Reregistration Eligibility Decision (RED): Glyphosate


         United States
         Environmental Protection
         Agency
Office of Prevention, Pesticides  EPA 738-R-93-OII 6
And Toxic Substances     September 1993
(7508W)
vxEPA  Reregistration
         Eligibility Decision (RED)

         Glyphosate

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460
<(£ | rftf"
FEB | 6 1994
OFFICE OF
PREVENTION, PESTICIDES AND
TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:

I am pleased to announce that the Environmental Protection
Agency (the "Agency") has completed its reregistration eligibility
decision on the pesticide active ingredient glyphosate.

Enclosed is a Rereqistration Eligibility Decision (RED)
for the pesticide active ingredients isopropylamine salt
of glyphosate and sodium salt of glyphosate, hereafter referred to
as glyphosate. The RED is the Agency's evaluation of the
glyphosate data base, its conclusions regarding human and
environmental risks associated with the current product uses, and
its decisions and conditions under which uses and products will be
eligible for rereregistration. Also enclosed is the EPA RED faets
and the Pesticide Rereqistration Handbook which provides
instructions to registrants on how to respond to any labeling and
data requirements specified in the RED and how to reregister
products .

The RED identifies outstanding product specific data
requirements for end-use products and manufacturing-use products.
These requirements are listed on the Requirements Status and
Registrant's Response Form, which, along with the Data Call-in
Response Form listing all of your company's products subject to the
RED, is included as an Attachment, Instructions for completing
both forms are contained in the RED package. All product specific
data must be submitted and found acceptable by the Agency before a
product can be reregistered.

Generic data requirements usually will have been fulfilled
prior to making a reregistration eligibility decision. However,
there may be some instances where additional generic data are
required. If generic data requirements need to be fulfilled, all
registrants must complete the appropriate Data Call-in Response
FQrm and Requirements Status and Registrant's Response Forffl- These
forms are in the appendices to the RED.
R*cyci«
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The RED identifies any specific labeling requirements such as
restricted use classification, groundwater hazard statements,
endangered species precautions, etc., necessary for reregistration
based on a review of the generic data for the active ingredient.
In addition, in order to be reregistered, all product labeling must
be in compliance with format and content labeling as described in
40 CFR §156.10 and all labeling changes imposed by Pesticide
Regulation (PR) Notices, and any label changes imposed by this RED.

The Pesticide Reregistration Handbook contains detailed
instructions for compliance with the RED and must be followed
carefully. There are several key points to remember in preparing
your response to the RED:

Within 90 Davs of Your Receipt of this Letter

1. For each product which is subject to this RED, you must
complete, sign and submit the data call-in (DC!) response
forms attached to the RED [Appendix F, Attachments B and D,
has forms for product specific data]. Follow the instructions
in Attachments B and D for completing those forms and submit
the forms to the appropriate address specified in the Data
Call-ins. Note that the DCI forms are to be sent to the
Special Review and Reregistration Division (use the mailing
distribution code RJSD-SRRD-0178 for yousr generic response).

2* No time extensions will be granted for submitting the 90-day
responses. If the Agency does not receive a response for a
product, it may issue a Notice of Intent to Suspend (NOIS) for
that product.

3. Any requests for data waivers or time extensions to the 8-
month deadline must be submitted as part of your 90-day
response. Such requests will generally not be considered if
submitted later than the 90-day response.

Within 8 Months of the Date of this Letter

lo For each product, you must submit a completed Application for
Reregistration (EPA Form 8570-1), five copies of the label and
labeling revised as specified by the RED and in accordance
with current requirements, two completed copies of the
Confidential Statement of Formula (CSF) (EPA Form 8570-4), a
completed Certification with Respect to Citation of Data (EPA
.Form 8570-31), and data or references to data (see item 2
'below).

2. You must submit or cite the required product specific data as
part of your commit-ment for reregistration. For most
products, you will probably be citing data which have already
been submitted to the Agency. In these cases, you must submit
a list of the studies and the corresponding EPA identifier
numbers (i.e.., ACCESSION or MRID numbers). Before citing
these studies, you must make sure that they meet the
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Agency's current acceptance criteria (Appendix F, Attachment
E) . Be sure to follow data formatting requirements in P.R.
Notice 86-5. Failure to adequately comply with the data
requirements specified in this RED may result in the Notice of
Intent to Suspend your product.

3. The labeling and CSF which you submit for each product must
comply vith P.R. Notice 91-2 (Appendix D). That Notice
requires that the amount of active ingredient declared in the
ingredient statement must be stated as the nominal
concentration rather than, the lower certified limit. You have
two options for submitting a CSF: (1) accept the
standard certified limits (see 40 CFR §158.175) or (2) provide
certified limits that are supported by the analysis of five
batches. If you choose the second option, you must submit or
cite the data for the five batches along with a certification
statement as described in 40 CFR §158.175(e).

4. Send your Application for Registration to the Registration
Division Product Manager who is assigned to the product, PM
#25 Robert Taylor. Use the correct address shown on page 6 of
the enclosed Product Reregistration Handbook (Appendix E).
Note that the mailing distribution code for your response is
RED-RD-PM25.

Questions on product specific data requirements and labeling
(for both End-use and Manufacturing-use products) should be
directed to the Special Review and Registration Division Planning
and Reregistration Review Manager for glyphosate, Frank Rubis at
(703) 308-8184. Questions on the generic data requirements should
be directed to Eric Feris, the Chemical Review Manager in the
Special Review and Reregistration Division at (703) 308-8048 (call
via the Virginia Relay:" 1-800-828-1140).

The Agency is prepared to meet with any registrants who have
questions about responding to the glyphosate RED. If you wish to
meet vith the Agency, you must contact Erie Feris within two weeks
of your receipt of the RED. The Agency intends to have one
combined meeting with interested registrants. If there are any
requests for such a meeting, the Agency will notify all registrants
.who requested a meeting of the date, location and time. Requests
for a meeting will not extend the 90-day or 8-month response
deadlines. , '

Sincerely yours,
Daniel Barolo, Director
Special Review and
Reregistration Division
Enclosures
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-93-011
September 1993
R.E.D. FACTS
Glyphosate
Pesticide All pesticides sold or distributed in the United States must be
Beregistration registered by EPA, based on scientific studies showing that they can be
used without posing unreasonable risks to people or the environment.
Because of advances in scientific knowledge, the law requires that
pesticides which were first registered years agO;be reregistered to ensure
that they meet today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks. EPA then reregisters pesticides that can be used without
posing unreasonable risks to human health or the environment.
When a pesticide is eligible for ^registration, EPA announces this
and explains why in a Reregistration Eligibility Decision (RED) document.
This fact sheet summarizes the information in the RED document for
glyphosate.
Use Profile
Glyphosate is a non-selective herbicide registered for use on many
food and non-food field crops as well as non-crop areas where total
vegetation control is desired. When applied at lower rates, glyphosate also
is a plant growth regulator.
Glyphosate is among the most widely used pesticides by volume. It
ranked eleventh among conventional pesticides used in the U.S. during
1990-91. In recent years, approximately 13 to 20 million acres \vere
treated with 18.7 million pounds of glyphosate annually. The largest use
sites include hay/pasture, soybeans and field corn.
Three salts of glyphosate are used as active ingredients in registered
pesticide products. Two of these active ingredients, plus technical grade
glyphosate, are contained in the 56 products that are subject to this RED.
The isopropylamine salt, an active ingredient in 53 registered
products, is used as a herbicide to control broadleaf weeds and grasses in
many food and non-food crops and a variety of other sites including
ornamentals, lawns and turf, residential areas, greenhouses, forest
plantings and industrial rights-of-way. It is formulated as a liquid, solid or
pellet/tablet, and is applied using ground or aerial equipment.
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The sodium salt of glyphosate, an active ingredient in two registered
pesticide products, is used as a plant growth regulator for peanuts and
sugarcane, to modify plant growth and hasten the ripening of fruit. It is
applied as a ground spray to peanut fields and as an aerial spray to
sugarcane. Preharvest intervals are established for both crops.
The monoammonium salt of glyphosate is an active ingredient hi an
additional seven herbicide/growth regulator products. This form of
glyphosate was initially registered after November 1984, so it is not subject
to reregistration or included hi this RED. However, in reassessing the
existing glyphosate tolerances (maximum residue limits hi or on food and
feed), EPA included those for the monoammonium salt.

Regulatory EPA issued a Registration Standard for glyphosate hi June 1986
History (NTIS PB87-103214). The Registration Standard required additional
phytotoxicity, environmental fate, toxicology, product chemistry and
residue chemistry studies. All of the data required have been submitted
and reviewed, or were waived.
Huniafi Health
Assessment
Toxicity
Glyphosate is of relatively low oral and dermal acute toxicity. It has
been placed in Toxicity Category III for these effects (Toxicity Category I
indicates the highest degree of acute toxicity, and Category IV the lowest).
The acute inhalation toxicity study was waived because glyphosate is non-
volatile and because adequate inhalation studies with end-use products exist
showing low toxicity.
A subchronic feeding study using rats showed blood and pancreatic
effects. A similar study with mice showed reduced body weight gams hi
both sexes at the highest dose levels. A dermal study with rabbits showed
slight reddening and swelling of the skin, decreased food consumption hi
males and decreased enzyme production, at the highest dose levels.
Several chronic toxicity/carcinogenicity studies using rats, mice and
beagle dogs resulted hi no effects based on the parameters examined, or
resulted hi findings that glyphosate was not carcinogenic in the study. In
June 1991, EPA classified glyphosate as a Group E oncogen-one that
shows evidence of non-carcinogenicity for humans-based on the lack of
convincing evidence of carcinogenicity in adequate studies.
In developmental toxicity studies using pregnant rats and rabbits,
glyphosate caused treatment-related effects in the high dose groups
including diarrhea, decreased body weight gain, nasal discharge and death.
One reproductive toxicity study using rats showed kidney effects in
the high dose male pups; another study showed digestive effects and
decreased body weight gain. Glyphosate does not cause mutations.
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In one metabolism study with rats, most of the glyphosate
administered (97.5 percent) was excreted in urine and feces as the parent
compound; less than one percent of the absorbed dose remained in tissues
and organs, primarily in bone tissue. Aminomethyl phosphonic acid
(AMPA) was the only metabolite excreted. A second study using rats
showed that very little glyphosate reaches bone marrow, that it is rapidly
eliminated from bone marrow, and that it is even more rapidly eliminated
from plasma.
Dietary Exposure
The nature of glyphosate residue in plants and animals is adequately
understood. Studies with a variety of plants indicate that uptake of
glyphosate or AMPA from soil is limited. The material which is taken up
is readily translocated throughout the plant and into its fruit. In animals,
most glyphosate is eliminated hi urine and feces. Enforcement methods are
available to detect residues of glyphosate and AMPA in or on plant
commodities, hi water and hi annual commodities.
85 tolerances have been established for residues of glyphosate and its
metabolite, AMPA, in or on a wide variety of crops and crop groups, as
well as in many processed foods, animal feed and animal tissues (please
see 40 CFR 180.364, 40 CFR 185.3500 and 40 CFR 186.3500). EPA has
reassessed the existing and proposed tolerances for glyphosate. Though
some adjustments will be needed, no major changes in existing tolerances
are required. EPA also has compared the U.S. tolerances with
international Codex maximum residue limits (MRLs), and is recommending
certain adjustments to achieve greater compatibility.
EPA conducted a dietary risk assessment for glyphosate based on a
worst-case risk scenario, that is, assuming that 100 percent of all possible
commodities/acreage were treated, and assuming that tolerance-level
residues remained in/on all treated commodities. The Agency concluded
that the chronic dietary risk posed by glyphosate food uses is minimal.
A reference dose (RfD), or estimate of daily exposure that would not
cause adverse effects throughout a lifetime, of 2 mg/kg/day has been
proposed for glyphosate, based on the developmental toxicity studies
described above.
Occupational and Residential Exposure
Occupational and residential exposure to glyphosate can be expected
based on its currently registered uses. However, due to glyphosate's low
acute toxicity and the absence of other toxicological concerns (especially
carcinogeniclty), occupational and residential exposure data are not
required for reregistration.
Some glyphosate end-use products are in Toxicity Categories I or II
for primary eye irritation or skin irritation. In California, glyphosate ranks
high among pesticides causing illness or injury to workers, who report
numerous incidents of eye and skin irritation from splashes during mixing
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and loading. EPA is not adding any personal protective equipment (PPE)
requirements at this time, but any existing PPE label requirements must be
retained.
The Worker Protection Standard (WPS) for Agricultural Pesticides
(please see 40 CFR 156 and 170) established an interim restricted entry
interval (REI) of 12 hours for glyphosate. The Agency has decided to
retain this REI as a prudent measure to mitigate risks to workers. During
the REI, workers may reenter areas treated with glyphosate only hi the
few, narrow exceptions allowed hi the WPS. The REI applies only to
glyphosate uses within the scope of the WPS, so homeowner and
commercial uses are not included.
Human Risk Assessment
EPA's worst case risk assessment of glyphosate's many registered
food uses concludes.that human dietary exposure and risk are minimal.
Existing and proposed tolerances have been reassessed, and no significant
changes are needed to protect the public.
Exposure to workers and other applicators generally is not expected
to pose undue risks, due to glyphosate's low acute toxicity. However,
splashes during mixing and loading of some products can cause injury,
primarily eye and skin irritation. EPA is continuing to recommend PPE,
including protective eye wear, for workers using end-use products that are
hi Toxicity Categories I or II for eye and skin irritation. To mitigate
potential risks associated with reentering treated agricultural areas, EPA is
retaining the 12 hour REI set by the WPS.
Environmental
Assessment
Environmental Fate
Glyphosate adsorbs strongly to soil and is not expected to move
vertically below the six inch soil layer; residues are expected to be
immobile in soil. Glyphosate is readily degraded by soil microbes to
AMPA, which is degraded to carbon dioxide. Glyphosate and AMPA are
not likely to move to ground water due to their strong adsorptive
characteristics. However, glyphosate does have the potential to
contaminate surface waters due to its aquatic use patterns and through
erosion, as it adsorbs to soil particles suspended in runoff. If glyphosate
reached surface water, it would not be broken down readily by water or
sunlight.
Ecological Effects
Glyphosate is no more than slightly toxic to birds and is practically
non-toxic to fish, aquatic invertebrates and honeybees. Due to the
presence of a toxic inert ingredient, some glyphosate end-use products must
be labeled, "Toxic to fish," if they may be applied directly to aquatic
environments. Product labeling does not preclude off-target movement of
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glyphosate by drift. EPA therefpre is requiring three additional terrestrial
plant studies to assess potential risks to nontarget plants.
EPA does not expect that most endangered terrestrial or aquatic
organisms will be affected by the registered uses of glyphosate. However,
many endangered plants as well as the Houston toad (due to its habitat)
may be at risk. EPA is deferring any use modifications or labeling
amendments until it has published the Endangered Species Protection Plan
and has given registrants guidance regarding endangered species
precautionary labeling.

Ecological Effects Risk Assessment
Based on current data, EPA has determined that the effects of
glyphosate on birds, mammals, fish and invertebrates are minimal. Under
certain use conditions, glyphosate may cause adverse effects to nontarget
aquatic plants. Additional data are needed to fully evaluate the effects of
glyphosate on nontarget terrestrial plants. Risk reduction measures will be
developed if needed, once the data from these studies are submitted and
evaluated.

