial weed and brush
Issued: 11-01-83
1-103601-23
141
-------
EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOPROPYLAMINE SALT
Site, Dosage Tolerance, Use, Limitations
and Formulation
(Ib a.e./A)'
Soybeans (continued)
l»5-3 At planting or preemergence in minimum tillage
(3 Ib/gal SC/L) systems. Perennial weed control. At normal ap-
plication dates in minimum tillage systems, weeds
may not be at proper growth stage for control.
When applied under these conditions, application
will provide top kill and will reduce competition
from many emerged perennial grass and broadleaf
weeds. To spray at the desired growth stage of
weeds, it may be necessary to apply glyphosate
alone in the late summer or fall and then follow
with a la'bel approved seedling weed control program
at planting.
Tank mix with alachlor; alachlor plus atrazine;
alachlor plus bladex; alachlor plus simazine; or
atrazine plus simazine.
3-6 Ib a.e./lOO gal Postemergence. Spot treatment. Apply prior to
(3 Ib/gal SC/L) initial pod set. Do not treat more than 10 percent
of the total field area to be harvested.
:5003AA
Sjpinach
Sugar Beets
Sugarcane
0.75-1.5
or
3 Ib a.e./lOO gal
(3 Ib/gal SC/L)
0.75-3.75
or
3-6 Ib a.e./lOO gal
(3 Ib/gal SC/L)
See Artichoke (Jerusalem) cluster.
See Artichoke (Jerusalem) cluster.
2.0 ppm (sugarcane)
30 ppm (sugarcane molasses)
Do not graze or feed treated foliage to livestock
within 8 weeks after application. The combined
total of all treatmpnts must not exceed 7.95 Ib
a.e./A per year.
General Information; Do not apply to vegetation
in or around ditches, canals or ponds containing
water to be used for irrigation.
Preplant. Broadcast. Annual weed control. Use
the higher dosage when weeds are over 6 inches
tall.
Preplant. Broadcast. Perennial weed control.
Issued: 11-01-83
1-103601-25
143
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EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOPROPYLAKINE SALT
Tolerance, Use, Limitations
Site. Dosage
and Formulation
(Ib a.e./A)"
(Non-Crop and General Outdoor Treatments)
>0020A
Fallowland
0.19
(3 Ib/gal SC/L)
0.28
(3 Ib/gal SC/L)
0.38
(3 Ib/gal SC/L)
0.28
(3 Ib/gal SC/L)
0.38
(3 Ib/gal SC/L)
N.F.
Do not plant field crops other than those regis-
tered for glyphosate for 1 year following applica-
tion. The combined total of all treatments must
not exceed 6 Ib. a.e./A per year.
General Information; These dosages may also be
use'd in reduced tillage systems prior to emergence
of the crop. Do not apply dicamba, dimethylaminp
salt or 2,4-D, dimethylamine salt tank mixtures by
air" in CA. Some crop injury may occur if dicamba,
dimethylamine salt is applied within 45 days of
planting. Refer to specific product labels for
crop rotation restrictions of tank mix chemicals.
Preplant. Broadcast. For the control of foxtail.
Apply by ground in 3 to 10 gallons or by air in 3
to 5 gallons of water per acre with a nonionic
surfactant.
Preplant. Broadcast. For the control of downy
brone, volunteer barley, barnyardgrass, jagged
chickveed, mustard (blue, tansy, tumble, wild),
volunteer rye and volunteer wheat. Apply by ground
in 3 to 10 gallons or by air in 3 to 5 gallons of
water per acre with a nonionic surfactant.
Preplant. Broadcast. For the control of annual
ryegrass, bulbous bluegrass, laabsquarters, field /
pennycress, smallseed falseflax and wild oats.
Apply by ground in 3 to 10 gallons or by air in 3
to 5 gallons of water per acre with a nonionic
surfactant*
Preplant. Broadcast. For the control of field
bindweed, kochia, lambsquarters, prickly lettuce,
redroot pigweed and Russian thistle.
Tank mix with dicamba", dimethylamine salt.
Preplant. Broadcast. For the control of kochia,
prickly lettuce and Russian thistle.
Tank mix with 2,4-D, dimethylamine salt.
Issued: 11-01-63
1-103601-27
145
-------
(017AA
IOOOOA
I008AA
Site, Dosage
and Formulation
(lb a.e./A)
Bermudagrass (Common
and Coastal)
0.75-1.13
(3 Ib/gal SC/L)
0.75
(3 Ib/gal SC/L)
Ornamentals
EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOPROPYLAMINE SALT
Tolerance. Use, Limitations
0.75-1.5
or
3 lb a.e./lOO gal
(3 Ib/gal SC/L)
1.5-3.75
or
3-6 lb a.e./lOO gal
(3 Ib/gal SC/L)
Ornamental Turf
Roadside release of bermudagrass. For partial
control of rhizome johnsongrass. Some injury may
result from application, but regrowth will occur
under moist conditions. Repeat applications during
the same season are not recommended.
Roadside release of bermudagrass. For control of
Johnsongrass. Some injury may occur, but regrowth
will occur under moist conditions.
Tank mix with sulfometuron methyl.
General Information: Any ornamental species may
be planted following preplant applications. When
repeat applications are necessary, do not exceed
7.95 pounds a.e./A per year.
Site preparation. Annual weed control. Use the
higher dosage when weeds are over 6 inches tall.
Repeat treatments may be necessary to control late
germinating weeds.
Site preparation.
control.
0.75-1.5
or
3 lb a.e./lOO gal
(3 Ib/gal SC/L)
Perennial weed and woody brush
General Information; Do not disturb soil before
treatment. Renovation techniques should be delayed
for 7 days after application. Turfgrass may be
planted after control is evident. Where existing
vegetation is growing under mowed conditions, apply
after omitting at least 1 mowing to allow suffi-
cient vegetative growth. Where repeat applications
are necessary, allov sufficient regrowth of vege-
tation. Summer or fall applications provide best
control in warm season grasses.
Turf renovation or site preparation. Broadcast.
Annual weed control. Use the higher dosage when
weeds are over 6 inches tall.
Issued: 11-01-83
1-103601-29
147
-------
EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOPROPYLAMINE SALT
Site, Dosage Tolerance, Use, Limitations
and Formulation
(lb a.e./A)
Airports cluster (continued)
0.75-1.5 Annual weed control in industrial, recreational
or and public areas. Use the higher dosage when weeds
3 lb a.e./lOO gal are over 6 inches tall.
(3 Ib/gal SC/L) May be tank mixed with bromacil and diuron; sima-
zine; or oryzalin.
1.5-3.75 Perennial weed and woody brush control in indus-
or trial, recreational and public areas.
3-6 lb a.e./lOO gal May be tank mixed with bronacil and diuron; sima-
(3 Ib/gal SC/L) zine; or oryzalin.
1.5-2.25 Johnsongrass control. Apply anytime from early
(3 Ib/gal SC/L) posteinergence through the boot to head stage.
Tank mix with sulfoiaeturon methyl.
Also refer to AQUATIC NON-FOOD, Agricultural
Drainage Systems cluster for additional information
pertinent to Ditch Banks, Dry'Ditches and Canals.
GREENHOUSE NON-FOOD CROP
(Ornamental Plants and Forest Trees)
10060A Greenhouse
3-6 lb a.e./lOO gal Spot treatment. Thoroughly spray weed foliage.
(3 Ib/gal SC/L) Desirable vegetation must not be present during
application and air circulation fans must be turned!
off.
DOMESTIC OUTDOOR
(Household)
GENERAL WARNINGS AND LIMITATIONS; Make spot treatments to kill undesir-
able weeds and grasses around trees, shrubs, in ornamental plantings,
landscaped sites or mulched areas, along sidewalks, driveways, gravelled
pathways, fences, patios, around buildings, lawns, gardens, and parking
areas. Overall spray applications may be made where total vegetation
kill is desired for lawn renovation or landscaping. Wiper, wick or
sponge type applicators may be used with undiluted concentrates where
specified. If foliage of desirable plants is accidentally sprayed, im-
mediately wash off with water. Do not cut treated vegetation for 7 days
after application. Hard-to-kill weeds and grasses may require retreat-
ment after 14 to 21 days.
Issued: 11-01-83 1-103601-31
-------
EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOPROPYLAMINE SALT
Site, Dosage Tolerance. Use, Limitations
and Formulation
(Ib a.e./A)
Flower Beds cluster (continued)
(0.96% RTU)
fllOOA Ornamental Lawns
General Information; Treated lawn can be reseeded
or sodded after 7 days.
8 fl.oz product/^al Spot treatment.
(0.42 Ib/gal SC/L)
(5% SC/L)
6 fl.oz product/gal
(6.6% SC/L)
(0.5% RTU)
(0.96% RTU)
(0.75% PrL)
0.53 Ib a.e./ Broadcast application for lawn renovation.
5,000 sq.ft
or
1.25 gal product/
5,000 sq.ft
(O.A2 Ib/gal SC/L)
(5% SC/L)
0.94 gal product/
5,000 sq.ft
(6.6% SC/L)
(0.5% RTU)
151
Issued: 11-01-83 1-103601-33
-------
Site, Dosage
and Formulation
Ub a.e./A)
EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOPROPYLAMINE SALT
Tolerance. Us
-------
EPA Index to Pesticide Chemicals
39AA
43AA
46AA
59AA
64AA
.49AA
Site, Dosage
and Formulation
(Ib a.e./A)
GLYPHOSATE, ISOPROPYLAMINE SALT
Tolerance. Use, Limitations
Christmas Tree Plantations (continued)
1.5-3.75 Directed spray. Perennial weed and woody brush
or control in established silvicultural sites. Ap-
3-6 Ib a.e./lOO gal plication may be made by any suitable ground
(3 Ib/gal SC/L) equipment. Thoroughly spray weed foliage, but
avoid spray contact with foliage or green bark of
desirable plants. Repeat treatments may be neces-
sary to control plants regenerating from under-
ground rhizomes or late germinating seeds.
Douglas-Fir (forest)
Fir (forest)
Hemlock (forest)
Pine (forest)
Spruce (forest)
Western Hemlock
(forest)
1.13-1.5
(3 Ib/gal SC/L)
0.75
(3 Ib/gal SC/L)
0.75-1.13
(3 Ib/gal SC/L)
General Information; Do not use over-the-top
broadcast applications in silvicultural nurseries
or Christmas tree plantations. Apply only where
conifers have been established for more than a
year. Some injury to treated conifers will result
where spray patterns overlap, or the higher dosages
are used, or when applications are made during
periods of active conifer growth. Application may
be made by air, or by any suitable ground equip-
ment.