Additional Data EPA is requiring three generic studies (Tier II Vegetative Vigor,
Required Droplet Size Spectrum, and Drift Field Evaluation) which are not part of
the target data base and do not affect the reregistration eligibility of
glyphosate. The Agency also is requiring product-specific data including
product chemistry and acute toxicity studies, as well as revised
Confidential Statements of Formula and revised labeling.
Product Labeling
Changes Required
All end-use glyphosate products must comply with EPA's current
pesticide product labeling requirements. In addition:
• Protection of Aquatic Organisms
Non-Aquatic Uses - End-use products that are not registered for
aquatic uses must bear the following label statement:
Do not apply directly to water, to areas -where surface water is
present or to intertidal areas below the mean high water mark. Do
not contaminate water when disposing of equipment washwaters and
rinsate.
Aquatic Uses - End-use products registered for aquatic uses must
bear the following label statement:
Do not contaminate water when disposing of equipment washwaters
and rinsate. Treatment of aquatic weeds can result in oxygen loss
from decomposition for dead plants. This loss can cause fish kills.
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• Worker Protection Standard (WPS) Requirements
Any product whose labeling permits use in the production of an
agricultural plant on any farm, forest, nursery or greenhouse must comply
with the labeling requirements of:
• PR Notice 93-7, "Labeling Revisions Required by the Worker
Protection Standard (WPS)," and
• PR Notice 93-11, "Supplemental Guidance for PR Notice 93-7."
Unless specifically directed hi the RED, all statements required by these
two PR Notices must appear on product labeling exactly as instructed hi
the Notices. Labels must be revised by April 21, 1994, for products
distributed or sold by the primary registrant or supplementally registered
distributors, and by October 23, 1995, for products distributed or sold by
anyone.
• Personal Protective Equipment (PPE)
No new PPE requirements must be added to glyphosate labels.
However, any existing PPE requirements on labels must be retained.
• Entry Restrictions
Products Not Primarily Intended for Home Use:
o Uses Within the Scope of the WPS - A 12-hour restricted entry
interval (REI) is required for all products with uses within the scope
of the WPS, except products intended primarily for home use. The
PPE for early entry should be that required for applicators of
glyphosate, except any applicator requirement for an apron ors
respirator is waived. This REI and PPE should be inserted into the
standardized statements required by PR Notice 93-7.
• Sole Active Ingredient End-Use Products - Labels must be
revised to adopt the entry restrictions set forth in this section.
Any conflicting entry restrictions on current labeling must be
removed.
• Multiple Active Ingredient Products - Registrants must
compare the entry restrictions set forth in this section to those
on then- current labeling and retain the more protective. A
specific time period in hours or days is considered more
protective than "until sprays have dried" or "dusts have
settled."
o Uses Not Within the Scope of the WPS - No new entry restrictions
must be added. However, any entry restrictions on current product
labeling with these uses must be retained.
Products Primarily Intended for Home Use:
° No new entry restrictions must be added. However, any entry
restrictions on current product labeling must be retained.
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Regulatory
Conclusion
The use of currently registered pesticide products containing the
isopropylamine and sodium salts of glyphosate in accordance with the
labeling specified in this RED will not pose unreasonable risks or adverse
effects to humans or the environment. Therefore, all uses of these
products are eligible for reregistration.
These glyphosate products will be reregistered once the required
product-specific data, revised Confidential Statements of Formula and
revised labeling are received and accepted by EPA.
Products which contain active ingredients in addition to glyphosate
will not be reregistered until all their other active ingredients also are
eligible for reregistration.
For More
Information
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for glyphosate during a 60-day time period, as
announced in & Notice of Availability published in the Federal Register.
To obtain a copy of the RED document or to submit written comments,
please contact the Pesticide Docket, Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of Pesticide
Programs (OPP), US EPA, Washington, DC 20460, telephone 703-
305-5805.
Following the comment period, the glyphosate RED document will
be available from the National Technical Information Service (NTIS), 5285
Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
For more information about EPA's pesticide reregistration program,
the glyphosate RED, or reregistration of individual products containing
glyphosate, please contact the Special Review and Reregistration Division
(7508W), OPP; US EPA, Washington, DC 20460, telephone 703-
308-8000.
For information about the health effects of pesticides, or for
assistance in recognizing and managing pesticide poisoning symptoms,
please contact the National Pesticides Telecommunications Network
(NPTN). Call toll-free 1-800-858-7378, between 8:00 am and 6:00 pm
Central Time, Monday through Friday.
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REREGISTRATION ELIGIBILITY DECISION DOCUMENT

GLYPHOSATE

LIST A
CASE 0178
US Environmental Protection Agency
Office of Pesticide Programs
Special Review and Reregsitration Division
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GLYPBOSATE RED
September 1993
GLYPHOSATE REREGISTRATION ELIGIBILITY TEAM

Office of Pesticide Programs:

Special Review and Rereoistration Division
Eric Fer/s . . . Reregistration Branch

Health Effects Division
Jane Smith Chemical Coordination Branch
Krystyna Locke ,,.......,....,... Toxicology Branch I
Jeff Evans .»..„... Occupational and Residential Exposure Branch
Randolph Perfetti . . Chemistry Branch - Reregistration Support

Biological and Economic Analysis Division
James G. Saulmon . . . . Biological Analysis Branch
Eric Maurer , Economic Analysis Branch

Environmental Fate and Effects Division
Candace Brassard ,,.,.. , . Ecological Effects Branch
Kevin Poff ....,«,,.,, . . Environmental Fate and Groundwater Branch
BernicQ Slutsky ,,,.,,.,..,,,..., Science Analysis and Coordination Staff

Registration Division
Mark Perry . . . Registration Support Branch
Karen P, Hicks ,..,.. Fungicide-Herbicide Branch

Policy and Special Projects Staff
Jean Frane Food Safety & Regulation Tracking Section

Office of General Counsel:

Pesticides and Toxic Substances Division
Debra Burton Pesticides Branch

Office of Compliance Monitoring:

Policy and Grants Division
Beverly Updike FIFRA Policy & Analysis Branch
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CLYfHOSATS RED
Sfptember 1993
TABLE OF CONTENTS

GLOSSARY OF TERMS AND ABBREVIATIONS vi

EXECUTIVE SUMMARY yiii

I INTRODUCTION 1

li. CASE OVERVIEW • • 2

A. Chemical Overview 2

B. Use Profile 2

C. Estimated Usage of Pesticide 7

D. Data Requirements ,....,...,..................> 9

E. Regulatory History >...,., 9

HI. SCIENCE ASSESSMENT 9

A. Product Chemistry 9

B. Human Health Assessment 10

1. Toxicology Assessment 10

a. Acute Toxicity 10

b. Subchronic Toxicity 11

c. Chronic Toxicity 12

d. Carcinogenicity 13

e. Developmental Toxicity 15

f. Reproductive Toxicity 16
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GLYPHOSATB RED
September 1993
g. Mutagenicity . 17

h. Metabolism 17

i. Neurotoxicity . . 18

j. Other Toxicological Endpoints 19

k. Reference Dose . . . 19

2. Exposure Assessment . 20

a. Dietary Exposure '. 20

b. Occupational and Residential 21

3. Risk Assessment -.'..*. 23

a, Dietary .,,,,,,,,,.,........,........,.,,. 23

b. Occupational and Residential ...........*.......'. 24

c. Dietary Exposure References , , 24

0. Environmental Assessment ........ .'.... 30

1. Environmental Fate . » . 30

a. Environmental Fate and Transport 30

b. Environmental Fate and Groundwater Assessment .... 37

2. Ecological Effects -.' 37

a. Ecological Hazard • • • • 37

b. Ecological Effects Risk Assessment 53

IV. RISK MANAGEMENT AND REREGISTRATION DECISION ...... 57

A. Determination of Eligibility 57
iii
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GLVPHOSATB RED
September 1993
1. Eligibility Decision . • 57

2. Eligible and Ineligible Uses • 58

B. Regulatory Position 58

1. Tolerance Re-assessment . . 58

2. Labeling Rationale , 70

3. Endangered Species Statement ., 70

V. ACTIONS REQUIRED BY REGISTRANTS 70

A. Manufacturing-Use Products 70

1. Additional Generic Data Requirements 70

2. Labeling Requirements for Manufacturing-Use Products ..... 71

B. End-Use Products ,,...,,,, 71

1. Additional Product-Specific Data Requirements 71

2. Labeling Requirements for End-Use Products 72

a. Nonaquatic 72

b. Aquatic 72

C. Existing Stocks 74

VI. APPENDICES 74

Appendix A - Use Patterns Subject to Reregistration

Appendix B -
Appendix C -
Table of the Generic Data Requirements and Studies Used to Make
the Reregistration Decision

Citations Considered to be Part of the Data Base Supporting the
Reregistration of Glyphosate
IV
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GLYPHOSATE RED
September 1993
Appendix D -

Appendix E -

Appendix F -
List of Available Related Documents
Pesticide Reregistration Handbook

Generic and Product-Specific Data Call-In
« Attachment 1
• Attachment 2
Chemical Status Sheet
Generic Data Call-In and Product Specific Data Call-In
Response Forms with instructions
« Attachment 3 - Generic Data Call-In and Product Specific Data Call-In
Requirements Status and Registrants' Response Forms with
Instructions
• Attachment 4 - EPA Grouping of End Use Products for Meeting Acute
Toxicology Data Requirements.
EPA Acceptance Criteria
List of all Registrant(s) sent this Data Call-In
Cost Share/Data Compensation Forms
• Attachment 5
• Attachment 6
• Attachment 7
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September 1993
a.i.

CAS

CFR

CSF

EEC

EPA

FJFRA
FR

HOT
LD
60
LDte

LEL

MATC
GLOSSARY OF TERMS AND ABBREVIATIONS

Active Ingredient

Chemical Abstracts Service

Code of Federal Regulations

Confidential Statement of Formula

Estimated Environmental Concentration. The estimated pesticide
concentration in an environment, such as a terrestrial ecosystem.

End-Use Product

U.S. Environmental Protection Agency

Federal Insecticide, Fungicide, and Rodenticide Act

Federal Food, Drug, and Cosmetic Act

federal Register

Highest Dose Tested

Median Lethal Concentration. A statistically derived concentration of a
substance that can be expected to cause death in 50% of test animals.
It is usually expressed as the weight of substance per weight or volume
of water or feed, e.g., mg/l or ppm.

Median Lethal Dose. A statistically derived single dose that can be
expected to cause death in 50% of the test animals when administered
by the route indicated (oral or dermal). It is expressed as a weight of
substance per unit weight of animal, e.g., mg/kg.

Lethal Dose-low. Lowest Dose at which lethality occurs

Lowest Effect Level

Maximum Allowable Toxicant Concentration: A range at which the
pesticide causes no effect (NOEL) and the lowest dose at which an effect
was observed (LOEL).
VI
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GLYPHOSATE RED
September 1993
MP Manufacturing-Use Product

MPI Maximum Permissible Intake

MRID Master Record Identification (number). EPA's system of recording and
tracking studies submitted.

N/A Not Applicable

NPDES National Pollutant Discharge Elimination System

NOEL No Observed Effect Level

OPP Office of Pesticide Programs

PADI Provisional Acceptable Daily Intake

ppm Parts Per Million

RE! Restricted Entry Interval

RfD Reference Dose

RS Registration Standard

TD Toxic Dose. The dose at which a substance produces a toxic effect.

TC Toxic Concentration. The dose at which a substance produces a toxic
effect.

TMRC Theoretical Maximum Residue Contribution.

WPS Worker Protection Standard
VII
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GLYPHOSATE RED
September 1993
EXECUTIVE SUMMARY

This document addresses the reregistration eligibility of the pesticide
glyphosate. There are 63 glyphosate-containing products registered for use in the
United States. The isopropylamine salt of glyphosate, the active ingredient in 53 of
these registrations, is used as a herbicide to control a number of broadleaf weeds and
grasses. The principal food use sites include corn, wheat, sorghum, citrus and stone
fruits, potatoes and onions, asparagus, coffee, peanuts, and pineapples. There are
also a number of non-food use sites including ornamental, turf, forestry, and industrial
rights-of-way. Two registrations contain the sodium salt of glyphosate and are used in
sugarcane fields. In addition there are seven herbicide/plant regulation products
containing the monoammonium salt of glyphosate which were registered subsequent
to the development of List A and are not a subject of this RED. Except where
explicitly noted otherwise/the term "glyphosate," when used in this document, refers
to either the technical acid or the isoproplyamine and sodium salts of glyphosate.
However, the monoammonium salt is included in the tolerance expression. Available
data have been sufficient to allow re-assessment of existing tolerances, which
includes the monoemmonium salt of glyphosate.

In June 1986, the Agency issued the document "Registration Standard for
Pesx.cide Products Containing Glyphosate as the Active Ingredient" (ISITIS #PB87-
103214). The Registration Standard required scientific studies in the areas of
phytotoxicity, environmental fate, toxicology, product chemistry, and residue
chemistry. With the exception of a few waived studies, all of the data required have
been submitted. After completing its review for reregistration, the Agency now
concludes that the data base on glyphosate is substantially complete.

Based on the results of its reregistration review, EPA has concluded that all
registered uses of glyphosate are eligible for reregistration. The Agency has classified
glyphosate as a Group E carcinogen (signifies evidence of non-carcinogenicity in
humans). A Reference Dose of 2 mg/kg/day has been recommended. This proposal is
based on a maternal NOEL of 175 mg/kg/day from a rabbit developmental toxicity
study and an uncertainty factor of 100. The dietary risk assessment is based on a
worst-case scenario, assuming treatment of 100% of acreage and highest legal
residue values which likely result in an overestimation of exposure and risk. Even with
these values, however, dietary exposure is expected to be minimal. There are 85
tolerances established for various crops and crop groups as well as Federal Food,
Drug, and Cosmetic Act §409 tolerances for processed food and animal feed and
animal tolerances. A re-assessment of tolerances is included in this document and
there are no major changes in the previously-established tolerances. Studies show
that glyphosate is no more than slightly toxic to birds and is practically non-toxic to
fish and honeybees. However, a toxic inert in glyphosate end use products
VIII
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GLYPBOSATB RED
September 1993
necessitates the labelling of some products "toxic to fish" since some glyphosate
products are applied directly to aquatic environments.

The Agency does have concerns regarding the potential hazard to endangered
plant species and the Houston toad. However, the Agency is not requiring any
modification of use or label changes in this document. A Federal Register Notice on
the Endangered Species Protection Plan and subsequent guidance to registrants will
impose appropriate exposure mitigation measures for areas where endangered plant
species and the Houston toad may be encountered. In addition, there have been a
number of reported incidents of spray drift damage to non-target crops. Spray drift
studies are required as is a Tier III Vegetative Vigor study. These studies are not part
of the target data base for reregistration of glyphosate.

Before reregistering each product, the Agency is requiring that product specific
data in the areas of product chemistry and acute toxicology, revised Confidential
Statements of Formula, and revised labeling be submitted within eight (8) months of
the issuance of this document. In an effort to reduce the time, resources, and number
of animals needed to fulfill the acute toxicology data requirements for glyphosate
containing end use products, the Agency has "batched" products considered to be
similar with respect to acute toxicity testing requirements. After reviewing these data
and '<$}& rsv&ed labels, the Agency will determine whether to re-register a product
base
-------
-------
GLYPHOSATE RED
September 1993
I. INTRODUCTION

In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregistration of products with active ingredients
registered prior to November 1, 1984. The amended Act provides a schedule for
the reregistration process to be completed in nine years. There are five phases to
the reregistration process. The first four phases of the process focus on
identification of data requirements to support the reregistration of an active
ingredient and the generation and submission of data to fulfill the requirements.
The fifth phase is a review by the U.S. Environmental Protection Agency (referred
to as ;itha Agency") of all data submitted to support reregistration.

FIFRA Section 4{g)(2)(A) states that in Phase 5 "the Administrator shall
determine whether pesticides containing such active ingredient are eligible for
registration" before calling in data on products and either re-registering products
or taking "other appropriate regulatory action." Thus, reregistration 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 determina the need for
additional data on health and environmental effects; and to determine whether the
pesticide meets the "no unreasonable adverse effects" criterion of FIFRA.

This document presents the Agency's decision regarding the reregistration
eligibility of the registered uses of the isopropylamine salt and the sodium salt
formulations of glyphosate. Except where explicitly noted otherwise, the term
"glyphosate," when used in this document, refers to either the technical acid or the
isoproplyamine and sodium salts of glyphosate but does not cover the
monoammonium salt products since the compound was not included in the Federal
Register publication of List A. The document consists of six sections. Section I
is the introduction. Section II describes glyphosate, its uses, data requirements
and regulatory history. Section III discusses the human health and environmental
assessment based on the data available to the Agency. Section IV presents the
reregistration decision for glyphosate. Section V discusses the reregistration
requirements for glyphosate. Finally, Section VI is the Appendices which support
this Reregistration Eligibility Document. Additional details concerning the Agency's
review of applicable data are available on request.1
EPA's reviews of data on the set of registered uses considered for EPA's analysis may be
obtained from the OPP Public Docket, Field Operations Division (H7506C), Office of Pesticide
Programs, EPA, Washington, DC 20460.
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GLYffiOSATE RED
September 1993
II. CASE OVERVIEW

A. Chemical Overview

The following active ingredient(s) are covered by this Reregistration
Eligibility Document:
Common Name:

Chemical Name:
glyphosate

N-phosphonomethyl glycine
CAS Registry Number: 38641-94-0

OPP Chemical Codes: 103601 (isopropylamine salt)
103603 (sodium salt)
Empirical Formula:

Trade Names:

Basic Manufacturer:
C3H8N05P

Roundup, Rodeo, Shackle

Monsanto Company
800 N. Lindbergh Blvd.
St. Louis, MO 63167
B. Use Profile
The following is information on the current registered uses with an
overview of use sites and application methods. A detailed table of the uses
of glyphosate is given in Appendix A.
Chemical:

Type of Chemical:

Mechanism of Action:
glyphosate, isopropylamine salt (103601)

herbicide

not known at this time, but it appears to inhibit
the aromatic amino acid biosynthesis pathway
and may inhibit or repress chlorismate mutase
and/or prephenate hydratase.
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GLYPHOSATE RED
September 1993
Use groups and sites:

AQUATIC FOOD CROP:
agricultural drainage systems, irrigation systems, lakes/ponds/reservoirs
(with human or wildlife use), streams/rivers/channeled water.

AQUATIC NON-FOOD INDUSTRIAL:
aquatic areas/water, drainage systems, sewage systems.

AQUATIC NON-FOOD OUTDOOR:
aquatic areas/water ,

FORESTRY:
conifer release, forest plantings (reforestation programs), forest trees (all or
unspecified).

GREENHOUSE FOOD CROP:
greenhouses-muse,

INDOOR NON-FOOD:
greenhouse-empty,

OUTDOOR RESIDENTIAL:
household/domestic dwellings outdoor premises.

TERRESTIAL FEED CROP:
alfalfa, barley, beans, buckwheat, corn, grass forage/fodder/hay, lentils,
millet (prpso), nongrass forage/fodder/straw/hay, oats, pastures, rye,
sorghum, wheat.

TERRESTRIAL FOOD CROP:
acerola (West Indies Cherry), apricot, artichoke (Jerusalem), asparagus,
atemoya, avocado, banana, beech nut, beets, blackberry, blueberry,
boysenberry, brazil nut, breadfruit (breadnut), broccoli, brussels sprouts,
butternut, cabbage, cabbage (Chinese), carambola (jalea), carrot (including
tops), cashew, cauliflower, celery, chard (swiss), cherimoya, cherry,
chestnut, chicory, cocoa, coffee, collards, cranberry, cress (water),
cucumber, currant, date, dewberry, eggfruit tree (canistel), eggplant,
elderberry, endive (escarole), fig, filbert (hazelnut), garlic, gooseberry,
gourds, groundcherry (strawberry tomato/tomatillo), guava, hickory nut,
horseradish, huckleberry, jaboticaba, jackfruit, kale, kitembilla (ceylon
-------
GLYPHOSATB RED
September 1993
gooseberry), kiwi fruit, kohlrabi, leek, lettuce, litchi nut, loganberry, longan,
loquat, macadamia nut (bushnut), mamey (mammee apple), mango,
marmaladebox (genipapo), mayhaw (hawthorn), melons, melons
(cantaloupe), melons (honeydew), melons (mango), melons (musk), melons
(water), melons winter (casaba/crenshaw/honeydew/persian), mustard,
nectarine, okra, olive, onion, papaya, parsley, passion fruit, peach, pear,
pecan, pepper, persimmon, pistachio, plantain, plum, pomegranate, prune,
pumpkin, quince, radish, raspberry (black, red), rhubarb, rutabaga, sapodilla,
sapota (white), soursop, spinach, squash (summer), squash (winter), sugar
apple (custard apple), sweet potato, tamarind, taro, tea, walnut
^English/black), yam,

TERRESTRIAL FOOD + FEED CROP:
agricultural fallow/idleland, almond, apple, barley, beans, beets
(unspecified), buckwheat, calamondin, citron (citrus), citrus hybrids other
thantangelo, corn (unspecified), corn (field), cotton (unspecified), grapefruit,
grapes, kumquat, lemon, lentils, lime, millet proso (broomcorn), mustard,
oats, orange, parsnip, peanuts (unspecified), peas (unspecified), pineapple,
potato (white/irish), pummelo (shaddock), rape, rice, rice (wild), rye,
sorghum, soybeans (unspecified), sugar beet, sugarcane, tangelo,
tangerines, tomato, triticale, turnip, wheat.

TERRESTRIAL + GREENHOUSE NON-FOOD CROP:
ornamental and/or shade trees, ornamental woody shrubs and vines.

TERRESTRIAL NON-FOOD CROP:
agriculturalfallow/idleland,agriculturalrights-of-way/fencerows/hedgerows,
agricultural uncultivated areas, airports/landing fields, Christmas tree
plantations, golf course turf, industrial areas (outdoor), nonagricultural
outdoor buildings/structures, nonagricultural rights-of-
way/fencerows/hedgerows, nonagricultural uncultivated areas/soils,
ornamental and/or shade trees, ornamental lawns and turf, ornamental
woody shubs and vines, paths/patios, paved areas (private roads/sidewalks),
recreational areas, urban areas.

TERRESTRIAL NON-FOOD + OUTDOOR RESIDENTIAL:
ornamental and/or shade trees, ornamental herbaceous plants, ornamental
lawns and turf, ornamental woody shubs and vines.
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GLYPHOSATE RED
September 1993
Pests: many broadleaf and grass weeds

Formulation types registered:

SINGLE ACTIVE INGREDIENT:
Form Not Identified/Liquid
53.50 % glyphosate, isopropylamine salt
41.00 % glyphosate, isopropylamine salt
Form Not Identified/Solid
76.00 % glyphosate, isopropylamine salt
Liquid-Ready to Use
19.70 % glyphosate, isopropylamine salt
18.30 % glyphosate, isopropylamine salt
15.80 % glyphosate, isopropylamine salt
1.00 % glyphosate, isopropylamine salt
0.96 % giyphosate, isopropylamine salt
0.50 % glyphosate, isopropylamine salt
Manufacturing Use
94.00 % giyphosate, isopropylamine salt
Pelteted/Tableted
83.50 % giyphosate, Isopropylamine salt
60.00 % glyphosate, isopropylamine salt
Pressurized Liquid
0.96 % glyphosate, isopropylamine salt
0.75 % glyphosate, isopropylamine salt
Soluble Concentrate/Liquid
62.00 % glyphosate, isopropylamine salt
53.80 % glyphosate, isopropylamine salt
41.50 % glyphosate, isopropylamine salt
41.00 % glyphosate, isopropylamine saTF
28.60 % glyphosate, isopropylamine salt
25.10 % glyphosate, isopropylamine salt
18.00 % glyphosate, isopropylamine salt
10.00 % glyphosate, isopropylamine salt
8.20 % glyphosate, isopropylamine salt
7.00 % glyphosate, isopropylamine salt
5.00 % glyphosate, isopropylamine salt
Soluble Concentrate/Solid
93.96 % glyphosate, isopropylamine salt
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GLYPHOSATE RED
September 1993
MULTIPLE ACTIVE INGREDIENT:
Liquid-Ready to Use
12.40 % glyphosate, isopropylamine salt + 1 other A.I.
7.70 % glyphosate, isopropylamine salt + 1 other A.I.
0.50 % glyphosate, isopropylamine salt + 1 o.ther A.I.
0.25 % glyphosate, isopropylamine salt + 1 other A.I.
Soluble Concentrate/Liquid
16.50 % glyphosate, isopropylamine salt + 1 other A.I.
14.80 % glyphosate, isopropylamine salt + 1 other A.I.
13.30 % glyphosate, isopropylamine salt + 1 other A.I.
12.90 % giyphosate, isopropylamine salt + 1 other A.I.

Methods and rates of application (Given in maximum active (acid equivalent
(ae)) rates, except as otherwise noted):

Broadcast or spray; for example as needed:

Form Not Identified/Liquid - rates were not specified in
Appendix A dated 8/12/93;

Form Not Identified/Solid - rates were not specified in
Appendix A dated 8/12/93;

Liquid-Ready to Use - applied at rate of 3.08 Ib ae/A;

Pelleted/Tableted - applied as a spot treatment, for example from a hand
held sprayer;

Pressurized Liquid - applied as a spot treatment, for example from an aerosol
can;

Soluble Concentrate/Liquid - applied at rate of 7.5 Ib ae/A;

Soluble Concentrate/Solid - applied at rates of 0.09 gal ae/A;
Chemical: glyphosate, sodium salt (103603)

Type of Chemical: plant regulator

Mechanism of Action: modifies plant growth; hastens fruit ripening
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GLYPHOSATE RED
September 1993
Use Groups and Sites:

TERRESTRIAL FOOD + FEED CROP:
peanuts (unspecified); sugarcane

Formulation Types Registered:

SINGLE ACTIVE INGREDIENT:
soluble concentrate/solid
75.0% glyphosate, sodium salt

Methods and Rates of Application:

soluble concentrate/solid - applied as ground spray at peanut bloom stage
at 0.0375 Ib a.i./A in 10 gal water;

soluble concentrate/solid - applied as aerial spray at sugarcane ratoon stage
at 0.525 Ib a.i./A in 5 gal water.

Use Limitations:
sugarcane - 21 days preharvest interval; peanuts - 84 days preharvest
interval. Do not apply this product through any type of irrigation system.

C. Estimated Usage of Pesticide

This section summarizes the best estimates available for the pesticide
uses of glyphosate. These estimates are derived from a variety of published
and proprietary sources available to the Agency. The data, reported on an
aggregate and site (crop) basis, reflect annual fluctuations in use patterns
as well as the variability in using data from various information sources.

The table below summarizes glyphosate useage by site.
: •••:•;• ":-,,;•, i Gfyphoiite tJsage r> '. " ",; -V . .,..-•
Site
non-ag areas
almonds
apples
Multiple Acres
Treated (xlOOO)
unknown
350-390
75-275
Pounds AI
(xlOOO)
3000-7000
500-550
65-200
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GLYPBOSATE RED
September 1993
barley
cherries
com, field
cotton
hay/pasture
dry edible beans/peas
grapefruit
grapes
lemons
other ag sites
oranges
peaches
peanuts
peats
pecans
plums/prunes
rice
sorghum
soybeans
spring wheat
sugarcane
potatoes
sunflowers
sweet com
tomatoes
green beans/peas
walnuts
winter wheat
TOTAL
550-600
15-95
1,300-1,700
300-1,000
3,000-3,500
50
70-140
45-550
5-75
3,000-3,500
300-600
10-150
10-30
15-50
5-300
5-80
30-55
450-550
2,600-4,800
200-225
10-70
20-40
60-70
10-30
30-40
20-40
150-175
350-1,150
12,985-20,280
275-325
20-125
1,100-1,200
225-375
1,500-1,700
20
183-375
25-265
10-70
1^000-1,500
650-1,300
10-110
5-10
15-65
5-150
WO
25-30
__ 11
100-150
2,200-2,400
50-60
5-35
25-30
25-40
5-15
15-30
5-20
100-125
250-450
11,398-18,745
8
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GLYPHOSATE RED
September 1993
In a typical year between 1989 and 1991, approximately 13-20
million acre treatments were made with 18.7 million pounds active
ingredient. Hay/pasture (20%), soybeans (20%), field corn (9%), and other
agricultural areas |20%) comprise 71% of the total acreage treated with
glyphosate. Non-agricultural areas (33%), soybeans (15%), hay/pasture
(11 %), and corn (8%) comprise 67% of the total pounds of active ingredient
applied. I

D. Data Requirements _.. i. ..._ .

Data required in the June 1986 Registration Standard for glyphosate
include studies on product chemistry, ecological effects, environmental fate,
toxicology, and residue chemistry. These data were required to support the
uses listed in the Registration Standard. Appendix B includes all data
requirements identified by the Agency for currently registered uses needed
to support reregistration.

E. Regulatory History

Glyphosate is registered in the United States for use as a herbicide.
The June 1986 Registration Standard evaluated the studies currently on file
at the Agency and required submission of further data. This Reregistration
Eligibility Document reflects an assessment of all data which were submitted
in response to the Registration Standard.

ill. SCIENCE ASSESSMENT

A. Product Chemistry
'ff
OH-C-CH2-NH-CH2-P03H2
MOLECULAR STRUCTURE OF GLYPHOSATE
Empirical Formula: C3H8N05P
Molecular Weight: 169.07
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GLYPBOSATE RED
September 1993
CAS Registry No.: 38641-94-0
Shaughnessy No.: 103601 (isopropylamine salt, IPA)
103603 (sodium salt)

The glyphosate (N-phosphonomethyl glycine) salts are nonselective
herbicides and plant growth regulators. The technical isopropylamine salt
(IPA) is a white crystalline solid with a melting point of 200°C and a bulk
density of 1.74 Ib/ft3. It is 1% soluble in water at 25°C and insoluble in
ethanol, acetone, or benzene. The technical sodium salt is a white
crystalline solid which decomposes at 140°C with a bulk density of 30
!b/ft3,

B. Human Health Assessment

1. Toxicology Assessment

The lexicological data base on glyphosate is adequate and will
support reregistration eligibility.

a. Acute Toxicity

The table below summarizes the toxicity results and
categories for technical grade glyphosate. The acute inhalation
study was waived by the Agency since glyphosate technical is
a nonvolatile solid and adequate inhalation studies were
conducted on the end-use product formulations.
Acute Toxicity
Test
Acute Oral (rat) (i)
Acute Dermal (rabbit)(j)
Acute Inhalation (i)
Result
> 4320 mg/kg
> 2g/kg
Not Required
Category
m
m
N/A
1 - MRTO 00067039
The following table is derived from MPs considered
toxicologically similar to glyphosate technical.
10
-------
GLYPHOSATS RED
September 1993
-
Test
Eye Irritation (i)
Dermal Irritation (z)
Skin Seasitization (3)
Acute ToxicSty
Result
mild irritation, clears in 7
days
slight irritation
negative
-
Category
ffl
IV
N/A
1 - MRID 41400603
2 - MRID 41400604
3 - MRIDs 00137137, 00137138, 00137139, 00137140
Other studies submitted to the Agency give similar
results. They are acceptable for reregistration (MRIDs
41400601, and 41400602)

b. Subchronic Toxicity

In a 90-day feeding study Sprague-Dawley rats were fed
diets containing 0, 1000, 5000 or 20000 ppm of glyphosate
for three months. These doses were equivalent to 0, 63, 317
and 1267 mg/kg/day, respectively (males) and 0, 84, 404 and
-•-• 1623 mg/kg/day, respectively (females). The following
findings were regarded as possibly treatment-related: (1)
increased serum phosphorus and potassium in all treated
groups, males and females; (2) increased serum glucose in the
mid-dose and high-dose males; (3) increased blood urea
nitrogen (BUN) and serum alkaline phosphatase in the high-
dose males; and (4) occurrence of pancreatic lesions in the
high-dose males (pancreas was not examined in the low-dose
and mid-dose groups). Based on these findings, the systemic
NOEL is < 1000 ppm (not determined definitively) for both
sexes. (MRIDs 40559401, and 00093879)

In a second 90-day feeding study CD-1 mice v*ere fed
diets containing 0, 250, 500 or 2500 mg/kg/day of glyphosate
for three months. Body weight gains of the high-dose males
and females were about 24% and 18% lower, respectively,
than those of the controls. Body weight gains of the low-dose
and mid-dose groups were comparable to those of the controls.
11
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GLYPHOSATE RED
September 1993
Based on the reduced body weight gains in both sexes, the
NOEL for systemic toxicity is 500 mg/kg and the LOEL is 2500
mg/kg. (MRID 00036803)

In a 21-day dermal study glyphosate was applied to the
skin of New Zealand white rabbits using 10 rabbits/sex/dose (5
with intact and 5 with abraded skin). The levels of glyphosate
tested were 1Q, 1000 or 5000 mg/kg/day. The rabbits were
exposed for three consecutive weeks, 6 hours/day, 5
days/week. Treatment-related effects observed only in the
high dose groups included: (1) very slight erythema and
edema in intact and abraded skin of both sexes; (2) decreased
food consumption in males; and (3) decreased serum lactic
dehydrogenase in both sexes. Based on these effects, the
NOEL for males and females is 1000 mg/kg/day and the LOEL
is 5000 mg/kg/day. {MRID 00098460)

The required 90-day feeding study in dogs is satisfied by
the one-year dog feeding study. (MRID 00153374)

Chronic Toxicity

A chronic feeding/carcinogenicity study was conducted
using male and female Sprague-Dawley rats which were fed
diets containing 0, 30, 100 or 300 ppm of glyphosate for 26
months. These levels were equivalent to 0, 3, 10 and 31 mg
of glyphosate/kg/day, respectively, for the males and 0, 3, 11
and 34 mg of glyphosate/kg/day, respectively, for the females.
There were no effects based on any of the parameters
examined (toxic signs, mortality, body weights, food
consumption, hematology, clinical chemistry, urinalysis, organ
weights and organ/tissue pathology). Therefore, the NOEL for
systemic toxicity is ^300 ppm (HOT; males: 31 mg/kg/day
and females: 34 mg/kg/day). (MRID 00093879)

A second chronic feeding/carcinogenicity study was
conducted using male and female Sprague-Dawley rats which
were fed diets containing 0, 2000, 8000 or 20000 ppm of
glyphosate for 2 years. These levels were equivalent to 0, 89,
362 or 940 mg/kg/day, respectively, for the males and 0, 113,
457 or 1183 mg/kg/day, respectively, for the females.
Treatment-related effects observed only in the high-dose group
12
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GLYPHOSATE RED
September 1993
included: (1) In the females: decreased body weight gains; and
(2) In the males: increased incidence of cataracts and lens
abnormalities, decreased urinary pH, increased absolute liver
weight and increased liver weight/brain weight ratio (relative
liver weight). No significant systemic effects were observed
in the low-dose and mid-dose male and female groups.
Therefore, the NOEL for systemic toxicity is 8000 ppm (males:
362 mg/kg/day and females: 457 mg/kg/day) and the LOEL is
20000 ppm (HOT; males: 940 mg/kg/day and females: 1183
mg/kg/day), (MRID 41643801)