Use limited to areas East of the crest of the Cas-
cades, except AL, AK, GA, LA, MS, NC, SC, IN, TX
and VA. Conifer release. Broadcast. Apply after •'
dormancy in fall or prior to bud swell in the
spring. In fall, apply before major leaf fall of
the undesirable deciduous species, although some
autumn colors may be present.
Use limited to areas West of the crest of the Cas-
cades. Conifer release. Broadcast. Spring ap-
plication. Apply prior to bud swell for control
of annual weeds.
Use limited to areas West of the crest of the Cas-
cades. Conifer release. Broadcast. Fall appli-
cation. Apply before leaf abscission of undesir-
able deciduous species, although some autumn colors
may be present. Use only the lower dosage on
western hemlock.
Issued: 11-01-83
1-103601-37
155
-------
EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOPROPYLAMINE SALT
Listing of Registered Pesticide Products by Formulation
3.0002 3 Ib/gal formulation intermediate
glyphosate, isopropylamine salt (103601)
000524-00339
4.0002 A Ib/gal formulation intermediate
glyphosate, isopropylamine salt (103601)
000524-00318
2.0002 62% formulation intermediate
glyphosate, isopropylamine salt (103601)
000524-00333
a.0412 1.04 Ib/gal emulsifiable concentrate
glyphosate, isopropylamine salt (103601) plus alachlor (090501)
000524-00341
'0.4215 0.42 Ib/gal soluble concentrate/liquid
glyphosate, isopropylaiaine salt (103601)
000239-02469 000769-00497 046515-00003
33.0015 3 Ib/gal soluble concentrate/liquid
glyphosate, isopropylamine salt (103601)
000524-00308 000524-00326
34.0015 4 Ib/gal soluble concentrate/liquid
glyphosate, isopropylamine salt (103601)
000524-00343
35.0015 5% soluble concentrate/liquid
glyphosate, isopropylaaine salt (103601)
007401-00306 034911-00025
06.6015 6.62 soluble concentrate/liquid
glyphosate, isopropylaoine salt (103601)
000802-00534
00.5016 0.52 liquid-ready to use
glyphosate, isopropylamine salt (103601)
000239-02467 000769-00523 000802-00535 007401-00304
007401-00307 046515-00002
"0,9616 0.96% liquid-ready to use
glyphosate, isopropylamine salt (103601)
000524-00330 000769-00537
101.0016 1% liquid-ready to use
glyphosate, isopropylamine salt (103601)
007401-00357
157
Issuedi' 11-01-83 1-103601-39
-------
EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOPROPYLAKLNE SALT
Appendix A
Listing of Common Chemical Names Used on the Entry
Chemical Common Kane
Code (source)
030029 2,4-D, dimethy1-
amine salt
100101 Bladex
101101 Metribuzin
122001 Sulfometuron methyl
EPA Acceptable
Common/Chemical Name
2,4-dichlorophenoxyacetic acid,
dimethylamine salt
2-[[4-chloro-6-(ethylamino)-s-
tr iaz in-z-y1]amino]-2-ae thyl-
propjonitrile
4-amino-6-(1,1-dimethylethyl)-3-
(methylthio)-l,2,4-triazin-5(4H)-one
methyl 2-[[[[(4,6-dimethyl-2-
pyrimidinyl)amino]-carbonyl]amino]-
sulfonyl]benzoate
Issued; l.V-01-83
-li, 601-41
159
-------
EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOPROPYLAMINE SALT
Appendix B
Listing of Registration Numbers By Site and Formulation (continued)
>001AA Barley
(3 Ib/gal SC/L)
000524-00308
!001AA Beans
73~Ib~/gal SC/L)
000524-00308
(0.962 RTU)
000524-00330
J001AA Beet Greens
(3 Ib/gal SC/L)
000524-00308
(0.96% RTU)
000524-00330
4001AA Beets (red)
(3 Ib/gal SC/L)
000524-00308
(0.96X RTU)
000524-00330
3017BA Benaudagrass (seed
crop)
(3 Ib/gal SC/L)
000524-00308
3007AA Cabbage
000524-00326
000524-00326
?,
(3 Ib/gal SC/L)
000524-00308
(0.96X RTU)
000524-00330
4003AA Carrot
(3 Ib/gal SC/L)
000524-00308
(0.96Z RTU)
0.00524-00330
Issued: 11-01-83
1-103601-43
-------
i2AA
)02AA
J14AA
006AA
EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOPROPYLAMINE SALT
Appendix B
Listing of Registration Nunbers By Site and Formulation (continued)
Gardens
-)
034911-00025
(5% SC/L)
007A01-000306
(0.5% RTU)
007401-00304
(IX RTU)
007401-00357
Grapefruit
(3 Ib/gal SC/L)
000524-00308
(0.96% RTU)
000524-00330
Grapes
(3 Ib/gal SC/L)
000524-00308
(0.96% RTU)
000524-00330
066BA Grasses Grown for
Seed
(3 Ib/gal SC/L)
000524-00308
Guava
(3 Ib/gal SC/L)
000524-00308
Horseradish
(3 Ib/gal SC/L)
000524-00308
(0.96% RTU)
000524-00330
Kale
(3 Ib/gal SC/L)
000524-00308
(0.96% RTU)
000524-00330
000524-00326
000524-00326
000524-00326
Issued: 11-01-83
1-103601-45
163
-------
EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOPROPYLAMINE SALT
Appendix B
Listing of Registration Numbers By Site and Formulation (continued)
)21AA Mustard Greens
(3 Ib/gal SC/L)
000524-00308
(0.96% RTU)
000524-00330
)03AA Nectarine
(3 Ib/gal SC/L)
000524-00308
303AA Oats
TTTb/gal SC/L)
000524-00303
)15AA Okra
(3 Ib/gal SC/L)
000524-00308
(0.962 RTU)
000524-00330
D11AA Onion
(3 Ib/gal SC/L)
000524-00308
(0.96% RTU)
000524-00330
006AA Orange
(3 Ib/gal SC/L)
000524-00308
(0.96% RTU)
000524-00330
010AA Papaya
(3 Ib/gal SC/L)
000524-00308
035AA Pastures
(3 Ib/gal SC/L)
000524-00308
004AA Peach
- (3 Ib/gal SC/L)
000524-00308
000524-00326
000524-00326
Iss-ied: 11-01-83
I-10i601-47
165
-------
I14AA
(06AA
J23AA
EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOPROPYLAMINE SALT
Appendix B
Listing of Registration Numbers By Site and Formulation (continued)
Radish
(3 Ib/gal SC/L)
000524-00308
(0.96% RTU)
000524-00330
Sorghum (Milo)
(3 Ib/gal SC/L)
000524-00308
Soybeans
(3 Ib/gal SC/L)
000524-00308
(1.04 Ib/gal EC)
000524-00341
Spinach
(3 Ib/gal SC/L)
000524-00308
(0.96% RTU)
000524-00330
302AA Sugar Beets
(3 Ib/gal SC/L)
000524-00308
(0.96% RTU)
000524-00330
fo03AA Sugarcane
(3 Ib/gal SC/L)
000524-00308
[018AA Sweet Potato
(3 Ib/gal SC/L)
000524-00308
CO.96% RTU)
000524-00330
Tangelo
(3 Ib/gal SC/L)
000524-00308
(0.96% RTU)
000524-00330
Issued: 11-01-8".