A chronic study was conducted using male and female
beagle dogs which were given glyphosate in gelatin capsules
containing 0, 20, 100 or 500 mg/kg/day for one year. There
were no effects based on all parameters examined, in all
groups. Therefore, the NOEL for systemic toxicity is s* 500
mg/kg/day, for both sexes. (MRID 00153374)

d. Carcinogenicity

A chronic feeding/carcinogenicity study was conducted
using Sprague-Dawley rats which were fed diets containing
glyphosate (males: 0, 3, 10 or 31 mg/kg/day and females: 0,
i 3, 11 or 34 mg/kg/day) for 26 months. The following findings
were observed in the high-dose groups when compared with
: •: the concurrent controls: (1) increased incidence of thyroid C-
cell carcinomas in females; and (2) increased incidence of
interstitial cell (Leydig cell) testicular tumors. However, the
Agency concluded that these neoplasms were not treatment-
related and glyphosate was not considered to be carcinogenic
in this study because the incidence of thyroid carcinomas was
not statistically significant and the incidence of testicular
tumors was within the historical incidence. The Agency also
concluded that this study was not conducted at high enough
dose levels for an adequate negative carcinogenicity. (MRID
00093879)

A chronic feeding/carcinogenicity study was conducted
using Sprague-Dawley rats fed diets containing glyphosate
(males: 0, 89, 362 or 940 mg/kg/day and females: 0, 113,
457 or 1183 mg/kg/day) for 2 years. The study showed a
slightly increased incidence of (1) pancreatic islet cells
13
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GLYPHOSATE RED
September 1993
adenomas in the low-dose and high-dose males; (2)
hepatocellular (liver) adenomas in the low-dose and high-dose
males; and (3) thyroid C-cells adenomas in the mid-dose and
high-dose males and females. The Agency concluded that
these adenomas were not treatment-related and glyphosate
was not considered to be carcinogenic in this study. With
respect to pancreatic islet cells adenomas, there was no
statistically significant positive dose-related trend in their
occurrence; there was no progression to carcinomas; and the
incidence of pancreatic hyperplasia (non-neoplastic lesion) was
not dose-related. With respect to hepatocellular adenomas, the
increased incidence of these neoplasms was not statistically
significant in comparison with the controls; the incidence was
within the historical control range; there was no progression to
carcinomas; and the incidence of hyperplasia was not
compound-related. With respect to thyroid C-cell adenomas,
there was no statistically significant dose-related trend in their
occurrence; the increased incidence was not statistically
significant; there was no progression to carcinomas; and there
was no significant dose-related increase in severity or
incidence of hyperplasia in either sex. (MRID 41643801)

A carcinogenicity study in mice was conducted with CD-
1 mice fed diets containing 0, 150, 750 or 4500 mg/kg/day of
glyphosate for 18 months, No effects were observed in the
low-dose and mid-dose groups. The following findings were
observed in the high-dose group: (1) decreased body weight
gain in males and females; (2) increased incidence of
hepatocellular hypertrophy, hepatocellular necrosis and
interstitial nephritis in males; (3) increased incidence of
proximal tubule epithelial basophilia and hypertrophy in
females; and (4) slightly increased incidence of renal tubular
adenomas, a rare tumor, in males. Based on these effects, the
systemic NOEL and LOEL were 750 mg/kg/day and 4500
mg/kg/day, respectively. The Agency concluded that the
occurrence of these adenomas was spontaneous rather than
compound-induced because the incidence of renal tubular
adenomas in males was not statistically significant when
compared with the concurrent controls. An independent group
of pathologists and biometricians also conducted extensive
evaluations of these adenomas and reached the same
14
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GLYPHOSATB RED
September 1993
conclusion. Therefore, glyphosate was not considered to be
carcinogenic in this study. (MRIDs 00130406, and 00150564)

On June 26, 1991, the Agency classified glyphosate in
Group E (evidence of non-carcinogenicity for humans), based
on a lack of convincing evidence of carcinogenicity in adequate
studies with two animal species, rat and mouse.

e. Developmental Toxicity

A developmental toxicity study was conducted with
pregnant Charles River COBS CD rats which were administered
0, 300, 1000 or 3500 mg/kg/day of glyphosate by gavage
during gestation days 6 through 19. Treatment-related effects
observed only in the high-dose dams included: (1) diarrhea; (2)
decreased mean body weight gain; (3) breathing rattles; (4)
inactivity; (5) red matter around the nose and mouth, and on
forelimbs and dorsal head; (6) decreases in total
implantations/dam and inviable fetuses/dam; and (7) deaths
(6/25 or 24% of the group). Treatment-related developmental
effects observed only in the high-dose group included: (1)
increased number of litters and fetuses with unossified
sternebrae; and (2) decreased mean fetal body weights.
Therefore, the NOEL and LOEL for maternal toxicity are 1000
mg/kg/day and 3500 mg/kg/day, respectively. The NOEL and
LOEL for developmental toxicity are 1000 mg/kg/day and 3500
mg/kg/day, respectively. (MRID 00046362)

In a second study, pregnant Dutch Belted rabbits were
administered 0, 75, 175 or 350 mg/kg/day of glyphosate by
gavage during gestation days 6 through 27. Treatment-related
findings were observed only in the high-dose group and
included: (1) diarrhea; (2) nasal discharge; and (3) death
(10/16 or 62.5% of does died by gestation day 21).
DeveSopmental toxicity was not observed at any dose tested.
Therefore, the NOEL and LOEL for maternal toxicity are 175
mg/kg/day and 350 mg/kg/day, respectively. The NOEL for
developmental toxicity is 5: 175 mg/kg/day. Due to high
maternal mortality at the 350 mg/kg/day dose level, too few
litters (only 6) were available to assess adequately
developmental toxicity at that level. (MRID 00046363)
15
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GLYPUOSATE RED
September 1993
f. Reproductive Toxicity

A reproduction study was conducted with male and
female Sprague-Dawley rats which were administered 0, 3,10
or 30 mg/kg/day of glyphosate continuously in the diet for
three successive generations. The only effect observed was
an increased incidence of focal tubular dilation of the kidney
(both unilateral and bilateral combined) in the high-dose male
F3b pups. Therefore, the NOEL for systemic and reproductive
toxicity is ^ 30 mg/kg/day (HOT). The NOEL and LOEL for
developmental toxicity are 10 mg/kg/day and 30 mg/kg/day,
respectively. (MRID 00105995}

Another reproduction study was conducted with
Sprague-Dawley rats which were administered 0, 100, 500 or
1500 mg/kg/day of glyphosate continuously in the diet for two
successive generations. Treatment-related effects observed
only in the high-dose group included: (1) soft stools, very
frequent, in the F0 and F, males and females; (2) decreased
food consumption and body weight gain of the F0 and F, males
and females during the growth (premating) period; and (3)
decreased body weight gain of the F1a, F2B and F2b male and
female pups during the second and third weeks of lactation.
Focal tubular dilation of the kidneys, observed'in the previous
study (00105995), was not observed at any dose level in this
study. Based on the above findings, the systemic NOEL and
LOEL are 10000 ppm (500 mg/kg/day) and 30000 ppm (1500
mg/kg/day), respectively. The reproductive NOEL is 30000
ppm (1500 mg/kg/day; HOT); and the developmental NOEL and
LOEL are 10000 ppm (500 mg/kg/day) and 30000 ppm (1500
mg/kg/day), respectively. (MRID 41621501)

Since the focal tubular dilation of the kidneys was not
observed at the 1500 mg/kg/day level (HOT) in the 2-
generation rat reproduction study but was observed at the 30
mg/kg/day level (HOT) in the 3-generation rat reproduction
study (00105995), the Agency concluded that the latter was
a spurious rather than glyphosate-related effect.
16
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GLYPHOSATE RED
September 1993
g. Mutagenicity

A Gene mutation assay in an Ames Test was conducted
using glyphosate, both with and without metabolic activation.
The strains of Salmonella typhlmurium used were TA98,
TA100, TA1535 and TA1537. No increases in reverse
mutations were observed at any concentration. (MRID
00078620}

A gene mutation assay in mammalian cells was
conducted using glyphosate in the Chinese hamster ovary
(CHO) cells/hypoxanthine - guanine -phosphoribosyl transferase
(HGPRT) assay, with and without metabolic activation. No
mutagenic response was observed either with or without
metabolic activation up to the limit of cytotoxicity {10 mg/MI).
(MRID 00132681)

A Structural Chromosomal Aberration Assay was
conducted using a single dose of glyphosate administered
intraperitoneally (i.p.) to male and female Sprague-Dawley rats.
The dose used was 1 g/kg of body weight and the bone
marrow cells were examined for clastogenic (chromosome-
damaging) effect. No significant clastogenic effects were
observed. {MRID 00132683}

in a fourth study, glyphosate was tested in two assays:
the rec~assay using B. subtilis H17 (rec+) and M45 (rec*); and
the reverse mutation assays using £. coif WP2 her and
Salmonella typhimurium strains TA98, TA100, TA1535,
TA1537 and TA1538, with and without metabolic activation.
No increases in mutations were observed in either study.
{MRID 00078619)

h. Metabolism

Two metabolism studies with rats are available. In the
first study, single or repeated doses of radiolabeled 14C-
gfyphosate were administered orally to male and female
Sprague-Dawley rats. Following a single oral dose of 14C-
glyphosate, 30 to 36% of the dose was absorbed and less
than 0.27% of the dose was eliminated as C02. Ninety-seven
point five percent of the administered dose was excreted in the
17
-------
GLYPHOSATE RED
September 1993
urine and feces as the parent compound, glyphosate. Amino
methyl phosphonic acid (AMPA) was the only metabolite found
in urine (0.2-0.3% of the administered dose) and feces (0.2-
0.4% of the administered dose). Less than 1.0% of the
absorbed dose remained in tissues and organs, primarily in
bone tissue. Repeated dosing at 10 mg/kg did not significantly
change the metabolism, distribution or excretion of glyphosate.
(MRIDs 40767101, and 40767102)

In a second study, male and female Sprague-Dawley rats
received single intraperitoneal injections of radiolabeled 14C-
glyphosate. The dose level of glyphosate used for male and
female rats was 1150 mg/kg. Blood samples were collected
0.25, 0.50, 1, 2, 4, 6 and 10 hours after injection. Femoral
bone marrow samples were collected from one third of the
male and female rats sacrificed at 0.5, 4, or 10 hours after
injection. Thirty minutes after injection of glyphosate, the
concentration of radioactivity in the bone marrow of male and
female rats was equivalent to 0.0044% and 0.0072%,
respectively, of the administered dose. Assuming first order
kinetics, the decrease in radioactivity in bone marrow occurred
with a half-life of 7.6 and 4.2 hours for males and females,
respectively, Similarly, the half-lives of the radioactivity in
plasma were approximately 1 hour for both sexes. These
findings indicate that very little glyphosate reaches bone
marrow, that it is rapidly eliminated from bone marrow and that
it is even more rapidly eliminated from plasma. (MRID
00132685)

Neurotoxicity

The acute and 90-day neurotoxicity screening battery in
the rat (guidelines 81-8-SS, 82-7) is not being required since
there was no evidence of neurotoxicity seen in any of the
existing studies at very high doses and this chemical lacks a
leaving group; therefore, it would not seem likely to inhibit
esterases (the presumptive neurotoxic mechanism of concern
for all organophosphates).
18
-------
GLYPHOSATE RED
September 1993
Other Toxicoiogical Endpoints

A dermal penetration study (guideline 85-2} with
technical grade glyphosate is not being required because there
are no toxicological endpoints to indicate this study is
necessary.

Domestic Animal Safety Studies (86-1) are not being
required for the use patterns of glyphosate (a plant growth
regulator and herbicide).

Technical grade glyphosate certains N-nitrosoglyphosate
(NNG) as a contaminant. Carcinogenicity testing of nitroso
contaminants is normally required only in those cases in which
the level of nitroso compounds exceeds 1.0 ppm. Analyses
showed that greater than 92% of the individual technical
glyphosate samples contained less than 1.0 ppm NNG. The
Agency concluded that the NNG content of glyphosate was not
lexicologically significant.

Reference Dose

On August 27, 1992, the Agency's Office of Pesticide
Programs Reference Dose (RfD) Peer Review Committee
recommended that the RfD for glyphosate be established at 2
mg/kg/day. This value was based on the maternal NOEL of
175 mg/kg/day from the rabbit developmental toxicity study
(00046363) and an uncertainty factor (UF) of 100. This RfD
has not yet been confirmed by the Agency RfD Work Group.

In September of 1986, the Joint Food and Agricultural
Organization of the United Nations (FAO)/World Health
Organization (WHO) on Pesticides Residues [JMPR] proposed
an Allowable Daily Intake (ADD of 0.3 mg/kg body weight for
glyphosate perse. The ADI was based on a 26-month feeding
study in the rat yielding a NOEL of > 31 mg/kg body weight
per day and and uncertainty factor of 100. The Agency places
more importance on the developmental rabbit study since no
effect was observed in the 26-month study whereas maternal
mortality was observed in the developmental rabbit study in
19
-------
GLYPHOSATE RED
September 1993
the high dose group. JMPR acknowledged that there is no
effect at the highest dose tested in the 26-month rat study.
i

Exposure Assessment

a. .Dietary Exposure

The qualitative nature of the residue in plants is
adequately understood. Studies with a variety of plants
including corn, cotton, soybeans, and wheat indicate that the
uptake of glyphosate or its metabolite, aminomethyl
phosphonic acid (AMPA), from soil is limited. The material
which is taken up is readily translocated. Foliarly applied
glyphosate is readily absorbed and translocated throughout the
trees or vines to the fruit of apples, coffee, dwarf citrus
(calamondin), pears and grapes. Metabolism via N-methylation
yields N-methylated glycines and phosphonic acids. For the
most part, the ratio of glyphosate to AMPA is 9 to 1 but can
approach 1 to 1 in a few cases (e.g., soybeans and carrots).
Much of the residue data for crops reflects a detectable residue
of parent (0.05 • 0,15 ppm) along with residues below the
level of detection (<0.05 ppm) of AMPA. The terminal residue
to be regulated in plants is glyphosate per se.

The qualitative nature of the residue in animals is
adequately understood. Studies with lactating goats and laying
hens fed a mixture of glyphosate and AMPA indicate that the
primary route of elimination was by excretion (urine and feces).
These results are consistent with metabolism studies in rats,
rabbits, and cows. The terminal residues in eggs, milk, and
animal tissues are glyphosate and its metabolite AMPA; there
was no evidence of further metabolism. The terminal residue
to be regulated in livestock is glyphosate per se.

An adequate enforcement method is available for
analysis of residues of glyphosate and its metabolite AMPA in
or on plant commodities and in water. This method utilizes
GLC (Method I of PAM Vol. II; limit of detection is 0.05 ppm).
For enforcement of tolerances in animal commodities, an HPLC
method with fluorescence detection is available; the reported
limits of detection are 0.01 ppm for glyphosate and 0.012 ppm
for AMPA.
20
-------
GLYPHOSATE RED
September 1993
The available storage stability data indicate that residues
of glyphosate and its metabolite AMPA are stable under frozen
-storey -conditions -{--20 °C): Jn .or 4x0 nJam UDJnmjpdijLes for a
period of 1 year, in animal commodities for 2 years, and in
water for 1 year. No additional storage stability data are
needed.

All data requirements for magnitude of the residue in
plants have been evaluated and deemed adequate. Additional
potato processing data are being generated. All data
requirements for magnitude of the residue in plants as a result
of irrigation with glyphosate-treated water have also been
submitted and are adequate to support registered use and
applicable tolerances. No additional data are required for
magnitude of the residue in animals, potable water, and fish.
A list of residue chemistry study references is provided on
page 24.
b. Occupational and Residential

Occupational and residential exposure can be expected
based on the currently registered uses of products containing
glyphosate. However, due to the low toxicity (acute category
III) of glyphosate and the lack of other toxicological concerns
(i.e carcinogenicity) occupational and residential exposure data
are not required. Glyphosate is a non-selective herbicide
applied to terrestrial food and non-food crops, turf, greenhouse
crops, and non-crop areas where total vegetation control is
desired. Glyphosate, when applied at lower rates, is also a
plant growth regulator.

Although glyphosate meets the Agency's exposure
criteria for post-application/reentry and/or
mixer/loader/applicator exposure monitoring data, glyphosate
does not meet the Agency's toxicity criteria for these data
requirements. Acute oral and dermal toxicity data for the
technical material are in Toxicity Category III and IV. In
addition, glyphosate is poorly absorbed dermally. The acute
inhalation toxicity study for the technical material was waived
because glyphosate is non-volatile and because there were
adequate inhalation studies with end-use products showing low
21
-------
CLYFHOSATB RED
September 1993
toxicity. Therefore, occupational and residential exposure data
are not required to support the reregistration of glyphosate.
(For these same reasons, these data were not required in the
1986 Registration Standard.)

The following information is product-specific related, but
is presented here for informational purposes. Some glyphosate
end-use products are in Toxicity Category I and II based on
primary eye irritation or dermal irritation. In California, where
physicians are required to report pesticide poisonings,
glyphosate was ranked third out of the 25 leading causes of
illnesses or injury due to pesticides used between 1980 and
1984. These mixer/loader/applicator reported incidents
consisted of eye and skin irritation. In reports issued by
California since then (1987 and 1988), glyphosate continued
to be a leading cause of illnesses or injuries (primarily eye and
skin irritation). In the 1986 Registration Standard, the Agency
recommended personal protective equipment, including
protective eyewear for mixer/loader/applicators using end-use
products that could cause eye or skin irritation. At that time,
it was determined that mixer/loaders were at risk of eye or skin
injury from splashes during mixing and loading. The Agency
did not require personal protective equipment for users of
"homeowner" products (containing up to 10% glyphosate)
because of the low concentration of glyphosate and because
the products are "ready-to-use", requiring no mixing;
therefore, the potential for eye or dermal exposure is
minimized.

The Agency, at this time, is not adding any additional
personal protective equipment requirements to the labels of
end-use products; however, any existing personal protective
equipment on those labels must be retained.

The Worker Protection Standard (WPS) for Agricultural
Pesticides -- 40 CFR Parts 156 and 170 -- established an
interim restricted entry interval (RED of 12 hours for glyphosate
because the acute toxicity categories of glyphosate for acute
dermal toxicity, skin irritation potential, and eye irritation
potential are Toxicity Category III or IV. The Agency has
determined that the 12-hour REI for all WPS sites should be
retained as a prudent measure to mitigate risk to workers
22
-------
GLYPHOSATE RED
September 1993
entering treated areas after application. Furthermore, given the
known irritation-effects concerns for glyphosate, the Agency
considers the additional protections offered by the
requirements in the WPS essential to its decision that a 12-
hour REI for.this chemical will offer sufficient risk mitigation to
workers. Therefore, during the REI the Agency will allow
workers to enter areas treated with .glyphosate during the REI
only in the few narrow exceptions allowed in the WPS.

The Agency has determined that, at this time, the entry
restrictions discussed in this section need not apply to uses of
glyphosate ouside the scope of the Worker Protection Standard
for Agricultural Chemicals, including out-of-scope commercial
uses and homeowner uses. The predicted frequency, duration,
and degree of exposure due to post-application as the result of
such uses should not warrant the risk mitigation measures
being required for persons engaged in the production of
agricultural plants for commercial or research purposes.
Risk Assessment
a. Dietary
The chronic dietary risk analysis used tolerance level
residues and assumed all acreage, of the crops considered,
was treated with glyphosate to estimate the Theoretical
Maximum Residue Contribution (TMRC) for the overall U.S.
population and 22 population subgroups. These exposures
(TMRCs) were then compared to the RfD for glyphosate to
estimate chronic dietary risk.

The calculated TMRC for the overall U.S. population
from food uses of glyphosate is 0.025 mg/kg bwt/day, which
represents 1.2% of the RfD. The subgroup most highly
exposed, non-nursing infants less than one year old, has a
TMRC of 0.058 mg/kg bwt/day, or 2.9% of the RfD. Over one
third of the dietary exposure and risk from glyphosate is due to
the proposed tolerances on wheat.

This analysis was meant to be a "worst case" scenario
of risk. The inclusion of recommended tolerances for
reregistration as wel! as tolerances recommended for
23
-------
GLYPHOSATB RED
September 1993
revocation; the use of the highest existing, pending, or
recommended residue value for each commodity; and the
assumptions of tolerance level residues and treatment of 100
percent of the crops for every commodity considered result in
an overestimation of exposure and risk values for glyphosate
(though there is some underestimation due to the lack of
consumption information for some of the commodities to which
glyphosate is expected to be applied). Nonetheless, given the
risk values arrived at by this analysis, EPA concludes that the
chronic dietary risk posed by this pesticide on these food uses
is minimal.

b. Occupational and Residential

As discussed above in the occupational exposure
assessment, exposure to humans from proper application of
glyphosate to terrestrial food and non-food crops as well as
greenhouses, turf, and non-crop areas can result in injury
(primarily eye and skin irritation) from splashes during mixing
and loading. The Agency continues to recommend protective
clothing (including protective eye wear) for
mixer/loader/applicators using end-use products that may be in
toxicity category I or II for primary eye and dermal irritation.

c. Dietary Exposure References

This table references the residue data used to support
the reregistration of glyphosate and includes the commodities
eligible for reregistration.
Guiddine/Commodity
References1
§171-4 (a): Plant Metabolism
00038771, 00039141, 00051983, 00065753,
00108097, 00108129, 00108133, 00108140,
00108151,00111945
§171-4 (b): Animal Metabolism
00094971, 00108098, 00108099, 00108100,
00108101, 00108116, 00108099, 00108200,
40541301-40541304
24
-------
GLYPHOSATE RED
September 1993
Guideline/Commodity
§171-4 (c) and (d): Residue Analytical Methods
§171-4 (e): Storage Stability
References'
00028853, 00036222, 00036223, 00036231,
00037688, 00038770, 00038979, 00044423,
00051982, 00053002, 00053005, 00060108,
00061559, 00063714, 00065751, 00065752,
00067425, 00076805, 00078823, 00078824,
00108133, 00108144, 00108149, 00108151,
00108175, 00108176, 00108186, 00108231,
00111945, 00111949, 00122715, 00159419,
00164729, 40502601, 40541304
00039142, 00040083, 00051980, 00053002,
00061553, 00061555, 00108129, 00108132,
40502605, 40532004, 41940701
§171-4 (k) (1): Magnitude of the Residue in Plants
Root and Tuber Vegetables Group
- Artichokes, Jerusalem
- Bests, garden
- Ciiicory
- Horseradish
- Parsnips
- Potatoes

- Radish
- Rutabagas
- Salsify
- Sugar beets

- Sweet potato
- Turnips

Leaves of Root and Tuber
Vegetables Group
- Beets, greens
- Chicory leaves
- Sugar beet tops
N/A
00108159
00108159
N/A
N/A
N/A
00108151, 41947001

00108159
N/A
N/A
00039381, 00108151

00108151
40835201
N/A
N/A
00039381, 00108151
25
-------
CLVPHOSATE RED
September 1993
Guideline/Commodity
f. % Jr-jT^ f ± &•£"*&)•. £•*»** I
tZ0w4&'f*t References'
- Turnip tops

Bulb Vegetables Croup
-Garlic
- Onions (green and dry bulb)

Leafy Vegetables (except Brassies)
Group
-Celery
- Lettuce (head and leaf)
- Spinach

Brsssica Leafy Vegetables Group
-Broccoli
- Cabbage
- Cauliflower
-Kale
- Mustard greens
Vegetables
(St'ccufcat/Driedy Group
- Beans (succulent and dried)
-Lentils
- Peas (succulent and dried)
-Soybeans
(processed commodities)

Foliage of Legume Vegetables
(Succulent/Dried) Group
- Bean vines and hay
- Lentil forage and hay
- Pea vines and straw
40835201
N/A
40783101
N/A
00108159
N/A
40802801, 40802801
00108159
N/A
N/A
40802801, 40802801
00108159
00108159
00108159
00015759, 00015760, 00015761, 00015762,
00015763, 00015764, 00015765, 00015766,
00015767, 00024503, 00033954, 00038908,
00040084, 00061555, 00108153, 00108203
00061555, 00108153, 00156793
00108159
00108159
26
-------
GLYPHOSATE RED
September 1993
Guideline/Commodity
References1
Soybean forage and hay
00015759, 00015760, 00015761, 00015762,
00015763, 00015764, 00015765, 00015766,
00015767, 00033954, 00038908, 00040084,
00061555, 00108153, 00108203 •
Fruiting Vegetables Group

Cucurbit Vegetables Group

Citrus Fruits Group
(processed commodities)

Pome Fruits Group

Stone Fruits Group
- Plums (fresh prunes)
00039142
40159401

00108129

00111949
00111949
Small Fruits and Berries Group
- Blackberries
- Blueberries
- Cranberries
- Grapes
. (processed commodities)
- Raspberries

Tree Nuts Group
- Almond hulls

Cereal G"»ns Group
- Barley
(processed commodities)
- Corn (field and fresh)

(processed commodities)
-Oats
(processed commodities)
00053002
00038770, 00108132
40785303
00111945
00111945
00038908, 00040087, 00044422, 00108203
N/A
00023336, 00023512, 00037687, 00038908,
00040085, 00048284, 00108203, 40502602
40502604, 41478101
00038908, 00040087, 00044422, 00108203
N/A
27
-------
GLYPffOSATE RED
September 1993
Guideline/Commodity
References'
V i a
-Rice
(processed commodities)
-Rye
(processed commodities)
- Sorghum

(processed commodities)
-Wheat

(processed commodities)
Forage. Fodder, and Straw of Cereal Grains Group
- Barley forage, hay, and straw
• Com forage and fodder

• Oat forage, hay, and straw
» Rice straw
• Rye forage and straw
• Sorgnuoi forage and fodder
forage and straw

Cr«as Forage. Fodder, and Hay
Group '
Non-grass Anj"1^ i<**ds (forage.
fodder, straw, and hay) Group
- Alfalfa seed

Miscellaneous Commodities
- Acerola
- Atemoya
- Asparagus
- Avocados
- Bananas
- Breadfruit
-Canistel
- Carambola
00038908, 00040087, 00044422
N/A
N/A
N/A
00038908, 00040087, 00044422, 00108203,
00109271, 40502601
40502603
00038908, 00040086, 00044426, 00108203,
00122715, 41484301
00150835
00038908,
00023336,
00040085,
00038908,
00038908,
N/A
00038908,
00109271,
00038908,
00122715
00076805,
00040087, 00044422, 00108203
00023512, 00037687, 00038908,
00048284, 00108203, 40502602
00040087, 00044422, 00108203
00040087, 00044422
00040087, 00044422, 00108203,
40502601
00040086, 00044426, 00108203,
00108147
00076805, 00108147
40541304
00108144, 40642401
00108149
00108175
40149401
40149401
28
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GLYPHOSATE RED
September 1993
Guideline/Commodity
--Ohefiffleya
- Cocoa beans
- Coconut
- Coffee beans
-Cotton

(processed commodities)
- Dates
- Figs
- Genip
- Guavas
- Jaboticaba
- Jackfruit
- Kiwi, .fruit
• LitcM N?*t (Lychee)
- Loagan
• Manrey Sepote
(Marmaes Apple)
• Mangoes
Olives
(processed commodities)
Palm oil
Papayas
Passion Fruit
Peanuts
(processed commodities)
Persimmons
Pineapple
Pistachio
Sapodilla
Sapote (black and white)
Soursop
Sugar apple
00051980,00051981
00060103, 00061553, 00108176, 00108153,
00108203
00061553, 00108176, 00108153
40149401
00059050
40149401
40149401
40580401
N/A
00108175, 42398401
00108175, 42398401

00063713

00144341, 00028852
00144341, 00028852
40149401
N/A
00111945

40149401
40149401
29
-------
GLYPnOSATE RED
September 1993
Guideline/Commodity
References'
- Sugarcane
(processed commodities)
- Tamarind
-Tea
- Watercress
§171-4 (h): Magnitude of the
Residue in Plants Resulting from
the Use of Irrigation Water
00108140
00108168
40149401
00078823, 00078824
N/A
00039381, 40541305
§171-4 (j): Magnitude of the Residue in Meat, Milk, Poultry, 00108115,40532001-03
and Eggs
§171-4 (g): Magnitude of the
Residue in Fish
§171-4(1): Nature and Magnitude
the Residue in Drinking and
Irrigation Water
§171-4 (i). Magnitude of the
Residue in Food Handling
Estab'Sshnjent

§171-5. Reduction of Residues
00036229, 00076491, 00154311, 00155120

00039377, 00039381, 00077227, 00077228,
00077229, 00077230, 00077231, 00077232,
00077233, 00077234, 00077235, 00077236,
00077237, 00077238, 00077301, 00108173,
1 N/A means not available by MRID number. Those guidelines/commodities which do not list a MRID
reference number, additional reference information can be provided from Table A in the Product and Residue
Chemistry Chapters by R.B. Perfetti, Chemistry Branch Registration Support (CBRSl 10665) in the Health
Effects Division dated 10/27/92 through FOI.
C. Environmental Assessment

1. Environmental Fate

a. Environmental Fate and Transport

(1) Hydrolysis
30
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GLVPHOSATE RED
September 1993
Glyphbsate is stable at pH 3, 6, 9 at 5 and 35 °C.
(Accession 00108192)

(2) Photodegradation in Water

Glyphosate is stable to photodegradation in pH 5,
7, and 9 buffered solutions under natural sunlight.
(MRID41689101)

(3) Photodegradation on Soil

Glyphosate is stable to photodegradation on soil.
(MRID 41335101)

(4) Aerobic Soil Metabolism

Data indicate half-life values of 1.85 and 2.06
days in Kickapoo sandy loam and Dupo silt loam
respectively. Aminomethyl phosphonic acid (AMPA)
was the major degradate, (MRID 42372501)

(5) Anaerobic Aquatic Metabolism

Glyphosate has a half-life of 8.1 days in anaerobic
(flooded plus nitrogen atmosphere) silty clay loam
sediment. AMPA was the major degradate. (MRID
42372502)

(6) Aerobic Aquatic Metabolism

Glyphosate has a half-life of 7 days in flooded
siity clay loam sediment that was incubated in the dark
at 24.6 ± 0.57 C for 30 days. AMPA was the major
degradate. (MRID 42372503)

(7) Leaching/Adsorption/Desorption

Kd values of 62, 90, 70, 22, and 175 were
reported for Drummer silty clay loam, Ray silt, Spinks
sandy loam, Lintonia sandy loam, and Cattail Swamp
sediment respectively. After (aged) leaching 7 soils with
20" of water, the recovered radioactivity in the soils
31
-------
GLXPIiOSATE RED
September 1993
(Accessions
was 93-100% of the applied material.
00108192, 00076493, 00108140)

(8) Terrestrial Field Dissipation
The Agency has received an interim report on a
terrestrial field dissipation study in progress by
Monsanto Company. (MRID 42607501)

This report contains data from eight different field
sites. Some of tha data from the individual field sites
are deficient; however, the Agency may use the data
from the eight field sites together to satisfy the
terrestrial field dissipation 164-1 data requirement.

The interim report results from the first 12 months
of bareground field dissipation trials from eight sites
show that the median half-life (DT50) for glyphosate
applied at maximum annual use rates (7.95 Ib a.e./acre,
10.7 Ib a.i./acre) was 13.9 days with a range of 2.6
(Texas) to 140.6 (Iowa) days. Acceptable aerobic soil,
aerobic aquatic and anaerobic aquatic metabolism
studies demonstrate that under those conditions at
25°C in the laboratory glyphosate degrades rapidly with
half-lives of approximately 2, 7 and 8 days respectively.
The reported half-lives (DT60) from the field studies
conducted in the coldest climates, ie. Minnesota, New
York and Iowa, were the longest at 28.7, 127.8, and
140.6 days respectively indicating that glyphosate
residues in the field are somewhat more persistent in
cooler climates as opposed to milder ones (Georgia,
California, Arizona, Ohio, and Texas).

Glyphosate (as well as AMPA) was shown to
remain predominantly in the 0-6 inch soil layer
throughout the duration of the study at all field sites.
Iowa was the individual test site to have average
glyphosate residues, at alf sampling times, greater than
0.01 ppm in the 6-12 inch depth. There were a number
of detections from 0.01 to 0.09 ppm in the 6-12 inch
layer in Minnesota, New York and Texas, and
32
-------
GLYPHOSATE RED
September 1993
glyphosate was detected at generally <0.05 ppm at the
other 5 field sites (6-12 inch depth).

Glyphosate was detected at three different sites
below 12 inches. In California, at 0 DAT, average
glyphosate residues were 0.21 ppm and 0.10 ppm in
the 12-18 and 18-24 inch soil horizons respectively.
Soil core contamination was attributed to these
detections since movement of residues to this depth on
the first day of sampling is unlikely. In Arizona at 21
DAT the average glyphosate residues were 0.06, in the
18-24 inch soil layer. There were no glyphosate
residues in the 6-12 or 12-18 inch soil layer in Arizona
on 21 DAT and in subsequent samples below 12 inches
which may indicate a problem with sampling technique.
In Iowa at 190 DAT the average glyphosate residues
were 0.05 ppm in the 12-18 inch soil layer. Since there
were no glyphosate residues detected in the 6-12 inch
soil layer at 190 DAT, and the lack of a significant
amount of rainfall between sampling intervals in
combination with the amount of time between sampling
intervals and the high adsorptive characteristics of
glyphosate give an indication that there may have been
a problem with sampling technique.