000524-00326
000524-00326
000524-00326
000524-00326
1-103601-49
167
-------
3017AA
013 AA
351AA
056AA
070AA
088AA
089AA
082AA
083AA
•093AA
EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOPROPYLAMINE SALT
Appendix B
Listing of Registration Numbers By Site and Fornulation (continued)
Bermudagrass (Coonon
and Coastal)
(3 Ib/gal SC/L)
000524-00308
031AA Boxwood
(3 Ib/gal SC/L)
000524-00308
Euonyaus
U Ib/gal SC/L)
000524-00308
Fir
73~lb/gal SC/L)
000524-00308
000524-00326
000524-00326
000524-00326
Flowering Crabapple
(3 Ib/gal SC/L)
000524-00308 000524-00326
Holly
(3 Ib/gal SC/L)
000524-00308
Ligustrum
C3 Ib/gal SC/L)
000524-00308
Lilac
(3 Ib/gal SC/L)
000524-00308
Magnolia
(3 Ib/gal SC/L)
000524-00308
Maple
TJlb/gal SC/L)
000524-00308
Oak
(3 Ib/gal SC/L)
000524-00308
:OOOOA Ornamentals
(3 Ib/gal SC/L)
000524-00308
000524-00326
000524-00326
000524-00326
000524-00326
000524-00326
000524-00326
000524-00326
169
Issued: 11-01-83
1-103601-51
-------
EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOPROPYLAMINE SALT
Appendix B
Listing of Registration Numbers By Site and Formulation (continued)
I09QA Industrial Plant
Sites, Lumberyards,
Petroleum Tank Farms
and Pumping Instal-
lations, Storage
Areas
(3 Ib/gal SC/L)
000524-00308 000524-00326
3110A Parking Areas
(3 Ib/gal SC/L)
000524-00308 000524-00326
3060A Pipeline, Power and
Telephone Rights-of-
Way_
(3 Ib/gal SC/L)
000524-00308 000524-00326
0050A Railroads
(3 Ib/gal SC/L)
000524^30308 000524-00326
I'OOOOA Uncultivated Agricul-
1 tural Areas, Farm-
stead Building Foun-
dations
(3 Ib/gal SC/L)
000524-00308 000524-00326
GREENHOUSE NON-FOOD CROP
1100
(Ornamental Plants and Forest Trees)
60A Greenhouse
(3 Ib/gal SC/L)
000524-00308
Issued: 11-01-83 1-103601-53 | J 1
-------
0110A
EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOPROPYLAMINE SALT
Appendix B
Listing of Registration Numbers By Site and Formulation (continued)
Driveways, Parking
Areas, Sidewalks
C5X SC/L)
007401-00306 034911-00025
046515-00003
(6.6% SC/L)
000802-00534
(0.42 Ib/gal SC/L)
000239-02469 000769-00497
(0.5% RTU)
000239-02467
007401-00307
(0.96% RTU)
000524-00330
(1% RTU)
007401-00357
(0.75% PrL)
000239-02466
000769-00523
046515-00002
000769-00537
000802-00535 007401-00304
70150A Fencerows
(5% SC/L)
007401-00306
(6.6% SC/L)
000802-00534
(0.42 Ib/gal SC/L)
000239-02469 000769-00497
034911-00025 046515-00003
(0.5% RTU)
000239-02467
007401-00307
(0.96% RTU)
000524-00330
(1% RTU)
007401-00357
(0.75% PrL)
000239-02466
000769-00523
046515-00002
000769-00537
000802-00535 007401-00304
Issued: 11-01-83
1-103601-55
173
-------
EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOPROPYLAMINE SALT
Appendix B
Listing of Registration Numbers By Site and Formulation (continued)
OOA Ornamental Lawns
(5% SC/L)
007401-00306 034911-00025 046515-00003
(6.6% SC/L)
000802-00534
(0.42 Ib/gal SC/L)
000239-02469 000769-00497
(0.5% RTU)
000239-02467 000769-00523 000802-00535 007401-00304
007401-00307 046515-00002
(0.96% RTU)
000524-00330 000769-00537
(0.75% PrL)
000239-02466
I010A Ornamental Trees and
Shrubs
(5% SC/L)
007401-00306 034911-00025 046515-00003
(6.6% SC/L)
000802-00534
(0.42 Ib/gal SC/L)
000239-02469 000769-00497
(0.5% RTU)
000239-02467 000769-00523 000802-00535 007401-00304
007401-00307 046515-00002
(0.96% RTU)
000524-00330 000769-00537
(1% RTU)
007401-00357
(0.75% PrL)
000239-02466
Issued: 11-01-83
1-103601-57
175
-------
EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOPROPYLAMINE SALT
Appendix B
Listing of Registration Numbers By Site and Formulation (continued)
)OOOA Storage Areas. Vacant
Lots, Yards
(5X SC/L)
007401-00306 034911-00025 046515-00003
(6.6% SC/L)
000302-00534
(0.42 Ib/gal SC/L)
000239-02469 000769-00497
(0.5% RTU)
000239-02467 000769-00523 000802-00535 007401-00304
007401-00307 046515-00002
(0.96% RTU)
000524-00330 000769-00537
(1% RTU)
007401-00357
(0.75% PrL)
000239-02466
AQUATIC FOOD CROP
(Agricultural' Crop)
004AA Rice
TTTb/gal SC/L)
000524-00308
AQUATIC NON-FOOD
(Aquatic Sites)
022MA Agricultural Drainage
Systems
;4 Ib/gal SC/L)
000524-00343
Issued: 11-01-83 1-103601-59 '
-------
OOAA
I104AA
|3064AA
EPA Index to Pesticide Chemicals
GLYPHOSATE, ISOPROPYLAMINE SALT
Appendix B
Listing of Registration Numbers By Site and Fornulation (continued)
Forest Trees
'D
000524-00326
(3 Ib/gal SC/L)
000524-0030C
I46AA Hemlock (forest)
(3 Ib/gal SC/L)
000524-00308
000524-00326
597AA Loblolly Pine
(forestT
(3 Ib/gal SC/L)
000524-00308
i359AA Pine (forest)
(3 Ib/gal SC/L)
000524-00308
M6AA Silvicultural Nur-
series
(3 Ib/gal SC/L)
000524-00308
000524-00326
000524-00326
Slash Pine (forest) '
(3 Ib/gal SC/L)
000524-00308
Spruce (forest)
(3 Ib/gal SC/L)
000524-00308
000524-00326
•CW9AA Western Hemlock
(forestT
(3 Ib/gal SC/L)
000524-00308
000524-00326
11-01-83
1-103601-61
179
-------
IV. BIBLIOGRAPHY APPENDICES
Guide to Bibliography
Bibliography
180
-------
Guide to Use of This Bibliography
CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies consid-ered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
In the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and Its predecessor agencies in support of past regulatory
decisions. Selections from other sources Including the
published literature, in those Instances where they have
been considered, will be Included.
UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single gtudy.
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 submltted(
studies; see paragraph ii(d)(U) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary Identifier number is
also to be used whenever specific reference Is needed.
FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
181
-------
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to'show a--personal author.
When no Individual was Identified, tfie 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 follow-
ing 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.
(*») Volume Identification (Accession Number). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number ia in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123^56, the
first study would be 123^56-A; the second, 123^56-B;
the 26th, 123^56-Z-, and the 27th, 123^56-AA.
182
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Glyphosate Standard
MRID CITATION
00015759 Kahrs, R.A.; Cheung, M.W. (1979) Tank Mixes of Metolachlor (8E)
plus Linuron or Metribuzin plus Glyphosate—Soybeans; Tank Mixes
of Metolachlor (8E) plus Linuron or Metribuzin plus Paraquat--
Soybeans: No and Minimum Tillage Applications: Report No. ABR-
79029. Summary of studies 237821-B through 237821-Q. (Unpub-
lished study received Mar 16, 1979 under 100-583; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:237821-A)
00015760 Kincaid, L. (1979) Metolachlor + Glyphosate + Linuron; Dual 8E +
Roundup 4E + Lorox 50W: AG-A No. 4763 I,II. (Unpublished study
including letter dated May 23, 1978 from J.D. Riggleman to Rob-
ert A. Kahrs, received Mar 16, 1979 under 100-583; prepared in
cooperation with E.I. du Pont de Nemours & Co., Inc. and ADC
Laboratories, submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:237821-B)
00015761 Schnappinger, M.G. (1979) Metolachlor + Glyphosate + Linuron; Dual
8E + Roundup 4E + Lorox 50W: AG-A No. 4886 1,11. (Unpublished
study including letter dated May 23, 1978 from J.D. Riggleman to
Robert A. Kahrs, received Mar 16, 1979 under 100-583; prepared
in cooperation with E.I. du Pont de Nemours & Co., Inc. and ADC
Laboratories, submitted by Ciba-Geigy Corp., Greensboro, N.C.:
CDL:237821-C)
00015762 Searcy, V.; Herman, D. (1979) Metolachlor + Glyphosate + Linuron;
Dual 8E + Roundup 4E + Lorox 50W: AG-A No. 4893 1,11. (Unpub-
lished study including letter dated May 23, 1978 from J.D. Rig-
gleman to Robert A. Kahrs, received Mar 16, 1979 under 100-583;
prepared in cooperation with E.I. du Pont de Nemours & Co.,
Inc. and ADC Laboratories, submitted by Ciba-Geigy Corp., ,
Greensboro, N.C.; CDL:237821-D)
00015763 Rose, W.; Worsham, D. (1979) Metolachlor + Glyphosate + Linuron;
Dual 8E + Roundup 4E + Lorox SOW: AG-A No. 4956 I,II A. (Unpub-
lished study including letter dated May 23, 1978 from J.D. Rig-
gleman to Robert A. Kahrs, received Mar 16, 1979 under 100-583;
prepared in cooperation with Rocky Mount Experiment Station, ADC
Laboratories and E.I. du Pont de Nemours & Co., Inc., submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL:237821-E)
00015764 Kincaid, L. (1979) Metolachlor (Dual(R) 8E); Glyphosate (Roundup
4E); Metribuzin (Sencor 50W): AG-A No. 4765 1,1I. (Unpublished
study including letter dated May 23, 1978 from J.D. Riggleman to
Robert A. Kahrs, received Mar 16, 1979 under 100-583; prepared
in cooperation with ADC Laboratories and E.I. du Pont de Nemours
& Co., Inc., submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:237821-F)
-1- 183
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Glyphosate Standard
MRID CITATION
00015765 Schnappinger, M.G. (1978) MetolachloY (Dual 8E) ; Glyphosate (Round-
up 4E); Metribuzln (Sencor 50W): AG-A No. 4887 1,1 I. (Unpub-
lished study including letter dated May 23, 1978 from J.D.
Riggleman to Robert Kahrs, received Mar 16, 1979 under 100-583;
prepared in cooperation with ADC Laboratories and E.I. du Pont
de Nemours & Co., Inc., submitted by Ciba-Geigy Corp., Greens-
boro, N.C.; CDL:237821-G)
00015766 Searcy, S. ; Herman, D. (1979) Metolachlor (Dual 8E) ; Glyphos-
ate (Roundup 4E); Metribuzin (Sencor 50W) : AG-A No. 4895 I, II.
(Unpublished study including letter dated May 23, 1978 from J.D.
Riggleman to Robert A. Kahrs, received Mar 16, 1979 under 100-
583; prepared in cooperation with ADC Laboratories and E.I. du
Pont de Nemours & Co., Inc., submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:237821-H)
00015767 Rose, W.; Worsham, D. (1979) Metolachlor (Dual 8E); Glyphos-
ate (Roundup 4E); Metribuzin (Sencor 50W) : AG-A No. 4958 I, II A.
(Unpublished study including letter dated May 23, 1978 from J.D.
Riggleman to Robert A. Kahrs, received Mar 16, 1979 under 100-
583; prepared in cooperation with ADC Laboratories and E.I. du
Pont de Nemours & Co., Inc., submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:237821-I)
00023336 Monsanto Company (1974) Residues of Glyphosate, Atrazine and Sima-
zine in or on Field Corn Grain, Sweet Corn and Corn Forage and
Fodder following a Tank Mix, Pre-emergent, Minimum Till Applica-
tion of Roundup, Atrazine and Simazine. (Unpublished study re-
ceived Dec 19, 1977 under 524-308; CDL:232518-B)
00023512 Houseworth, L.D.; Schnappinger, H.G.; Slagowski, J.L.; et al .
(1979) Tank Mixes of Metolachlor (6E, 8E) plus Simazine and/or
Atrazine plus Paraquat or Glyphosate— Corn: Summary of Residue
Data: Report No. ABR-79105. (Unpublished study received Dec 10,
1979 under 100-583; prepared in cooperation with Chevron Chem-
ical Co. and others, submitted by Ciba-Geigy Corp., Greensboro,
N.C.; CDL:241647-A)
00024503 Monsanto Company (1974) Summary of Residue Data. (Unpublished
study received Jan 16, 1978 under 524-285; CDL:232680-B)
00027235 Monsanto Company (1979) Analytical Residue Method for N-Phosphono-
methylglycine (Glyphosate) and Aminomethylphosphonic acid in
Sugarcane, Bagasse, Raw Sugar and Molasses. (Unpublished study
received Dec 28, 1979 under 524-332; CDL:099157-B)
184
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Glyphosate Standard
MR ID CITATION
V
00028852 Monsanto Company (1976) Glyphosate Residues in Peanuts following
Preemergent Treatment with Roundup Herbicide. (Unpublished
study received Feb 22, 1980 under 524-308; CDL:099306-A)
00028853 Monsanto Company (19??) Analytical Residue Method for N-(Phosphono-
methyl) glycine, Aminomethylphosphonic acid and N-Nitroso-N-
(phosphonomethyl) glycine in Peanuts. (Unpublished study re-
ceived Feb 22, 1980 under 524-308; CDL:099306-B)
00033954 Monsanto Company (1973) Summary and Conclusion: Residue Data.
(Unpublished study received Dec 30, 1975 under 524-308; CDL:
224062-A)
00036222 Monsanto Company (1974) Analytical Residue Method for N-Phosphono-
methyl glycine and Aminomethylphosphonic acid in Soil and Water.
Method B dated Nov 21, 1974. (Unpublished study received Sep
25, 1975 under 6G1679; CDL:095356-A)
00036223 Monsanto Company (1974) Analytical Residue Method for N-Phosphono-
methyl glycine and Aminomethylphosphonic acid in Forage and
Grain. Method B dated Mar 1, 1974. (Unpublished study received
Sep 25, 1975 under 6G1679; CDL:095356-B)
00036229 Kramer, R.M.; Beasley, R.K.; Steinmetz, J.R.; et al. (1975) Interim
Report on CP 67573, Residue and Metabolism. Part 28: Determina-
tion of Residues of Glyphosate and Its Metabolite in Fish: Agri-
cultural Research Report No. 378. (pp. 1-13 only; unpublished
study received Sep 25, 1975 under 6G1679; submitted by Monsanto
Co., Washington, D.C.; CDL:095356-I)
00036231 Monsanto Company (1975) Analytical Residue Method for N-Phosphono-
methylglycine and Aminomethylphosphonic acid in Fish Tissue.
Method dated Sep 2, 1975. (Unpublished study received Sep 25,
1975 under 6G1679; CDL:095356-K)
00036328 Fink, R. (1975) Final Report: One Generation Reproduction Study-
Mallard Duck: Project No. 139-101. (Unpublished study received
Sep 26, 1975 under 6G1679; prepared by Truslow Farms, Inc.,
submitted by Monsanto Co., Washington, D.C.; CDL:096483-N)
00037687 Monsanto Company (1976) Residues of Glyphosate, Alachlor and Cyana-
zine in or on Field Corn Forage, Fodder, and Grain following a
Tank Mix, Pre-emergent, Minimum Till Application of Round-
up, Lasso and Blades. (Unpublished study received Apr
18, 1979 under 524-285; CDL:238167-B)
-3- 185
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Glyphosate Standard
MRID CITATION
00037688 Monsanto Company (1979) Analytical Residue Method for N-Phosphono-
methyl Glycine, Aminomethylphosphonic acid and N-Nitrosogly-
phosate in Field Corn Forage, Fodder and Grain. Method dated
Jan 22, 1979. (Unpublished study received Apr 18, 1979 under
524-285; CDL:238167-C)
00038770 Cowell, J.E.; Taylor, A.L.; Stranz, J.L.; et al. (1974) Final Re-
port on CP 67563, Residue and Metabolism: Part 21: Determination
of CP 67573 and CP 50435 Residues in Grapes: Agricultural Re-
search Report No. 337. Includes undated method entitled: Round-
up and metabolite residue analytical method. (Unpublished study
received Oct 4, 1974 under 5F1560; submitted by Monsanto Co.,
Washington, D.C.; CDL:094261-A)
00038771 Rueppel, M.L.; Suba, L.A.; Moran, S.J.; et al. (1974) Final Report
on CP 67573, Residue and Metabolism: Part 20: The Metabolism of
CP 67573 in Grape Plants: Agricultural Research Report No. 335.
(Unpublished study received Oct 4, 1974 under 5F1560; submitted
by Monsanto Co., Washington, D.C.; CDL:094261-B)
00038908 Beasley, R.K.; Daniels, R.J.; Lauer, R.; et al. (1974) Final Report
on CP 67573, Residue and Metabolism—Part 17: Determination of
Crop Residues in Corn, Wheat, Soybeans, Small Grains, Soil and
Water: Agricultural Research Report No. 325. (Unpublished study
received Jan 31, 1977 under 524-308; submitted by Monsanto Co.,
Washington, D.C.; CDL:095787-B)
00038979 Cowell, J.E.; Taylor, A.L.; Stranz, J.L.; et al. (1974) Roundup and
Metabolite Residue Analytical Method. (Unpublished study re-
ceived 1974 under 5G1561; submitted by Monsanto Co., Washington,
D.C.; CDL:094264-B)
00039141 Sutherland, M.L.; Marvel, J.T.; Banduhn, M.C.; et al. (1975) Sum-
mary of Metabolism Studies of Glyphosate in Citrus Plants. (Un-
published study received Jan 26, 1976 under 524-308; submitted
by Monsanto Co., Washington, D.C.; CDL:094958-B)
00039142 Beasley, R.K.; Kramer, R.M.; Carstarphen, B.A.; et al. (1975) Sum-
mary of Glyphosate (Roundup) Residue Studies in Citrus Fruits
and Processed Fractions. (Unpublished study received Jan 26,
1976 under 6G1734; submitted by Monsanto Co., Washington, D.C.;
CDL:095065-A)
00039377 Conkin, R.A.; Hannah, L.H.; Stewart, E.R. (1975) Residue Data for
Roundup on Rice and in Fish. (Unpublished study received Sep
26, 1975 under 6H5106; submitted by Monsanto Co., Washington
D.C.; CDL:094900-C)
-4-
186
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Glyphosate Standard
MRID CITATION
00039381 Kramer, R.M.; Arras, D.D.; Beasley,VR.K.; et al. (1975) Final Re-
port on CP 67573 Residue and Metabolism: Agricultural Research
Report No. 372. (Unpublished study received Sep 25, 1975 under
6G1679; prepared in cooperation with Washington State Univ. and
others, submitted by Monsanto Co., Washington, D.C.; CDL:
095355-A)
00040083 Monsanto Company (1975) Storage Stability of Field Residue Samples
and Glyphosate-14C Treated Crops. (Unpublished study received
Aug 13, 1975 under 5F1536; CDL:094866-A)
00040084 Monsanto Company (1975) Glyphosate Residues in Soybeans. (Unpub-
lished study received Aug 13, 1975 under 5F1536; CDL:094866-B)
00040085 Monsanto Company (1975) Glyphosate Residues in Corn. (Unpub-
lished study received Aug 13, 1975 under 5F1536; CDL:094866-C)
00040086 Monsanto Company (1975) Glyphosate Residues in Wheat Grain.
(Unpublished study received Aug 13, 1975 under 5F1536; CDL:
094866-D)
00040087 Monsanto Company (1975) Glyphosate Residues in Small Grains.
(Unpublished study received Aug 13, 1975 under 5F1536; CDL:
094866-E)
00044422 Monsanto Company (19??) Summary and Conclusions: Roundup on
Barley, Buckwheat, Oats, Rice, Rye and Sorghums. (Unpublished
study received on unknown date under 5G1523; CDL:094036-B)
00044423 Monsanto Company (1974) Analytical Residue Method for N-Phosphono-
methyl glycine and Aminomethylphosphonic acid in Forage and
Grain. Method dated Mar 1, 1974. (Unpublished study received
on unknown date under 5G1523; CDL:094036-C)
00044426 Monsanto Company (1973) Roundup Metabolite in Various Grains.
(Unpublished study received on unknown date under 5G1523, CDL:
094155-F)
00046362 Rodwell, D.E.; Tasker, E.J.; Blair, A.M.; et al. (1980) Teratology
Study in Rats: IRDC No. 401-054. (Unpublished study including
IRDC no. 999-021; received May 23, 1980 under 524-308; prepared
by International Research and Development Corp., submitted by
Monsanto Co., Washington, D.C.; CDL:242516-A)
-5-
187
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Glyphosate Standard
MRID CITATION
00046363 Rodwell, D.E.; Tasker, E.J.; Blair,vM.; et al. (1980) Teratology
Study in Rabbits: IRDC No. 401-056. (Unpublished study received
May 23, 1980 under 524-308; prepared by International Research
and Development Corp., submitted by Monsanto Co., Washington,
D.C.; CDL:242516-B)
00048284 Monsanto Company (1973) Residue Data. (Compilation; unpublished
study received on unknown date under 524-EX-21; CDL:223373-E)
00051980 Monsanto Company (1975) Residue Results. (Unpublished study re-
ceived Jun 3, 1976 under 524-308; CDL:096177-D)
00051982 Monsanto Company (1976) Analytical Residue Method for N-Phosphono-
methylglycine and Aminomethylphosphonic acid in Green Coffee
Beans. Method dated May 1, 1976. (Unpublished study received
Jun 3, 1976 under 524-308; CDL:096177-F)
00051983 Malik, J.M.; Curtis, T.S.; Marvel, J.T. (1975) Final Report on CP-
67573, Residue and Metabolism; Part 24: The Metabolism of CP-
67573 in Coffee Plants: Agricultural Research Report No. 344.