AMPA was also shown to remain predominantly
in the 0-6 inch soil layer. AMPA was found at every
test site on Day 0 samples indicating the rapid
degradation of parent glyphosate. the AMPA levels
generally reached a maximum between day 14 and day
30. Where the field half-lives were longer (Iowa,
Minnesota, New York), the maximum average AMPA
levels occurred between 62 and 95 DAT. The
maximum average AMPA levels found in the 0-6 inch
soil layer were 0.6 ppm and occurred in Ohio and
Georgia at 21 DAT and 61 DAT respectively. The
AMPA levels at those sites had decreased to 0.12 and
0.44 ppm at 12 months after treatment.

In all samples but three, AMPA residue levels
vvere <0.05 ppm in the 6-12 inch soil layer. In New
York at 14 and 30 DAT average residues were detected
33
-------
GLYPUOSATE RED
September 1993
at 0.06 ppm. In Iowa at the 92 DAT sample average
AMPA residues were 0.08 ppm. Iowa and New York
also exhibited 50% dissipation times of 140.6 and
127.8 days respectively.

AMPA levels were detected at 0.06 ppm in the
18-24 inch soil layer on 21 DAT in Arizona and 0.04
and 0.03 ppm in the 12-18 inch soil layer at 90 and 180
DAT respectively in New York.

A final report on the terrestrial field dissipation
study showed the median half-life (DT^) (of eight sites)
of AMPA was 240 days with a range of 119 (Ohio) to
958 (California) days. The half-lives for the dissipation
of AMPA for seven of the eight test sites were:
Arizona
California
Georgia
Minnesota
New York
Ohio
Texas
142 days
958 days
896 days
302 days
240 days
119 days
131 days
Iowa was not calculated because recharging of AMPA
residues was greater than degradation. AMPA was
shown to remain predominantly in the 0-6 inch soil layer
throughout the duration of the study at all eight field
sites. AMPA was detected three times (at a
concentration greater than 0.05 ppm) at depths greater
than 12 inches. The three detections were attributed to
contamination during sampling rather than vertical
mobility.

(9) Aquatic Field Dissipation

Glyphosate dissipated from water (irrigation
source) with a calculated half-life of 7.5 days and 120
days from the sediment of the farm pond in Missouri.
(MRID 40881601)
34
-------
GLYPHOSATE RED
September 1993
In Michigan, Georgia and Oregon pond and stream
water, the maximum glyphosate concentrations were
measured immediately posttreatment and dissipated
rapidly. Glyphosate accumulated in the pond sediment
and to a lesser extent in the stream sediments;
glyphosate was present in pond sediment at s= 1 ppm in
Michigan and Oregon at approximately 1 year
posttreatment. (MRID 41552801)

(10) Forestry Dissipation

When aerially applied at 3.75 Ib/A to forested
sites in Michigan, Oregon, and Georgia, glyphosate
averaged 652-1273 ppm in tree foliage immediately
posttreatment. It then declined rapidly with half-lives of
<1 day at the Michigan and Georgia sites and < 14
days at the Oregon site.

The forestry dissipation study results demonstrate
that when used under normal silviculture practices
according to label directions, the maximum combined
glyphosate and AMPA residue level in soil is less than 5
ppm. Glyphosate and AMPA residues in soil dissipate
with time. The average half-life for the dissipation of
glyphosate was 100 days, and ranged from 35 to 158
days. The average half-life for the dissipation of AMPA
was 118 days, and ranged from 71 days to 165 days.
(MRID 41552801)

(11) Accumulation in Confined Rotational Crops

Glyphosate residues (expressed as fresh weight)
accumulated in lettuce, carrots, and barley planted 30,
119, and 364 days after sandy loam soil was treated
with glyphosate at 3.71 Ib ai/A. Accumulation
decreased as the length of the rotation increased. In
crops planted at 30 days, posttreatment, [14C]residues
at harvest were 0.097 ppm in lettuce, 0.051 and 0.037
ppm in carrot tops and roots, respectively, and 0.188
and 0.175 ppm in barley grain and straw, respectively.
In immature lettuce harvested at 40 and 60 days
postplanting, [1*C]residues were 0.108 and 0.048 ppm,
35
-------
GLVPHOSATE RED
September 1993
respectively. In crops planted at 119 days
posttreatment, [14C]residues at harvest were 0.037 ppm
in lettuce, 0.028 and 0.017 ppm in carrot tops and
roots, respectively, and 0.078 and 0.056 ppm in barley
grain and straw, respectively. In immature lettuce
harvested at 28 and 48 days postplanting, [14C]residues
were 0.059 and 0.055 ppm, respectively. In crops
planted at 364 days posttreatment, [14C]residues at
harvest were 0.028 ppm in lettuce, 0.018 and 0.0096
ppm in carrot tops and roots, respectively, and 0.047
and 0.061 ppm in barley grain and straw, respectively.
In immature lettuce harvested at 35 and 61 days
postplanting, [14C]residues were 0.057 and 0.043 ppm,
respectively; in barley forage harvested at 48 days
postplanting, [14C]residues were 0.056 ppm. (MRID
41543201 and 41543202)

(12) Accumulation in Irrigated Crops

Alfalfa, corn (grain and forage), grass {fescue or
sudan) and lettuce were irrigated five to eight times
during the 1987 growing season with glyphosate treated
water containing a maximum of 21.3 ppm (on treatment
day then fell to 0.46 ppm by 1 day after treatment) of
glyphosate. Residues in the sediment beneath the
treated water reached a maximum of 3.5 ppm at 14
days after treatment. Residues of glyphosate in the
sprinkler water at the pond site were the highest 7 days
after treatment at 0.12 ppm. One lettuce sample from
the Missouri location (the pond site) at 29 days after
treatment (of water source) and 5 irrigation events was
found to contain 0.06 ppm glyphosate. (MRID
40541305)

(13) Bioaccumulation in Fish

Maximum bioconcentration factors were 0.38X
for edible tissues, 0.63X for nonedible tissues, and
0.52X for whole fish. (MRID 41228301)
36
-------
GLYPHOSATE RED
September 1993
(14) Laboratory and Field Volatility

The requirement of these studies was waived
based on the low vapor pressure of glyphosate.

b. Environmental Fate and Groundwater Assessment

In general, the available field and laboratory data indicate
glyphosate adsorbs strongly to soil and would not be expected
to move vertically below the 6 inch soil layer. Based on
unaged batch equilibrium studies glyphosate and glyphosate
residues are expected to be immobile with Kd(ad., values
ranging from 62 to 175. The mechanism of adsorption is
unclear; however, it is speculated that it may be associated
with Vacant phosphate sorption sites or high levels of metallic
soil cations. The data indicate that chemical and
photochemical decomposition is not a significant pathway of
degradation of glyphosate in soil and water. However,
glyphosate is readily degraded by soil microbes to aminomethyl
phosphonic acid (AMPA), which is degraded to CO2, although
at a slower rate than parent glyphosate. Even though
glyphosate is highly water soluble it appears that parent
glyphosate and AMPA have a low potential to move to ground-
water due to their strong adsorptive characteristics
demonstrated in the laboratory and field studies. However,
glyphosate does have the potential to contaminate surface
waters due to its aquatic use patterns and erosion via transport
of residues adsorbed to soil particles suspended in runoff
water. If glyphosate were to reach surface water it would be
resistant to hydrolysis and aqueous photolysis.

Based on the low vapor pressure of glyphosate,
volatilization from soils will not be an important dissipation
mechanism. The low octanol/water coefficient suggests that
glyphosate will have a low tendency to accumulate in fish.

2. Ecological Effects

a. Ecological Hazard
37
-------
GLYPIIOSATB RED
September 1993
(1) Effects to Nontarget Birds

To establish the toxicity of glyphosate to birds,
tests were required using the technical grade material.

(a) Avian Single-Dose Oral LD50 - Technical
Acute Oral Toxicity Findings
Conclusions
••••«•
practically non-toxic to upland game birds
LDj, (95% CL)
••MM
> 2000 mg/kg
Bobwhite
quail
One avian single-dose oral study on either a waterfowl species (preferably maUardI duck) or an
upland species (preferably bobwhite quail) was required. These data indicate ttiat technical
SosateS practically non-toxic to an upland bird species on an acute oral basis. The guidehne
requirement for an avian acute oral study is fulfilled. (Study ID 234395)
(b) Avian Dietary - Technical
Avian Subacute Dietary Toxicity Findings
Species
Mallard duck
Bobwhite
quail
AI
98.5%
Tech
98.%
Tech
Reproductive
Impairment
•••«•
> 4640 ppm
> 4640 ppm
Conclusions
no more than slightly toxic to upland game birds and
waterfowl
Two subacute dietary studies, one study on a species of waterfowl (preferably
one on an upland game bird species (preferably a bobwhite quail), were required. These data
Ldkate thai the technical glyphosate is no more than slightly toxic to birds on adjetary^bas*.
The guideline requirement is fulfilled for both studies. (Study IDs 94171 and 00086492)
38
-------
GLYPHOSATB RED
September 1993
(c) Avian Reproduction
Bobwhite
quail
% AI
83%
Tech
90.456
Tech
83%
Tech
Avian Reproduction Findings
Reproductive
Impairment
mmmaumm
No effects up to 1000
ppm
No effects up to 30
ppm
No effects up to 1000
ppm
Conclusions
not expected to cause reproductive impairment
An avian reproduction test was required to support registration of the end-use products of
glyphosate since the following guideline criteria have been exceeded. The labeling for several use
patterns contains directions for use under which birds may be subject to repeated exposure to
glyphosate, The labeling allows repeat application for certain uses, such as alfalfa, barley, oats
apples, cherries, and oranges. These data indicate thai technical glyphosate is not expected to
cause reproductive impairment. The guideline requirement for an avian reproduction study on
both upland game bird and waterfowl are fulfilled. (Study IDs 235924, 00036328, and 235924)

(d) Summary of Findings

Glyphosate is practically non-toxic to
bobwhite quail on the basis of acute oral toxicity.
An LDso greater than 2000 mg/kg was determined
for bobwhite quail given a single oral dose of
technical glyphosate. Studies indicate that the 8-
day dietary LCgo of the chemical is greater than
4000 ppm for both mallard ducks and bobwhite
quail. These data indicate that the chemical is
slightly toxic to birds. Avian reproduction studies
indicate reproductive impairment would not be
expected at a dietary level of up to 1000 ppm.
The available acute toxicity data do not indicate
a requirement of precautionary labeling for birds
on products containing glyphosate.
39
-------
GLYPHOSATB RED
September 1993
(2) Effects on Non-Target Fish

(a) Acute Toxicity to Freshwater Fish
••••••••••••
Species
HHB^^BRBIHOBIBHB
Bluegill sunfish
Fathead
Minnow
Bluegill sunfish
Rainbow Trout
Rainbow Trout
Fatheai
minnow
Channel catfish
Bluegiil sunfish
1
mmmmmm
% AI
mmmm
96.5%
87.3%
83%
83%
96.7%
96.7%
96.7%
96.7%
toite Toxicity to Freshwater Fish Findings -••.;. ' " •. • ^'W**,
48-hr LC»
(95%CL)
•BSEHSHBn
> 24 mg/1
84.9 mg/1
(72.9-99.3)
120 mg/1
(111-130)
86 mg/1 (70-
106)
140 mg/1
(120-170)
97 mg/1 (79-
120)
130 mg/1
(110-160)
140 mg/1
(110-160)
Conclusions
HI • •••••••••••••••••••••••
ranges in toxicity from slightly non-toxic to practically non-
toxic to both cold water and warm water fish
The minimum data required for establishing the acute toxicity of glyphosate to freshwater fish
are the results of two 96-hour studies with the technical grade product. One study was to be
performed on a cold water fish species (preferably rainbow trout) and. one study was to be
performed using a warm water species (preferably bluegill sunfish). The results of these eight
studies indicate that technical glyphosate is slightly to practically nontoxic to both cold water and
warm water fish. The guidelines requirement for acute toxicity testing of the technical OB
freshwater fish is fulfilled. (Study IDs 00108112, 00108171, 234395, 097661, and 249160)
40
-------
GLVPBOSATB RED
September 1993
(b) Chronic Toxicity to Freshwater Fish
Chronic Toxiclity to Freshwater Fish Findings
Species
Fathead
Minnow
% AI
87.3%
tech
Results
MATC > 25.7 mg/1
Conclusions
no effects at or below this level
One «.o the aquatic us® of the chemical, Its presence in water is likely to be continuous or
recurrent regardless of toxicity; therefore, chronic testing was required. This fish full life cycle
study satisfies the generic guideline requirement for chronic freshwater fish testing. (Study ID
00108171)
Acute Toxicity to Freshwater Fish
Findings from Studies using Formulated Products
Speeiss
% AI
(3IPA salt)
96-hr
(95% CL)
Conclusions
Bluegill
sunfish
Rainbow
Troui
catfish
Rainbow
Trout
Bluegill
sunfish
Fathead
Minnow
Rainbow
Trout
Bluegill
sunfish
41.J
41.8%
41.36%
41.36
41.36%
41.36%
62.4%
62.4%
5.8 mg/1 (4.4-
8.3)
8.2 mg/1 (6.4-
9.0)
16 mg/1 (9.4-
26)
11 mg/1 (S.7-14)
14 mg/1 (8.7-
24)
9.4 mg/1 (5.6-
16)
> 1000 mg/1
> 1000 mg/1
ranges in toxicity from moderately toxic to practically non-
toxic to both warmwater and coldwater fish
41
-------
GLTfPUOSATB RED
September 1993
Acute Toxicity to Freshwater Fish
Findings from Studies using Formulated Products
"Rainbow
Trout
Rainbow
Trout
Bluegill
sunfish
Bluegill
sunfish
Rainbow
Trout
Bluegill
sunfish
Rainbow
Trout
Fathead
minnows
Rainbow
Trout
Bluegill
sunfish
Channel
catfish
Bluegill
sunfish
Rainbow
Trout
TI:Z* -
+ 15.3
"AA"
surfactant
*40.7%
+ 15%
•W"
surfactant
*40.7%
+ 15%
•W"
surfactant
*41.2%
+ 15.3%
•AA'
surfactant
7.03% 4-
0.5% "X-
77"
7.03% +
0.5% "X-
77"
51%
41%
41%
41%
41%
41%
41%
"izo mgn tsb-
180)
150 mg/1 (100-
320)
> 100 mg/1
> 180 mg/1
240 mg/1 (180-
320 mg/1)
830 mg/1 (620-
1600)
8.3 mg/1 (7.0-
9.9)
2.3 mg/1 (1.9-
2.8)
9.0 mg/1 (7.5-
11)
4.3 mg/1 (3.4-
5.5)
13 mg/1 (11-16)
5 mg/1 (3.8-6.6)
1.3 mg/1 (1.1-
16)

42
-------
GLYPHOSATE RED
September 1993
Testify of an end-use product is required if the pesticide will be introduced directly into an
aquatic environment when used as directed by the label. Drainage systems would be included
in such a category. Therefore, formulated product testing was required. According to the
surfactant selected, the formulated product toxicity ranges from moderately toxic to practically
non-toxic. (Study ID 249159, 00070894, 00070895, 00070897, 00070896, 00078661, 00078662,
00078658, 00078655, 00078656, 00078659, 00078664, 00078665, 249160)
Surfactant test Findings
Species
Fathead
minnow
Rainbow
trout
Rainbow
Trout
Channel
Catfish
BluegiU
suufish
BluegiJi
sunfish
% AI
MON0818
Tech 10056
MONO818
Tech 100%
MONO818
MONO818
Tech 100%
MONO818
Tech 100%
MONO818
Tech 100%
96-hour LCJt
(95% CL)
1.0 mg/1 (1.2-
I'.T)
2.0 mg/1 (L5-
2.7)
0.65 mg/1 (.54-
.78)
13 mg/1 (10-
17)
3.0 (2,5-3.7)
1 mg/1 (.72-
1.4)
Conclusions'
ranges in toxicity from highly toxic to slightly toxic to
warmwater and coldwater fish
Testing of the surfactant may be required under unusual circumstances. When inerts are likely
to be toxic, testing can be required. These data indicate that MONO818 ranges from moderately
toxic to very highly toxic to both cold and warm water fish after 96 hour exposure. (Study ID
249160)

Three tests on warm water species, one
bluegill and two with fathead minnow, produced
the 96-hour LC50s of 120 ppm, 84.9 ppm, and 97
ppm, respectively (McAllister and Forbis 1978, ID
#234395; EG & G Bionomics 1975, ID
#00108171 and Folmar, Sanders, and Julin
1979, ID #249160). Two rainbow trout 96-hour
LCgoS provided values of 86 ppm and 140 ppm.
Based on these tests, technical glyphosate ranges
43
-------
GLYPBOSATS RED
September 1993
from slightly to practically non-toxic to freshwater
fish species.