(Unpublished study received Jun 3, 1976 under 524-308; submitted
by Monsanto Co., Washington, D.C.; CDL:096177-I)
00053005 Beasley, R.K.; Steinmetz, J.R.; Taylor, A.L.; et al. (1977) Ana-
lytical Residue Method for N-Phosphonomethyl glycine and Amino-
methylphosphonic acid in Forage Legumes and Grasses: Report
No. MSL-0061. Method dated Jun 28, 1977. (Unpublished study
received Sep 16, 1980 under 524-308; submitted by Monsanto Co.,
Washington, D.C.; CDL:099625-B)
00059050 Interregional Research Project Number 4 (1978) Summary of Glypho-
sate Residues in Guava. (Unpublished study received Nov 19,
1980 under 1E2443; CDL:099739-A)
00060103 Baszis, S.R.; Cowe11, J.; Lottman, M.; et al. (1980) Glyphosate
Residues in Cotton following Topical Treatment with Roundup
Herbicide: Report No. MSL-1283. Final rept. Includes method
dated Aug 12, 1980 entitled: Analytical residue method for N-
(Phosphonomethyl)glycine, Aminomethylphosphonic acid and N-Ni-
troso-N-(Phosphonomethyljglycine in forages and grains. (Unpub-
lished study received Nov 12, 1980 under 524-EX-54; submitted by
Monsanto Co., Washington, D.C.; CDL:099720-A)
00061555 Monsanto Company (1974) Residue Results. (Unpublished study re-
ceived on unknown date under 524-EX-24; CDL:095345-J)
-6-
188
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Glyphosate Standard
MRID CITATION
00061559 Monsanto Company (19??) Analytical Residue Method for N-Phosphono-
methyl glycine (Glyphosate) and Aminomethylphosphonic acid in
Sugarcane, Sugarcane Leaves, Bagasse, Sugar and Molasses, Irri-
gation Water and Soil. (Unpublished study received Mar 11, 1976
under 524-308; CDL:095141-E)
00063713 Monsanto Company (1979) Summary of Glyphosate Residues in Papaya.
(Unpublished study received Nov 20, 1980 under 524-308; CDL:
099751-A)
00063714 Monsanto Company (1979) Analytical Residue Method for N-Phosphono-
methylglycine and Aminomethylphosphonic acid in Papaya: Project
No. 5064. (Unpublished study received Nov 20, 1980 under 524-
308; CDL:099751-B)
00065751 Monsanto Company (1966?) Analytical Residue Method for N-(Phospho-
nomethyl)-glycine, Aminomethylphosphonic Acid and N-Nitroso-N-
(phosphonomethyl)-glycine in Forages, Grains, Soil and Water.
Undated method 1. (Unpublished study received May 12, 1977 un-
der 524-308; CDL:229787-C)
00065752 Monsanto Company (1966?) Analytical Residue Method for N-(Phospho-
nomethyl)-glycine, Aminomethylphosphonic Acid and N-Nitroso-N-
(phosphonomethyl)-glycine in Forages, Grains and Water. Undated
method 2. (Unpublished study received May 12, 1977 under 524-
308; CDL:229787-D)
00065753 Frazier, H.W.; Rueppel , M.L. (1976) Crop Metabolism Studies of N-
(Phosphonomethyl)-glycine: N-Nitrosoglyphosate: Report No. 477.
Interim rept. (Unpublished study received May 12, 1977 under
524-308; submitted by Monsanto Co., Washington, D.C.; CDL:
229787-E)
00067039 Birch, M.D. (1970) Toxicological Investigation of CP 67573-3:
Project No. Y-70-90. (Unpublished study received Jan 30, 1973
under 524-308; prepared by Younger Laboratories, Inc., submitted
by Monsanto Co., Washington, D.C.; CDL:008460-C)
00067425 Monsanto Company (1980) Residues of Glyphosate and Other Herbicides
in Wheat following Chemical Fallow Applications of Roundup
Tank Mix Combinations. Includes method dated Jul 1, 1979 and
undated methods entitled: 2,4-D in wheat forage, straw and
grain; Dicamba in wheat forage, straw and grain; Residues of
alachlor in wheat grain, forage and straw; Atrazine in wheat
forage, straw and grain; Cyanazine in wheat forage, straw and
grain; Metribuzin and metabolites in wheat forage, straw and
grain. (Unpublished study, including published data, received
Dec 29, 1980 under 524-308; CDL:243990-A; 243991)
189
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Glyphosate Standard
MRID CITATION
00070893 LeBlanc, G.A.; Surprenant, D.C.; Slight, B.H., III (1980) Acute
Toxicity of Roundup to the Water Flea (Daphnia magna):
Report #BW-80-4-636; Monsanto Study No. BN-80-079. (Unpublished
study, including letter dated Feb 21, 1980 from R. Oleson to
Robert B. Foster, received Apr 2, 1981 under 524-308; prepared
by EG & G, Bionomics, submitted by Monsanto Co., Washington,
D.C.; CDL:244749-B)
00070895 LeBlanc, G.A.; Surprenant, D.C.; Sleight, B.H., III (1980) Acute
Toxicity of Roundup to Rainbow Trout (Salmo gairdneri):
Report #BW-80-4-635; Monsanto Study No. BN-80-074. (Unpublished
study received Apr 4, 1981 under 524-308; prepared by EG & G,
Bionomics, submitted by Monsanto Co., Washington, D.C.; CDL:
244749-D)
00070897 LeBlanc, G.A.; Surprenant, D.C.; Sleight, B.H., III (1980) Acute
Toxicity of Roundup to Bluegill (Lepomis macrochirus):
Report #BW-80-4-634; Monsanto Study No. BN-80-075. (Unpublished
study received Apr 2, 1981 under 524-308; prepared by EG & G,
Bionomics, submitted by Monsanto Co., Washington, D.C.; CDL:
244749-F)
00076491 Sleight, B.H., III (1973) Research Report Submitted to Monsanto
Company: Exposure of Fish to 14C-Roundup: Accumulation,
Distribution, and Elimination of 14C-Residues. (Unpublished
study received Nov 9, 1973 under 524-308; prepared by Bionomics,
Inc., submitted by Monsanto Co., Washington, D.C.; CDL:120640-B)
00076492 Fink, R. (1973) Final Report: Eight-day Dietary LC50—Bobwhite
Quail: Project No. 241-106. (Unpublished study received Nov 9,
1973 under 524-308; prepared by Environmental Sciences Corp.,
submitted by Monsanto Co., Washington, D.C.; CDL:120640-D)
00076805 Baszis, S.R.; Serdy, F.S.; Dubelman, S. (1980) Glyphosate Residues
in Pasture Grasses, Legumes and Alfalfa following Postemergent
Spot Treatment with Roundup Herbicide: Report No. MSL-1140.
Includes method dated Jul 1, 1979. (Unpublished study received
May 11, 1981 under 524-308; submitted by Monsanto Co., Wash-
ington, D.C.; CDL:070083-A)
0007722" Branch, O.K.; Stout, L.D.; Folk, R.M. (1981) Acute Dermal Toxicity
of Mon 2139 NF-80-W to Rabbits: EHL 800295. (Unpublished
study received Jul 1, 1981 under 524-308; submitted by Monsanto
Co., Washington, D.C.; CDL:070170-G)
00077228 Branch, O.K.; Stout, L.D.; Folk, R.M. (1981) Primary Eye Irrita-
tion of MON 2139 NF-80-W to Rabbits: EHL 800297. (Unpublished
study received Jul 1, 1981 under 524-308; submitted by Monsanto
Co., Washington, D.C.; CDL:070170-H) ,
-8-
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Glyphosate Standard
MRID CITATION
00077229 Branch, O.K.; Stout, L.D.; Folk, R.M. (1981) Primary Skin Irri-
tation of MON 2139 NF-80-W to Rabbits: EHL 800296. (Unpub-
lished study received Jul 1, 1981 under 524-308; submitted
by Monsanto Co., Washington, D.C.; CDL:070170-I)
00077230 Branch, O.K.; Stout, L.D.; Folk, R.M. (1981) Acute Oral Toxicity of
MON 2139 NF-80-AA to Rats: EHL 800290. (Unpublished study
received Jul 1, 1981 under 524-308; submitted by Monsanto Co.,
Washington, D.C.; CDL:070170-J)
00077231 Branch, O.K.; Stout, L.D.; Folk, R.M. (1981) Acute Dermal Toxicity
of MON 2139 NF-80-AA to Rabbits: EHL 800291. (Unpublished
study received Jul 1, 1981 under 524-308; submitted by Monsanto
Co., Washington, D.C.; CDL:070170-K)
00077232 Branch, O.K.; Stout, L.D.; Folk, R.M. (1981) Primary Eye Irrita-
tion of MON 2139 NF-80-AA to Rabbits: EHL 800293. (Unpublished
study received Jul 1, 1981 under 524-308; submitted by Monsanto
Co., Washington, D.C.; CDL:070170-L)
00077233 Branch, O.K.; Stout, L.D.; Folk, R.M. (1981) Primary Skin Irri-
tation of MON 2139 NF-80-AA to Rabbits: EHL 800292. (Unpub-
lished study received Jul 1, 1981 under 524-308; submitted
by Monsanto Co., Washington D.C.; CDL:070170-M)
00077234 Branch, O.K.; Stout, L.D.; Folk, R.M. (1981) Acute Oral Toxicity
of Mon 0139 to Rats: EHL 800257. (Unpublished study received
Jul 1, 1981 under 524-308; submitted by Monsanto Co., Wash-
ington, D.C.; CDL:070170-N)
00077235 Branch, O.K.; Stout, L.D.; Folk, R.M. (1981) Acute Dermal Toxicity
of MON 0139 to Rabbits: EHL 800258. (Unpublished study re-
ceived Jul 1, 1981 under 524-308; submitted by Monsanto Co.,
Washington, D.C.; CDL:070170-0)
00077236 Branch, O.K.; Stout, L.D.; Folk, R.M. (1981) Primary Eye Irrita-
tion of MON 0139 to Rabbits: EHL 800260. (Unpublished study
received Jul 1, 1981 under 524-308; submitted by Monsanto Co.,
Washington, D.C.; CDL:070170-P)
00077237 Branch, O.K.; Stout, L.D.; Folk, R.M. (1981) Primary Skin Irri-
tation of MON 0139 to Rabbits: EHL 800259. (Unpublished study
received Jul 1, 1981 under 524-308; submitted by Monsanto Co.,
Washington, D.C.; CDL:070170-Q)
191
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Glyphosate Standard
MRID CITATION
00077238 Dubelman, S.; Steinmetz, J.R. (198l) Glyphosate Residues in Water
following Application of Roundup Herbicide to Flowing Bod-
ies of Water: MSL-1486. Final rept. Includes method dated
Sep 4, 1980. (Unpublished study received Jul 1, 1981 under
524-308; prepared in cooperation with Analytical Biochemistry
Labs, submitted by Monsanto Co., Washington D.C.; CDL:070170-R)
00077301 Monsanto Company (1975) Residue Results. (Compilation; unpublished
study, including published data, received Mar 11, 1976 under
524-308; CDL:095141-A)
00078619 Shirasu, Y.; Moriya, M.; Ohta, T. (1978) Microbial Mutagenicity
Testing on CP67573 (Glyphosate). (Unpublished study received
Apr 25, 1979 under 524-308; prepared by Institute of Environ-
mental Toxicology, Japan, submitted by Monsanto Co., Washington,
D.C.; CDL:238233-A)
00078620 Kier, L.D.; Flowers, L.J.; Hannah, L.H. (1978) Final Report on
Salmonella Mutagenicity Assay of Glyphosate: Test No. LF-78-161.
(Unpublished study received Apr 25, 1979 under 524-308; sub-
mitted by Monsanto Co., Washington, D.C.; CDL:238233-B)
00078655 Thompson, C.M.; Griffen, J.; Boudreau, P. (1980) Acute Toxicity of
MON 2139 NF-80W (AB-80-363) to Rainbow Trout (Salmo gairdne-
ri): Static Acute Bioassay Report #26316. (Unpublished
study received Jul 1, 1981 under 524-308; prepared by Analytical
Bio Chemistry Laboratories, Inc., submitted by Monsanto Co.,
Washington, D.C.; CDL:070171-B)
00078656 Thompson, C.M.; Griffen, J.; (1980) Acute Toxicity of MON 2139 NF-
80W (AB-80-364) to Bluegill Sunfish (Lepomis macrochirus):
Static Acute Bioassay Report #26315. (Unpublished study re-
ceived Jul 1, 1981 under 524-308; prepared by Analytical Bio
Chemistry Laboratories, Inc., submitted by Monsanto Co., Wash-
ington, D.C.; CDL:070171-C)
00078657 Forbis, A.D.; Boudreau, P. (1980) Acute Toxicity of MON 2139-NF-80W
(AB-80-365) to Daphnia magna: Static Acute Bioassay Report
#26317. (Unpublished study received Jul 1, 1981 under 524-308;
prepared by Analytical Bio Chemistry Laboratories, Inc., submit-
ted by Monsanto Co., Washington, D.C.; CDL-.070171-D)
00078658 Thompson, C.M.; Griffen, J.; Forbis, A.D. (1980) Acute Toxicity of
MON 2139 NF-80-AA (AB-80-367) to Rainbow Trout (Salmo gaird-
neri): Static Acute Bioassay Report #26319. (Unpublished
study received Jul 1, 1981 under 524-308; prepared by Analytical
Bio Chemistry Laboratories, Inc., submitted by Monsanto Co.,
Washington, D.C.; CDL:070171-E)
1 92
-10- ' *-
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Glyphosate Standard
MRID CITATION
V
00078659 Thompson, C.M.; Griffen, J. (1980) Acute Toxicity of MON 2139-NF-
80-AA (AB-80-368) to Bluegill Sunfish (Lepomis macrochirus):
Static Acute Bioassay Report #26318. (Unpublished study re-
ceived Jul 1, 1981 under 524-308; prepared by Analytical Bio
Chemistry Laboratories, Inc., submitted by Monsanto Co., Wash-
ington, D.C.; CDL:070171-F)
00078660 Boudreau, P.; Forbis, A.D. (1980) The Acute Toxicity of MON 2139
NF-80-AA (AB-80-369) to Daphnia magna: Static Acute Bioassay
Report #26320. (Unpublished study received Jul 1, 1981 under
524-308; prepared by Analytical Bio Chemistry Laboratories,
Inc., submitted by Monsanto Co., Washington, D.C.; CDL:070171-G)
00078661 Thompson, C.M.; Griffen, J. (1981) Acute Toxicity of MON 0139 (Lot
LURT 12011) (AB-81-072) to Rainbow Trout (Salmo gairdneri):
Static Acute Bioassay Report #27202. (Unpublished study re-
ceived Jul 1, 1981 under 524-308; prepared by Analytical Bio
Chemistry Laboratories, Inc., submitted by Monsanto Co., Wash-
ington, D.C.; CDL:070171-H)
00078662 Griffen, J.; Thompson, C.M. (1981) Acute Toxicity of MON 0139 (Lot
LURT 12011) (AB-81-073) to Bluegill Sunfish (Lepomis macro-
chirus): Static Acute Bioassay Report #27201. (Unpublished
study received Jul 1, 1981 under 524-308; prepared by Analytical
Bio Chemistry Laboratories, Inc., submitted by Monsanto Co.,
Washington, D.C.; CDL:070171-I)
00078663 Forbis, A.D.; Boudreau, P. (1981) Acute Toxicity of MON 0139 (Lot
LURT 12011) (AB-81-074) to Daphnia magna: Static Acute Bio-
assay Report #27203. (Unpublished study received Jul 1, 1981
under 524-308; prepared by Analytical Bio Chemistry Laborato-
ries, Inc., submitted by Monsanto Co., Washington, D.C.; CDL:
070171-J)
00078664 Thompson, C.M.; Griffen, J. (1980) Acute Toxicity of MON-0139-X-77
(AB-80-262) to Rainbow Trout (Salmo gairdneri): Static Acute
Bioassay Report #26020. (Unpublished study received Jul 1, 1981
under 524-308; prepared by Analytical Bio Chemistry Laborato-
ries, Inc., submitted by Monsanto Co., Washington, D.C.; CDL:
070171-K)
00078665 Thompson, C.M.; Griffen, J. (1980) Acute Toxicity of MON-0139-X-77
(AB-80-263) to Bluegill Sunfish (Lepomis macrochirus):
Static Acute Bioassay Report #26019. (Unpublished study re-
ceived Jul 1, 1981 under 524-308; prepared by Analytical Bio
Chemistry Laboratories, Inc., submitted by Monsanto Co., Wash-
ington, D.C.; CDL:070171-L)
-11-
193
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Glyphosate Standard
MRID CITATION
00078666 Forbis, A.D.; Boudreau, P. (1980) Acute Toxicity of MON-0139-X-77
(AB-80-264) to Daphnia magna: Static Acute Bioassay Report
#26021. (Unpublished study received Jul 1, 1981 under 524-308;
prepared by Analytical Bio Chemistry Laboratories, Inc., submit-
ted by Monsanto Co., Washington, D.C.; CDL:070171-M)
00078823 Monsanto Company (1978) Glyphosate Residues in Tea Leaves following
Postemergent Directed Treatment with Roundup Herbicide:
MSL-0908. (Unpublished study received Jun 17, 1981 under 524-
308; CDL:245567-A)
00078824 Monsanto Company (1980) Glyphosate Residues in Brewed and Instant
Tea following Postemergent Directed Treatment in Tea Plantations
with Roundup Herbicide: MSL-1582. (Unpublished study re-
ceived Jun 17, 1981 under 524-308; CDL:245567-B)
00081674 Schroeder, R.E.; Hogan, G.K. (1981) A Three-generation Reproduction
Study with Glyphosate in Rats: Project No. 77-2063. (Unpub-
lished study received Sep 22, 1981 under 524-308; prepared by
Bio/dynamics, Inc., submitted by Monsanto Co., Washington, D.C.;
CDL:245909-A)
00093879 Lankas, G.R.; Hogan, G.K. (1981) A Lifetime Feeding Study of
Glyphosate (Roundup Technical) in Rats: Project No. 77-
2062. (Unpublished study received J.an 20, 1982 under 524-308;
prepared by Bio/dynamics, Inc., submitted by Monsanto Co.,
Washington, D.C.; CDL:246617-A; 246618; 246619; 246620; 246621)
00094971 Grabiak, M.C.; Malik, J.M.; Purdum, W.R. (1981) A Reinvestigation
of the Static Exposure of Channel Catfish to 14C-Labeled Gly-
phosate, N-(Phosphonomethyl) Glycine: Report No. MSL-2056. (Un-
published study, including final bioconcentration report no.
27497, received Mar 2, 1982 under 524-308; submitted by Monsanto
Co., Washington, D.C.; CDL:246876-A)
00098460 Johnson, D.E.; Nair, K.P.C.; Riley, J.H.; et al. (1982) 21-day
Dermal Toxicity Study in Rabbits: 401-168; Monsanto No. IR-81-
195. (Unpublished study received Apr 12, 1982 under 524-308;
prepared by International Research and Development Corp., sub-
mitted by Monsanto Co., Washington, D.C.; CDL:247228-A)
00105995 Street, R. (1982) Letter sent to R. Taylor dated Jul 6, 1982:
Roundup herbicide: Addendum to pathology report for a three-
generation reproduction study in rats with glyphosate. (Unpub-
lished study received Jul 7, 1982 under 524-308; submitted by
Monsanto Co., Washington, DC; CDL:247793-A)
-12-
194
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Glyphosate Standard
MRID CITATION
00108097 Rueppel, M.; Suba, L.; Conoyer, M.;vet al. (1973) Final Report on
CP 67573, Residue and Metabolism: Part 10: The Metabolism of
CP 67573 in Soybeans, Cotton, Wheat, and Corn: Agricultural
Research Report No. 304. (Unpublished study received Nov 12,
1973 under 4G1444; submitted by Monsanto Commerical Products
Co., St. Louis, MO; CDL:093849-B)
00108098 Colvin, L.; Miller, J.; Marvel, J. (1973) Final Report on CP 67573
Residue and Metabolism: Part 8: The Gross Metabolism of ... (CP
67573-14C) in the Laboratory Rat following a Single Dose: Agri-
cultural Research Report No. 297. (Unpublished study received
Nov 12, 1973 under 4G1444; submitted by Monsanto Commercial
Products Co., St. Louis, MO; CDL:093849-C)
00108099 Colvin, L.; Miller, J.; Marvel, J. (1973) Final Report on CP 67573
Residue and Metabolism: Part 9: The Gross Distribution of ... CP
67573-14C in the Rabbit: Agricultural Research Report No. 298.
(Unpublished study received Nov 12, 1973 under 4G1444; sub-
mitted by Monsanto Commercial Products Co., St. Louis, MO; CDL:
093849-D)
00108100 Colvin, L.; Moran, S.; Miller, J.; et al. (1973) Final Report on
CP 67573 Residue and Metabolism: Part 11: The Metabolism of
... CP 50435-14C in the Laboratory Rat: Agricultural Research
Report No. 303. (Unpublished study received Nov 12, 1973 under
4G1444; submitted by Monsanto Commercial Products Co., St.