Surfactant testing was performed with both
cold water and warm water fish. In this case, the
initial formulation demonstrated ah application
rate much lower than technical glyphosate. The
LC50 for rainbow trout was 1.3 mg/l or
moderately toxic. The surfactant (MON0818)
when tested alone produced an LC^ value of
0.65 mg/l for rainbow trout indicating a highly
toxic category (Folmar et al. 1979, ID #249160).
In contrast, the formulation of 41.2 percent
isopropylamine salt and 15.3 percent "AA"
surfactant provided a rainbow trout LC^ of 120
mg/l, indicating a practically non-toxic compound
(Thompson and Griffen 1980, ID #00078658).
Bluegill are in the same category of toxicity with
an even higher LC^ of greater than 180 mg/l
{Thompson and Griffen 1980, ID #00078659),
The bluegill and rainbow trout were similar in
sensitivity to the formulation containing the "W"
surfactant with LCgo values of 150 and >100
mg/l, respectively. Also, neither rainbow trout
(LCSO 240 mg/l) nor bluegill (LC^ 830 mg/l) were
very sensitive to the x-77(;S| surfactant and
glyphosate(7.03%).

The surfactant MON0818 has been tested
separately, producing an LCeo of 13 mg/l on
Chironomous indicating it is a slightly toxic
material. For fish, the catfish appears to be the
most tolerant with an LC50 value of 13 mg/l, and
rainbow trout the most sensitive with an LC^
value of 0.65 mg/l. Based upon available data
products containing MON08I8 must include the
statement, "This pesticide is toxic to fish."
44
-------
GLYPHOSATE RED
September 1993
(3) Effects on Aquatic Invertebrates

(a) Acute Toxicity to Freshwater Invertebrates
Acote Toxicity to Freshwater Invertebrates findings
Species
Daphnia magna
Chironomus
plumosus
% AI
83% tech
96.7%
tech
48-hr LCW (ppm)
780
55 (31-97)
Conclusions •
ranges in toxicity from slightly toxic to
practically noa-toxic to freshwater
invertebrates
The minimum data requirement to establish the acute toxicity of glyphosate to freshwater
invertebrates is a 48-hour acute study using the technical material. Test organisms should be
first instar Daphnia magna or early instar amphipods, stone flies or mayflies. The results of
these studies indicate that technical glyphosate is slightly toxic to Chironomus plumosus and is
.practically non toxic to Daphnia magna. The guideline requirement for acute testing on a
freshwater invertebrate has been fulfilled. (Study ED 00108172, and 249160)

(b) Chronic Toxicity to Freshwater Invertebrates
Chronic Toxicity to Freshwater Invert ebrates Findings
Species
Daphnia magna
•'• %AT
99.7%
tech
Results
MATC > 50 -
< 96 mg/L
Conclusions
caused reduced reproductive capacity
Due to the aquatic use of the chemical its presence in water is likely to be continuous or
recurrent regardless of toxicity; therefore, chronic testing was required. This study satisfies the
guideline requirement for chronic freshwater invertebrate testing. (Study ID 2491(0)
, , • " Acute Toxicity to Freshwater Invertebrates
Findings from Studies using Formulated Products
Species
Daphnia magna
% AI
(IPAsalt)
62.496
48-hir LCj,
(ppm)
869 (703-
1019)
Conclusions
ranges in toxicity from moderately toxic to practically non-
toxic to freshwater invertebrates
45
-------
GLYPHOSATB RED
September 1993
Acute Toxicity to freshwater Invertebrates > 1
Findings from Studies using Formulated Products :i |
Daphnia magna
Daphnia magna
Daphnia magna
Daphnia magna
Gammarus
pseudolimnactus
Chironomus
plumosus
Daphnia pulex
Daphnia magna
Gammarus
pseudolimnaeus

Ephemerella
walkeri
7.03% +
X-77
surfactant
©0.5%
41.2% +
"AA" ,
surfactant
@ 15.3 %
40.7%
MON213
9 + 15%
"W"
surfactant
41%
41%
41%
51%
MON
2139
41.36%
41.83%

41%
>1000
310 (250-
400)
72 (62-83)
3 (2.6-3.4)
62 (40-98)
18 (9.4-32)
242(224-
261.5)
5.3 (4.4-
6.3)
41.9 (30.7-
62)
Other
results
Mayfly
nymphs
avoided
glyphosate
at
concentratio
nsof 10
mg/L but
not at 1.0
mg/1.

46
-------
GLYPHOSATS RED
September 1993
Acute Toxlcity to Freshwater Invertebrates
Findings from Studies using Formulated Products
Chironomus
plumosus
41%
Significant
increases in
stream drift
of midge
larvae was
observed
after the
2.0 mg/1,
but not at
the 0.02 or
0.2 mg/1
level.
Testing of an end-use product is required if the pesticide will be introduced directly into an
aquatic environment when used as directed bj the label. Drainage systems (wet and dry) would
be included in such a category. Therefore, formulated product testing was required. According
to the surfactant selected, the formulated product toxicity ranges from moderately toxic to
practically non-toxic. (Study ID 00078663, 00078666, 00078660, 00078657, 249160, 00108109,
00070893, and 249159)
Surfactant Test Findings
Species
Daphnia
magna
% AI
100%
MONO818
surfactant
48-hr LCj.
(95%CL)
13mg/L
(7.1-24)
Conclusions
slightly toxic to freshwater invertebrates
Testing of the surfactant may be required under unusual circumstances. One test on the
surfactant was received and determined as acceptable for use in a risk assessment (Study ID
249160)

(d) Summary of Findings

A 48-hour LC^ of 780 ppm (mg/l) was
found for Daphnia magna exposed to technical
glyphosate (McAllister and Forbis 1978, ID
#00108172). The results of this study indicate
that the chemical is practically non-toxic to
aquatic invertebrates.
47
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GLYPHOSATE RED
September 1993
In addition to these acute studies, a fish
life-cycle study indicates technical glyphosate has
a MATC greater than 25.7 ppm. No effect was
observed at the highest level tested. A Daphnia
magna life cycle study with an MATC of > 50 -
<96 ppm reported reduced reproductive
capacity, the most sensitive parameter.

The available acute toxicity data indicate
that precautionary labeling for freshwater
intervertebrates is not required for products
containing glyphosate.

In order to determine the effect of the three
surfactants ("W
AA", and "X-77") on
invertebrates, additional Daphnia studies were
conducted. The 7.03 percent isopropylamine salt
of glyphosate with a surfactant at 0.5 percent
identified as X-77 resulted in an LCgo of greater
than 1000 mg/l or practically non-toxic category
for Daphnia. The second combination was 41 .2
percent isopropylamine and 15.3 percent of a
surfactant identified as "AA." This LCgo was 310
ppm which would indicate it is practically non-
toxic to Daphnia. The third combination
consisted of 40.7 percent isopropylamine and 1 5
percent of a surfactant identified as "W." The
resultant LCgo of 72 ppm reveals that this material
is slightly toxic to Daphnia.

A glyphosate formulation was tested
several times with different invertebrates. The
LC50 values ranged from 3 mg/l for Daphnia to 62
mg/l for Gammarus indicating a moderately toxic
material for Daphnia and no more than slightly
toxic for Gammarus.

(4) Effects on Marine/Estuarine Organisms
48
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GLYPHOSATB RED
September 1993
(a) Acute Toxicity

Acute toxicity testing for estuarine and
marine organisms on technical glyphosate is
required. The guidelines require estuarine and
marine studies when exposure of such waters is
likely. Crops, such as cotton, corn, sugarcane,
turf, citrus, berries, forestry, sorghum,
watermelon, etc. would allow this type of
exposure to occur.

Acute toxicity testing for estuarine and
marine organisms on formulated glyphosate may
be required when exposure to estuarine and
marine water is expected. The use in drainage
systems (wet or dry) would allow this type of
exposure. Minimum requirements are results
from testing the technical on one estuarine fish
(96 hrs LCgo) and either a 48 hrs oyster larvae
study or a 96 hrs shell deposition study. Again,
since there is such an extensive data set for this
chemical, the Agency can determine that
glyphosate demonstrates low toxicity to fish and
oyster species, and therefore is waiving the
marine fish and oyster acute toxicity studies on
the formulated product.
Acute Toxicity to Estuarine and Marine Organisms findings
Species
% AI
Results
Conclusions
Grass shrimp
96.7%
tech
LCa 281 ppra
(207-381)
ranges in toxicity from slightly to practically non-toxic to
marine organisms
Fiddler crab
96.7%
tech
LCgj 934 ppm
(555-1570)
Atlantic oyster
96.7%
tech
TL» > 10
mg/L for 48
hours
These data on marine/estuarine species are acceptable for use in a risk assessment. These data
indicate that technical glyphosate is practically non-toxic to grass shrimp, fiddler crab, and
49
-------
GLYPHOSATB RED
Sfptanber 1993
slightly tone to the Atlantic oyster. Acute toxicity testing on an estuarine fish species is nonnally
required. However, since there is such an extensive data set for this chemical, the Agency can
determine that glyphosate demonstrates low toxicity to fish species, and therefore is waiving the
marine fish acute toxicity study. (Study ID 00108110, and 00108111)

(b) Summary of Findings

A series of studies were performed on
marine/ estuarine species. A 96-hour LCgo of 281
ppm was determined for grass shrimp
(Palaemonetas vulgaris). In a study on fiddler
crabs (Uca pugilator), it was determined that the
96-hour LCgo is 934 ppm glyphosate. Both of
these studies indicate technical glyphosate is
practically non-toxic to grass shrimp and fiddler
crabs. An embryo-larvae 48-hour TLgo for
Atlantic oyster greater than 10 ppm indicating
glyphosate is slightly toxic.

(5) Effects on Non-Target Insects

(a) Acute Toxicity Testing
/! •• •./V bj*S%)?jf *•? •• y.,V ,, ~,,.. •„ «, ",'
Acute Toxicity to Honeybees Data , , , ;-, •»
Speues
Honeybee
acute oral
Honeybee
acute oral
Honeybee
acute contact
Honeybee
acute contact

AI%
tech*CP67573
36 %
MON2139
tecb*CP67573
36 %
MON2139
Results
oralLDsj >
lOOftg/bee
oralLDjo >
lOOjig/bee
contact LDsj
> lOOjig/bee
contact LDn
> 100/tg/bee
Conclusions
practically non-toxic to honeybees on an acute oral and
acute contact basis
* - The percentage of active ingredient used was not reported.
The guidelines require acute toxicity testing to honeybees on the technical when a herbicide is
registered as a general use herbicide. Given the multitude of use patterns for which this chemical
is registered, acute honeybee toxicity studies are required. Based on these data, glyphosate
(CP67573) is considered practically nontoxic on the basis of acute contact toxicity, as well as on
50
-------
GLYPHOSATE RED
September 1993
acute oral toxicity. These data satisfy guideline requirements for nontarget insect studies when
glyphosate is used as a general use herbicide,, (Fiche No. 00026489)
Four studies were conducted, two on
technical glyphosate and two on the formulation
MON2139, consisting of 36 % active ingredient.
Results from the honeybee acute oral toxicity
study indicates both technical and formulated
glyphosate are practically nontoxic to the honey
bee with IDa, values greater than 100 //g/bee.
Results from the honeybee acute contact toxicity
study indicates both technical and formulated
glyphosate are practically nontoxic to the honey
bee with LDso values greater than 100 //g/bee.

(6) Effects to Non-Target Plants

When a herbicide is applied as a terrestrial
nonfood use, aquatic nonfood use, or as a forestry use,
Tier I nontarget phytotoxicity studies are required in
order to evaluate the effects of the herbicide on
nontarget plants.

(a) Phytotoxicity Testing
Effects on Non-Target Plant Findings
Specks
Selenastnm
capricornutum
Navicula
pelliculosa
Skeletonema
costatum
Anabaena, flos-
aquae
%AI
96.6
96.6
96.6
96.6
Results
4 day EC* =
12.5 mg/1
4 Day EC*, =
39.9 mg/1
4 day EC* ==
0.85 mg/1
4 day ECX -
11.7 mg/1
51
-------
CLYPHOSATS RED
September 1993
(Effects on Non-Target Plant Findings
Lemna gibba
96.6
7 day EC* =
21.5 mg/1
Based on the results of the preceding studies, the data indicates that the 4 day ECM ranged from
0.85 mg/I to 39.9 mg/1 for four aquatic plant species, and a 7 day EC,, of 21.5 mg/1 for one
aquatic species. Based on the data submitted, the requirements for Tier I and Tier n Aquatic
Plant Growth Studies (122-2 and 123-2) have been fulfilled.

A seed germination/seedling emergence study was conducted (MRID 40159301) on isopropylamine
salt of glyphosate CP-70139 (Tech) 50% acid basis. The results indicate that CP-70139 applied
at a rate up to 10.0 Ib ai/A resulted in < 25 % effect on the spectrum of monocots and dicots
tested. Based on the results of this study, Tier I data requirements for seed germination/seedling
emergence guideline reference 122-1 have been satisfied. (MRJDs 40236901,40236902,40236903,
40236934, and 40236905)

(b) Summary of Findings

Based on the results of the aquatic plant
growth studies which were conducted on 5
species, the data indicates that the 4 day EC^
ranged from 0.85 mg/1 to 39.9 mg/1 for four
aquatic plant species, and a 7 day ECgo of 21.5
mg/I for one aquatic species.

Based on the use patterns, the method of
application, and the chemical properties of
glyphosate, additional studies are required to
evaluate the effects on nontarget plants. The
recommended labels do not preclude off-target
movement of glyphosate by drift. Nor do they
address the potential off-target movement via
terrestrial plants as well as aquatic plants.
Therefore, the Agency is requiring terrestrial plant
test data to assess potential risk to nontarget
plants. The data required are the Tier II
52
-------
GLYPHOSATB RED
September 1993
Vegetative Vigor Guideline Reference No. 123-1.
In addition, droplet size spectrum (201-1) and
drift field evaluation (202-1) data are required.

These three guideline studies, Vegetative
Vigor, Droplet Size Spectrum, and Drift Field
Evaluation are not considered part of the target
data base for reregistration. These data do not
affect the reregistration eligibility of glyphosate.
!f, upon review of the data from these studies,
modification in use practices and/or precautionary
measures are necessary, the Agency will require
all registrants to make label changes as
appropriate.

b. Ecological Effects Risk Assessment

Based on the current data, it has been determined that
effects to birds, mammals, fish and invertebrates are minimal.
Under certain use conditions, glyphosate is expected to cause
adverse effects to nontarget aquatic plants. Additional data
are needed in order to fully evaluate the effects of glyphosate
on nontarget terrestrial plants. This includes results from
vegetative vigor testing (123-1), droplet size spectrum (201 -1).
In addition, the drift field evaluation (202-1) study must be
submitted and reviewed. Risk reduction measures cannot be
recommended until data are submitted and evaluated.

(1) Non-Endangered Species

(a) Terrestrial Species

The acute oral LD50 found for bobwhite
quail dosed with technical glyphosate is greater
than 3851 mg/kg. This indicates that the
chemical is practically non-toxic to an upland
game species. On a dietary basis, the available
data indicate that, at most, technical glyphosate
is slightly toxic to both mallards and bobwhite
(LCgo > 4640). The articles of Hoerger and
Kenaga (1972) and Kenaga (1973) were
consulted in order to estimate the maximum
53
-------
GLYPHOSATB RED
September 1993
concentration of glyphosate which may occur at
the highest application rate for such sites as,
cotton and corn. The following chart addresses
the major vegetation categories upon which fauna
are expected to feed.
Feed Category Concentrations (ppm)
@ 5.0625 Ibs ai/A
Short grass
Long grass
Leafy crops
Forage; small insects
Pods; large insects
Fruit
1215
557
632
294
61
35
Comparing these residues to the dietary data for both
bobwhite and mallards (LC^ > 4640; 1/5th the LC^ > 928),
higher use rates may produce potentially toxic residues on
short grass only (assuming the LC50 is just over > 4640).
Wildlife ingesting significant amounts of insects, pods and/or
fruits should not be affected by single applications.

Directions for some of the use patterns do indicate that
applications can be repeated. Multiple treatments could
potentially increase residues on dietary items within an
extended time period. Also, the available information suggest
that glyphosate is relatively persistent. The half-life in soil is
as high as 90.2 days. However, avian reproduction studies
demonstrated no adverse effects at the highest level tested,
1000 parts per million. Similarly, 90-day dietary studies with
dogs and rats indicate no significant abnormalities when the
maximum level tested is 2000 parts per million. Based on this,
minimal risk is expected.
54
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GLYPHOSATE RED
September 1993
(b) Aquatic Species

Aquatic organisms do not appear to be
sensitive to technical glyphosate. The most
sensitive aquatic invertebrate tested is
Chironomus plumosus with a 48-hr LCgo of 55
ppm which is very near to the lower limit of the
Daphnia chronic MATC of 50 mg/l. The most
sensitive fish species are fathead minnow and
rainbow trout which have 96-hour LC^s of 84.9
and 86 mg/l. Chronic testing for the technical
with fathead minnow provided an MATC of >
25.7 mg/l. Based on the toxicity and the various
EEC's the Agency has determined technical
glyphosate should not cause acute or chronic
adverse effects to aquatic environments.
Therefore, minimal risk is expected to aquatic
organisms from the technical glyphosate.