Louis, MO; CDL:093849-E)
00108101 Moran, S.; Colvin, L.; Rueppel, M.; et al. (1973) Final Report on
CP 67573 Residue and Metabolism: Part 12: The Isolation and
Identification of the Metabolites of CP 67573-14C Excreted by
the Laboratory Rat: Agricultural Research Report No. 306. (Un-
published study received Nov 12, 1973 under 4G1444; submitted
by Monsanto Commercial Products Co., St. Louis, MO; CDL:
093849-F)
00108107 Fink, R. (1973) Final Report: Eight-day Dietary LC50—Mallard
Ducks: Technical CP67573: Project No. 241-107. (Unpublished
study received Jul 12, 1974 under 5F1536; prepared by Environ-
mental Sciences Corp., submitted by Monsanto Co., Washington,
DC; CDL:094171-I)
00108110 Bentley, R. (1973) Acute Toxicity of Roundup (Technical) to Atlan-
tic Oyster (Crassostrea virginica). (Unpublished study received
Jul 12, 1974 under 5F1536; prepared by Bionomics, Inc., sub-
mitted by Monsanto Co., Washington, DC; CDL:094171-L)
-13-
195
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Glyphosate Standard
MRID CITATION
00108111 Bentley, R. (1973) Acute Toxicity of Roundup (Technical) to Grass
Shrimp (Palaemonetas vulgaris) and Fiddler Crab (Uca pagilator).
(Unpublished study received Jul 12, 1974 under 5F1536; prepared
by Bionomics, Inc., submitted by Monsanto, Co., Washington, DC;
CDL:094171-M)
00108115 Lauer, R.; Cowell, J.; Stranz, J.; et al. (1974) Final Report on
CP 67573, Residue and Metabolism: Part 18: Determination of Res-
idues in Meat, Milk and Eggs: Agricultural Research Report
No. 326. (Unpublished study received Jul 12, 1974 under 5F1536;
submitted by Monsanto Co., St. Louis, MO; CDL:094180-A)
00108116 Colvin, L.; Miller, J.; Marvel, J. (1973) Final Report on CP 67573
Residue and Metabolism: Part 13: The Dynamics of Accumulation
and Depletion of Orally Ingested N-Phosphonomethylglycine-14C:
Agricultural Research Report No. 309. (Unpublished study re-
ceived Jul 12, 1974 under 5F1536; submitted by Monsanto Co.,
St. Louis, MO; CDL:094180-C)
00108129 Monsanto Co. (1976) Residue Studies and Methods of Analysis for Use
of Glyphosate in Pome Fruit Orchards. (Compilation; unpublished
study reeived Sep 7, 1976 under 524-308; CDL:095269-C)
00108132 Cowell, J.; Lottman, C.; Cable, M.; et al. (1976) Determination
of Roundup Herbicide Residues in Raisins: Report No. 440. Final
rept. (Unpublished study received Jan 11, 1977 under 524-308;
submitted by Monsanto Co., Washington, DC; CDL:095703-A)
00108133 Monsanto Co. (1976) Residue Studies in Green and Dry Alfalfa:
Metabolism Studies in Pasture Crops: Glyphosate. (Compila-
tion; unpublished study received Jan 11, 1977 under 524-308;
CDL:095704-A)
00108140 Monsanto Co. (1975) Glyphosate Residue and Metabolism Studies in
Sugarcane and Soils. (Compilation; unpublished study received
Jul 1, 1976 under 6G1826; CDL:095972-B)
00108144 Monsanto Co. (1977) Study: Residue and Metabolism Analyses of
Roundup on Specific Foodstuffs. (Compilation; unpublished
study received Feb 14, 1978 under 524-EX-44; CDL:096321-A)
00108147 Monsanto Co. (1977) Residue and Metabolism: Roundup on Forage
Grasses, Legumes and Pasture Crops. (Unpublished study re-
ceived May 9, 1978 under 524-308; CDL:097094-B)
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196
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Glyphosate Standard
MRID CITATION
V
00108149 Cowell, J.; Jordan, L.; Kramer, R.; et al. (1976) Glyphosphate Res-
idues in Avocados following Post-directed Treatments with Round-
up Herbicide: Report No. 447. Final rept. (Unpublished study
received Nov 15, 1977 under 524-308; prepared in cooperation
with Univ. of California—Riverside, Dept. of Plant Sciences,
submitted by Monsanto Co., Washington, DC; CDL:096631-A)
00108151 Monsanto Co. (1976) Residue, Uptake and Metabolism Studies: Round-
up. (Compilation; unpublished study received Dec 22, 1977 un-
der 524-EX-43; CDL:096684-A)
00108153 Monsanto Agricultural Products Co. (1975) Residues: Glyphosate on
Soybeans & Cotton. (Compilation; unpublished study received
Jun 21, 1977 under 7F1971; CDL:096191-A)
00108159 Monsanto Co. (1977) Residue and Metabolism Studies: Roundup.
(Compilation; unpublished study received Oct 25, 1977 under
524-308; CDL:096398-A)
00108168 Monsanto Co. (1977) Residue Studies and Methods of Analysis for
the Use of Glyphosate as a Sugarcane Ripener. (Compilation;
unpublished study received Aug 30, 1978 under 524-330; CDL:
097402-C)
00108171 EG & G", Bionomics (1975) Chronic Toxicity of Glyphosate to the Fat-
head Minnow (Pimephales promelas, Rafinesque). (Unpublished
study received Dec 27, 1978 under 524-308; submitted by Monsanto
Co., Washington, DC; CDL:097759-B)
00108172 McAllister, W.; Forbis, A. (1978) Acute Toxicity of Technical Gly-
phosate (AB-78-201) to Daphnia magna. (Unpublished study re-
ceived Dec 27, 1978 under 524-308; prepared by Analytical Bio-
Chemistry Laboratories, Inc., submitted by Monsanto Co., Wash-
ington, DC; CDL:097759-C)
00108173 Monsanto Co. (1978) Residue Studies for Use of Roundup Herbicide in
Aquatic Situations. (Compilation; unpublished study received
Dec 27, 1978 under 524-308; CDL:097760-A; 097761; 097762)
00108174 Monsanto Co. (1975) Efficacy of Roundup on Corn and Other Grain.
(Compilation; unpublished study received Dec 3, 1975 under
5F1536; CDL:097859-A)
00108175 Monsanto Co. (1979) Residue Studies—Bananas; Olives: Roundup.
(Compilation; unpublished study received Jun 20, 1979 under
524-308; CDL:098332-A)
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197
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Glyphosate Standard
MRID CITATION
00108176 Monsanto Co. (1975) Residue Studies^and Methods of Analysis for
Pre-emergent Use of Glyphosate in Cotton. (Compilation; un-
published study received May 20, 1976 under 6F1798; CDL:
098511-A)
00108186 Monsanto Co. (1976) Residue Studies and Methods of Analysis for
Use of Glyphosate in Pome Fruit Orchards. (Compilation; unpub-
lished study received Sep 7, 1976 under 524-308; CDL:228995-B)
00108192 Brightwell, B.; Malik, J. (1978) Solubility, Volatility, Adsorption
and Partition Coefficients, Leaching and Aquatic Metabolism of
MON 0573 and MON 0101: Report No. MSL-0207. Final rept. (Un-
published study received Jun 12, 1978 under 524-308; submitted
by Monsanto Co., Washington, DC; CDL:234108-A)
00108200 Grapenthien, N.; Jenkins, D.; (1973) Report to ...: Milk and Tissue
Residue Study with ... CP 67573 in the Cow: IBT No. 632-03894.
(Unpublished study received Jun 21, 1978 under 524-308; pre-
pared by Industrial Bio-Test Laboratories, Inc., submitted by
Monsanto Co., Washington, DC; CDL:234152-A)
00108203 Cowell, J.; Kramer, R.; Lottman, C.; et al. (1978) Residues in
Crops following Spot Treatments with Roundup Herbicide: Report
No. MSL-0282. Final rept. (Unpublished study received Jul 11,
1978 under 524-308; submitted by Monsanto Co., Washington, DC;
CDL:234319-B)
00108204 Fink, R.; Beavers, J.; Brown, R. (1978) Final Report: Acute Oral
LD50~Bobwhite Quail: Technical Glyphosate: Project No. 139-
140. (Unpublished study received Jul 14, 1978 under 524-308;
prepared by Wildlife International, Ltd. and Washington College,
submitted by Monsanto Co., Washington, DC; CDL:234395-A)
00108205 McAllister, W.; Forbis, A. (1978) Acute Toxicity of Technical
Glyphosate to Bluegill Sunfish (Lepomis macrochirus): Static
Acute Bioassay Report. (Unpublished study received Jul 14, 1978
under 524-308; prepared by Analytical Bio Chemistry Laborato-
ries, Inc., submitted by Monsanto Co., Washington, DC; CDL:
234395-B)
00108207 Fink, R.; Beavers, J. (1978) Final Report: One-generation Reproduc-
tion study—Bobwhite Quail: Glyphosate Technical: Project No.
139-141. (Unpublished study received Nov 13, 1978 under
524-308; prepared by Wildlife International, Ltd., submitted by
Monsanto Co., Washington, DC; CDL:235924-B)
1 98
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Glyphosate Standard
MRID CITATION
00108231 Conkin, R.; Serdy, F,; Street, R. (1979) A Short Residue Method
for Glyphosate, Active Ingredient in Roundup Herbicide: MSL-
0838. (Unpublished study received Jul 30, 1979 under 524-308;
submitted by Monsanto Co., Washington, DC; CDL:238888-A)
00109271 Monsanto Co. (19??) Crop Residues and Tolerances. (Unpublished
study received Apr 9, 1982 under KS 82/1 for Monsanto; CDL:
247348-B)
00111945 Monsanto Co. (1976) Residue and Plant Metabolism Studies. (Compi-
lation; unpublished study received Dec 8, 1976 under 524-308;
CDL:095633-A)
00111949 Danhaus, R.; Kramer, R. (1978) Glyphosate Residues in Stone Fruit
following Postemergent Directed Treatments with Roundup Herbi-
cide: Report No. MSL-0454. Final rept. (Unpublished study re-
ceived Nov 20, 1978 under 524-EX-47; prepared in cooperation
with Analytical Development Corp., submitted by Monsanto Co.,
Washington, DC; CDL:097636-A)
00111953 Fink, R.; Beavers, J. (1978) Final Report: One-generation Reproduc-
tion Study—Mallard Duck: Glyphosate Technical: Project No.
139-143. (Unpublished study received Nov 13, 1978 under
524-308; prepared by Wildlife International Ltd., submitted by
Monsanto Co., Washington, DC; CDL:235924-A)
00122715 Steinmetz, J.; Cowell, J. (1982) Glyphosate Residues in Wheat Grain
following Ropewick Wiper Treatment with Roundup Herbicide:
MSL-2569. (Unpublished study received Dec 17, 1982 under 524-
308; submitted by Monsanto Co., Washington, DC; CDL-.071296-A)
00124760 Forbis, A.; Boudreau, P.; Cranor, W. (1982) Dynamic 96-hour Acute
Toxicity of Roundup (AB-82-33) to Bluegill Sunfish (Lepomis
macrochirus): Dynamic Acute Bioassay Report #28746. (Unpub-
lished study received Dec 27, 1982 under 524-308; prepared by
Analytical Bio-Chemistry Laboratories, Inc., submitted by
Monsanto Co., Washington, DC; CDL:249159-A)
00124762 Forbis, A.; Boudreau, P.; Schofield, M. (1982) Dynamic 48-hour
Acute Toxicity of Roundup (AB-82-035) to Gammarus pseudolim-
naeus: Dynamic Acute Bioassay Report #28747. (Unpublished
study received Dec 27, 1982 under 524-308; prepared by Analyti-
cal Bio-Chemistry Laboratories, Inc., submitted by Monsanto
Co., Washington, DC; CDL:249159-C)
-17- 199
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Glyphosate Standard
MRID CITATION
00124763 McAllister, W.; McKee, M.; Schofield, M.; et alI. (1982) Chronic
Toxicity of Glyphosate (AB-82-036) to Daphnia magna under Flow-
through Test Conditions: Chronic Toxicity Final Report ABC
#28742. (Unpublished study received Dec 27, 1982 under 524-308;
prepared by Analytical Bio-Chemistry Laboratories, Inc., sub-
mitted by Monsanto Co., Washington, DC; CDL:249160-A)
00130406 Knezevich, A.; Hogan, G. (1983) A Chronic Feeding Study of Glypho-
sate (Roundup Technical) in Mice: Project No. 77-2061: BDN-77-
420. Final rept. (Unpublished study received Aug 17, 1983 un-
der 524-308; prepared by Bio/dynamics, Inc., submitted by Mon-
santo Co., Washington, DC; CDL:251007-A; 251008; 251009; 251010;
251011; 251012; 251013; 251014)
00132681 Li, A.; Kier, L.; Folk, R. (1983) CHO/HGPRT Gene Mutation Assay
with Glyphosate: EHL Study No. ML-83-155. Final rept. (Un-
published study received Nov 15, 1983 under 524-308; submitted
by Monsanto Co., Washington, DC; CDL:251737-B)
00132683 Li, A.; Kier, L.; Folk, R. (1983) In vivo Bone Marrow Cytogenetics
Study of Glyphosate in Sprague-Dawley Rats: Study No. 830083.
(Unpublished study received Nov 15, 1983 under 524-308; submit-
ted by Monsanto Co., Washington, DC; CDL:251737-D)
00132685 Ridley,- W., Dietrich, M.; Folk, R.; et al. (1983) A Study of the
Plasma and Bone Marrow Levels of Glyphosate following Intraperi-
toneal Administration in the Rat: Study No. 830109. (Unpublish-
ed study received Nov 15, 1983 under 524-308; submitted by Mon-
santo Co., Washington, DC; CDL-.251737-F)
00132686 Williams, G.; Tong, C.; Dirks, R.; et al. (1983) The Hepatocyte
Primary Culture/DNA Repair Assay on Compound JJN-1020 Using Rat
Hepatocytes in Culture: NDI/In vitro Facility Experimental
No. 083183A; Sponsor Order No. AH-83-181. (Unpublished study
received Nov 15, 1983 under 524-308; prepared by Naylor Dana
Institute for Disease Prevention, submitted by Monsanto Co.,
Washington, DC; CDL:251737-G)
GS0178-003 Suba, L. (1976) Metabolism of CP67573 in Representative Vegetables
and Rotation Crops: Final Report No. 406. Unpublished study
prepared by Monsanto Agricultural Research Dept. 57 p.
GS0178-004 Brightwell, B. (1978) Bioaccumlation and Metabolism of Glyphosate
in Channel Catfish (Ictalurus punctatus: Final Report No.
MSL-0381. Unpublished study prepared by Monsanto Agricultural
Research Dept. 34 p.
-18-
200
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Glyphosate Standard
MR ID CITATION
GS0178-014 Lauer, R.; Cowell, J.; Briggs, L.; "et al. (1974) Roundup and
Metabolite Residue Method Development for Animal Tissues and
Products: Appendix C. Unpublished study prepared by
Monsanto. 20 p.
GS0178-017 Monsanto Co. (1976) Analytical Residue Method for N-nitroso-N-
phosphonomethyl Glycine in Water: Method D. Unpublished
method. 7 p.
GS0178-018 Monsanto Co. (1978) Analytical Residue Method for N-nitrosoglyphosate
in Water: Method 3. Unpublished Method. 20 p.
GS0178-019 Storherr, R. (1980) Letter sent to E. Zager dated Sept. 19,
1980: Glyphosate HPLC Method trial on tomatoes and cottonseed.
3 p.
GS0178-020 Storherr, R. (1981) Letter sent to M. Nelson dated Jan 19, 1981:
Method trial on PP #OF2329, glyphosate in or on peanuts, by
an HPLC procedure. 3 p.
GS0178-022 Zee, K. (1975) Memorandum to J. Cummings dated Nov 1, 1975: PP
#5F1536. Method tryout for glyphosate on soybeans. 2 p.
GS0178-023 Zee, K. (1977) Memorandum to J. Cummings dated Feb 9, 1977: PP
#6F1733 and 6F1758. Method tryout for glyphosate in beef
liver. 2 p.
GS0178-025 Folmar, L.; Sanders, H.; Julin, A. (1979) Toxicity of the
herbicide glyphosate and several of its formulations to fish
and aquatic invertebrates. Arch. Environm. Contam. Toxicol.
8:269-278.
GS0178-028 Monsanto Co. (1976) Information to Support Establishment of a
Food Additive Tolerance for Glyphosate in Palm Oil: Special
Report No. 424. Vol 1 of 1, Sections A-J. Unpublished
study. 41 p.
201
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IV. FORMS APPENDICIES
EPA Form 8580-1 FIFRA §3(c)(2)(B) Summary Sheet
EPA Form 8580-6 Certification of Attempt to Enter Into an Agreement
With Other Registrants for Development of Data
EPA Form 8580- Product Specific Data Report (End-Use Products)
EPA Form 8580- Formulator's Exemption Statement
202
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OMB Approvtl No. 20O&O463
FIFHA SECTION 3(C)(2)(8) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANTS NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposed by th« FIFRA section 3(CI(2H8) notice contained in ths referj
Guidance Document. I *m responding hi the following manner
I. .1 will submit dan in a timely manner to at iffy the fallowing requirements. If the ten procedures I will UK deviate from ior are not
tpecified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Grouo. OECO
Chemicals Testing Programma, I enclose the protocols that I will use:
O 2. I have anttrtd into an agreement with one or more other registrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
2. I inclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Can" wi
respect to the following data requirements:
C 4. I rtquest ttiat you amend my registration by deleting the following uses (this option if not available to applicants lor new products):
D 5. I request voluntary cancellation of the registration of th« product. (Th« option « not available to applicants for new products.)
REGISTRANTS AUTHORIZED REPRESENTATIve
SIGNATURE
ETA Fomi 8680-1
DATE
203
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OMB Appro** No. 2OO&O468.
CERTIFICATION OF ATTEMFT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
(To qurtfr. certify ALL *»" **»" FOR DEVELOPMENT OF DATA
1. 1 am duly authorized to represent the following firm(t) who «r« subject to the require-
ments of • Notice under FIFRA Section 3(c)(2)(6) contained in a Guidance Document
to submit data concerning the active ingredient:
NAME OF FIRM
*•
/
ACTIVE INGRCOIENT
Ef A COMPANY NUMBER
1
!
(Th« firm or group of firms is referred to below as "my firm".) i
2. My firm it willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to ente
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following requiret
items or data:
3. My firm has offered in writing to enter into such an agreement. Copies of thr offerj arc attached. Thai offer was irrevocable and included in 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 dete(s):
NAME Of FIRM
DATE OF OFFER
However, none of those firm(s) accepted my offer.
4. My firm requests that EPA not suspend the registratkxi(s) of my firm's product (si. if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. .1 understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its registration^) under FIFRA Section 3(cl(2)(8r. (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
rrpEO NAME
EM Farm OStOt (10-C2)
SIGNATURE
DATE
204
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Registration No.
PRODUCT SPECIFIC DATA REPORT
Guidance Docunent for_
- , - Date
Registration
Guideline No.
§158.20
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3 .
63-4
63-5
63-6
63-7
63-8
63-9
63-10
.' 63-11
63-12
Name of Test
Identity of
Ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
cH
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID#
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
-
205
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Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
81r3
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/ reducing
reaction
Planmablllty
Explodabllity
Storage stability
Viscosity
Mlscibllity
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral LD-50,
rat
Acute dermal
LD-50
Acute Inhalation,
LC-50 rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
V
Citing MRID#
Submit-
ting
Data
(At-
tached)
(For EPA Dse Only)
Accession Nunbers
Assigned
,
206
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PORMULATOR'S EXEMPTION STATEMENT
(40 CFR 152.85)
EPA File Symbol/Reg. No. Product Name
Applicant's Name and Address
As an authorized representative of the applicant for registration of the
product identified above, I hereby certify that:
(1) This product contains the active ingredient(s):
(2) Each active ingredient listed in paragraph (1) is present solely
as the result of the incorporation into the product (during formulation or
packaging) of another product which contains that active ingredient, which
is registered under FIFRA sec. 3, and which is purchased by us from another
producer.
(3) Indicate by circling (A) or (B) below which paragraph applies:
(A) An accurate Confidential Statement of Formula (EPA Form 8570-4) for
the above identified product is attached to this statement. That formula
statement indicates, by company name, registration number and product
name, the source of the active ingredient(s) listed in paragraph (1).
OR
(B) The Confidential Statement of Formula dated on file with
the EPA is complete, current and accurate and contains the information
reguired on the current CSF Form No. 8570-4. The registered source(s)
of the active ingredient(s) listed in paragraph (1) is/are listed below:
Active ingredient Source: Product name and Reg. No.
Signature
nate Title
EPA Form (April 1985) Or\7
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