A seed germination/seedling emergence
study was conducted on isopropylamine salt of
glyphosate CP-70139 (Tech) 50% acid basis.
The results indicate that CP-70139 applied at a
rate up to 10,0 !b ai/A resulted in < 25 % effect
on the spectrum of monocots and dicots tested.
Considering the use patterns that are terrestrial
food crop and non-food crop the above EEC's
were considered for evaluating the effects to
nontarget plants. The highest exposure of 0.404
Ib a.i. (from aerial application, mist blower and
sprinkler irrigation) is well below the 10.0 Ib a.i./A
rate which resulted in < 25 % effect on the
monocots and dicots tested. Therefore, it has
been determined that the use of glyphosate is not
expected to cause adverse effects on seed
germination/seedling emergence with the various
registered use patterns. (MRID 40159301)
55
-------
GLYPBOSATB RED
September 1993
No vegetative vigor (123-1) plant studies
have been conducted. Based on the use
patterns, the method of application and the
chemical properties of glyphosate, additional
studies are required to evaluate these effects on
nontarget terrestrial plants. The recommended
labeling precautions do not preclude off-target
movement of glyphosate by drift. To assess
potential risk to terrestrial plants the Agency is
requiring additional terrestrial plant test data,
including results from vegetative vigor testing,
droplet size spectrum testing and drift field
evaluation. These data are not part of the target
data base for reregistration. Risk reduction
measures cannot be recommended until data are
submitted and evaluated. If, upon review of the
data from these studies, modification in use
practices and/or precautionary measures are
necessary, the Agency will require all registrants
to make label changes as appropriate.

The aquatic EEC from direct application of
3.72 ppm was used to estimate exposure. Based
on the results of the aquatic macrophyte toxicity
data, the 4 day EC50 was reported to be as low as
0.85 ppm indicating that there may be adverse
effects to nontarget aquatic plant species.

(2) Endangered Species

Based on the toxicity data and the estimated
exposure, it is not expected that endangered terrestrial
or aquatic organisms will be affected from the use of
glyphosate on the registered uses since the EEC's are
well below the endangered species criteria (birds =1/10
LCgo, aquatic organisms = 1/20LCBo). However, many
endangered plants may be at risk from the use of
glyphosate on the registered use patterns. In addition,
as discussed in the 1986 Glyphosate Registration
Standard, it was determined that based on habitat, the
Houston Toad may be at risk from the use of glyphosate
on alfalfa.
56
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GLYPHOSATE RED
September 1993
IV. RISK MANAGEMENT AND REREGISTRATION DECISION

A. Determination of Eligibility

Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after
submission of relevant data concerning an active ingredient, whether
products containing the active ingredients are eligible for reregistration. The
Agency has previously identified and required the submission of the generic
(i.e. active ingredient specific) data required to support reregistration of
products containing glyphosate active ingredients. The Agency has
completed its review of these generic data, and has determined that the
data are sufficient to support reregistration of all products containing the
isopropylamine and sodium salts of glyphosate. Appendix B identifies the
generic data requirements that the Agency reviewed as part of its
determination of reregistration eligibility of glyphosate, and lists the
submitted studies that the Agency found acceptable.

The data identified in Appendix B were sufficient to allow the Agency
to assess the registered uses of glyphosate and to determine that glyphosate
can be used without resulting in unreasonable adverse effects to man and
the environment. The Agency therefore finds that all products containing
glyphosate as the active ingredients are eligible for reregistration. The
reregistration of particular products is addressed in Section V of this
document.

The Agency made its reregistration eligibility determination based
upon the target data base required for reregistration, the current guidelines
for conducting acceptable studies to generate such data and the data
identified in Appendix B. : Although the Agency has found that all uses of
glyphosate (isopropylamine and sodium salt formulations) are eligible for
reregistration, it should be understood that the Agency may take appropriate
regulatory action, and/or require the submission of additional data to support
the registration of products containing glyphosate, if new information comes
to the Agency's attention or if the data requirements for registration (or the
guidelines for generating such data) change.

1. Eligibility Decision

Based on the reviews of the generic data for the active
ingredient glyphosate, the Agency has sufficient information on the
health effects of glyphosate and on its potential for causing adverse
effects in fish and wildlife and the environment. The Agency
57
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GLYPUOSATB RED
September 1993
concludes that products containing glyphosate for all uses are eligible
for reregistration.

The Agency has determined that glyphosate products, labeled
and used as specified in this Reregistration Eligibility Document, will
not pose unreasonable risks or adverse effects to humans or the
environment.

2. Eligible and Ineligible Uses

The Agency has determined that all uses of glyphosate are
eligible for reregistration.

B. Regulatory Position

The following is a summary of the regulatory positions and rationales
for glyphosate. Where labeling revisions are imposed, specific language is
set forth in Section V of this document.

1. Tolerance Re-assessment

The Agency has determined that aminomethyl phosphonic acid
(AMPA), the metabolite of glyphosate, no longer needs to be
regulated and therefore this compound will be dropped from the
tolerance expression. Also, although the monoammonium salt of
glyphosate is not subject to reregistration, the available data are to
allow re-assessment of existing tolerances for residues resulting from
the application of the monoammonium salt of glyphosate.

Tolerances Listed Under 40 CFR §180.364(a):

The tolerances listed in 40 CFR §180.364(a) are for the
combined residues of glyphosate and its metabolite AMPA resulting
from application of the isopropylamine salt of glyphosate and/or the
monoammonium salt of glyphosate.

Sufficient data are available to ascertain the adequacy of the
established tolerances listed in 40 CFR §180.364(a) for: acerola;
alfalfa, forage, seed, and hay; almonds, hulls; artichokes, Jerusalem;
asparagus; atemoya; avocados; Bahiagrass; bananas; beets, garden,
roots; Bermudagrass; bluegrass; Brassica leafy vegetables group;
bromegrass; bulb vegetables group; carambola; carrots; cereal grains
58
-------
CLYPHOSATS RED
September 1993
group; citrus fruits group; coffee beans, green; clover; cotton forage;
cotton hay; cottonseed; cranberries; cucurbit vegetables group;
fescue; figs; foliage of legume vegetables group; fruiting vegetables
group; grapes; grass forage, fodder, and hay group; guavas;
horseradish; kiwifruit; leafy vegetables group; leaves of the root and
tuber vegetables group; legume vegetables group; longan fruit;
lychee; mangoes; non-grass animal feeds group, forage and hay;
orchardgrass; papayas; parsnips; passion fruit; peanuts; peanuts,
vines; pineapple; pistachio; pome fruits group; radishes; rutabagas;
ryegrass; sapodilla; sapote; small fruits and berries group; soybeans;
soybean, forage; stone fruits group; sugar apple; sugar beets; sweet
potatoes; timothy; tree nuts group; turnip roots; wheatgrass; and
yams. Certain commodity definitions of the above tolerances are not
in accordance with the definitions listed in Table II of Subdivision O;
see the tolerance re-assessment table on page 63 for modifications
in commodity definitions.

The established crop group tolerances for the now-obsolete
"seed and pod vegetables" (0.2 ppm) and "seed and pod vegetables,
forage and hay" (0.2 ppm) are inappropriate and are to be replaced
with "legume vegetables, group (except soybeans)" and "legume
vegetables group, foliage of (except soybean forage and hay),"
respectively. Soybeans must be excluded from the crop group
tolerances because the use pattern for soybeans is different from
other legume vegetables, and the established tolerance for soybeans
and soybean forage and hay differ by a factor > 5x from other legume
vegetables. To achieve compatibility with Codex MRLs for selected
commodities, the following actions must be taken (see the table on
page 68): (i) increase U.S. tolerance for legume vegetables group
(except soybeans) from 0.2 ppm to 5 ppm; and (ii) increase U.S.
tolerance for soybean hay from 15 ppm to 20 ppm.

The.individual tolerances for cranberries (0.2 ppm) and grapes
(0.2 ppm) should be revoked since these fruits are covered by the
crop group tolerance (0.2 ppm) for small fruits and berries. The
tolerance for cotton hay is to be revoked since this is not a raw
agricultural commodity of cotton.
59
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GLYPHOSATB RED
September 1993
Tolerances for wheat, grain and wheat, straw at 4 and 85 ppm,
respectively, have been proposed (PPOF3865/FAP2H5635). When
these tolerances have been established, the tolerances for the cereal
grains group and the cereal grains group, forage, fodder, and straw
should be modified to "cereal grains group (except wheat)" and
"cereal grains group, forage, fodder, and straw (except wheat
straw)", respectively. To achieve compatibility with the Codex MRL
for wheat grain, the U.S. tolerance should be established at 5 ppm
(see the table on page 68).

The existing and conflicting tolerances for alfalfa (200 ppm),
alfalfa fresh and hay (0.2 ppm), clover (200 ppm), and forage
legumes (except soybeans and peanuts; 0.4 ppm) should be deleted.
Concomitant with the deletion of these tolerances, a tolerance of 100
ppm for residues in or on the non-grass animal feeds group, forage
and hay, is to be established. The available data from alfalfa,
lespedeza, and trefoil will support this crop group tolerance.

The established tolerances for "forage grasses" (0.2 ppm),
"grasses, forage" (0.2 ppm), Bahiagrass (200 ppm), Bermudagrass
(200 ppm), bluegrass (200 ppm), bromegrass (200 ppm), fescue (200
ppm), orchardgrass (200 ppm), ryegrass (200 ppm), timothy (200
ppm), and wheatgrass (200 ppm) is to be deleted. Concomitant with
the deletion of these tolerances, a tolerance for residues in on or on
the grass forage, fodder, and hay group is to be established at 100
ppm. The available data indicate that following registered use,
residues in or on the grass forage, fodder, and hay group will not
exceed 100 ppm.

Individual tolerances exist for residues in or on salsify and the
following tropical/subtropical crops: breadfruit; canistel; cherimoya;
cocoa beans; coconut; dates; genip; jaboticaba; jackfruit;
persimmons; sapote (black and white); soursop; and tamarind. There
are currently no registered uses of glyphosate on these crop sites.
These tolerances will be revoked.

A tolerance of 200 ppm has recently been established for
residues in or on soybean straw (FR 42701, 9/16/92). However, this
tolerance is to be revoked since this is not a raw agricultural
commodity of soybeans. The tolerance for soybeans, hay should be
raised to cover this desiccant use.
60
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GLYPHOSATE RED
September 1993
The expression negligible residues (N) should be deleted. For
a complete listing of appropriate commodity definition changes and
recommendations, see the table on page 63.

Tolerances Listed Under 40 CFR §180.364(b):

The tolerances listed in 40 CFR §180.364(b) are for the
combined residues of glyphosate and its metabolite AMPA resulting
from application of the glyphosate isopropylamine salt and/or
glyphosate monoammonium salt for herbicidal and plant growth
regulator purposes and/or the sodium sesqui salt for plant regulator
purposes.

Sufficient data are available to ascertain the adequacy of the
established tolerances listed in 40 CFR §180.364(b) for: liver and
kidney of cattle, goats, hogs, horses, poultry, and sheep; peanuts;
peanuts, hay; peanuts, hulls; sugarcane; fish; and shellfish. See the
table on page 63 for modifications in commodity definitions.

Tolerances Listed Under 40 CFR §180.364{c):

The tolerances listed in 40 CFR §180.364(c) are for the
combined residues of glyphosate and its metabolite AMPA resulting
from the use of irrigation water containing residues of 0.5 ppm
following applications on or around aquatic sites, and are established
at 0.1 ppm. The Agency's Office of Water has established a
maximum contaminant level (MCL) of 0.7 ppm for glyphosate perse
in drinking water {FR Notice: Vol. 57, No. 138, page 31776, dated
July 17, 1992).

Sufficient data are available to ascertain the established
tolerances listed in 40 CFR §180.364(c) for the crop groupings
Brassica leafy vegetables group; bulb vegetables group; cereal grains
group; citrus fruits group; cucurbit vegetables group; foliage of
legume vegetables group; forage, fodder, and straw of the cereal
grains group; fruiting vegetables group; grass forage, fodder and hay
group; leafy vegetables group; leaves of the root and tuber vegetables
group; legume vegetables group; non-grass animal feeds group,
forage and hay; pome fruits group; root and tuber vegetables group;
stone fruits group; tree nuts group; and the individual commodities
avocados, cottonseed, and hops. See the table on page 63 for
modifications in commodity definitions.
61
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GLYPHOSATB RED
September 1993
Tolerances Listed Under 40 CFR §185.3500:

The tolerances listed in 40 CFR §185.3500(1) are for the
combined residues of glyphosate and its metabolite AMPA resulting
from the application of the glyphosate for herbicidal purposes and/or
the sodium sesqui salt for plant.regulator purposes.

Sufficient data are available to ascertain the adequacy of the
established food additive tolerances listed in 40 CFR §185.3500(1)
for sugarcane, molasses. See the table on page 63 for modifications
in commodity definitions.

The tolerances listed in 40 CFR §185.3500(2) are for the
combined residues of glyphosate and its metabolite AMPA resulting
from the application of the isopropylamine salt of glyphosate for
herbicidal purposes.

Sufficient data are available to ascertain the adequacy of the
established food additive tolerances listed in 40 CFR §185.3500(2)
for olives (imported), palm oil, dried tea and instant tea. See the table
on page 63 for modifications in commodity definitions.

A 12-ppm food additive tolerance for wheat milling fractions
(except flour) has been proposed (FAP2H5635). To achieve
compatibility with the Codex MRL for wheat bran, unprocessed, the
U.S. tolerance should be established at 40 ppm (see the table on
page 68).

Tolerances Listed Under 40 CFR §186.3500:

The tolerances listed in 40 CFR §186.3500(a) are for the
combined residues of glyphosate and its metabolite AMPA.

Sufficient data are available to ascertain the adequacy of the
established feed additive tolerances listed in 40 CFR §186.3500(a)
for dried citrus pulp and soybean hulls. See the table on page 63 for
modifications in commodity definitions.

A tolerance has recently been established at 1.0 ppm for the
combined residues of glyphosate and AMPA in citrus, molasses (FR
42701,9/16/92).
62
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GLYPHOSATB RED
September 1993
Existing tolerances of glyphosate are currently established in
the Title 40 of the Code of Federal Regulations, §180.364. The
reassessment of the established tolerances is set forth in the
Tolerance Reassessment Table as follows.
Commodity
Current Tolerance '
(ppm)
Tolerance a
ReassMsirKsit (ppq»)
Tolerances listed under 180.364(a):
Acerola
Alfalfa
Alfalfa, fresh and hay
Clover
Forage legumes (except
soybeans and peanuts)
Almond hulls
Artichokes, Jerusalem
Asparagus
|| Atemoya
|] Avocados
j| Bahiagrass
Bermudagrass
Bluegrass
Bromegrass
Fescue
Forage grasses
I Grasses, forage
Orchardgrass
Ryegrass
Timothy
Wheatgrass
Bananas
Beets
Beets, sugar
(Breadfruit
Canistel

Cherimoya
Chicory
I' Citrus fruits
Cocoa beans
Coconut
0.2
200.0
0.2
200.0
0.4
1
0.2
0.5
0.2
0.2
200.0
200.0
200.0
200.0
200.0
0.2
0.2
200.0
200.0
200.0
200.0
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.1
•'•: '
Revoke and establish at
100

Revoke and establish at
100

Revoke
Revoke

Revoke

Revoke
Revoke
CoaaaKotfCorrect Commodity
Definition

Non-grass animal feeds
group, forage and hay
Almonds, hulls

Grass forage, fodder, and
hay group

Beets, garden, roots
Sugar beets
No registered uses
No registered uses

No registered uses
Chicory, roots
Citrus fruits group
No registered uses
No registered uses
63
-------
GLVPHOSATB RED
September 1993
Commodity
Coffee beans
Cotton,- forage
Cotton, hay
Cottonseed
Cranberries
DsteJ
Figs
Forage grasses
Grasses, forage
Fruits, small and berries
Genip
Grain crops
Grapes
Guavas
Horseradish
Jaboticaba
Jackfruit
Kiwi fruit
Leafy vegetables
Longan
Lychee
Mamy sapote
Mangoes
Nuts
Olives
Papayas
Parsnips
Passion fruit
Current Tolerance '
(ppra)
1
15
15
15
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.1
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.2
Tolerance 3
Reassessment (ppm)

Revoke

Revoke
Revoke

0.2

Revoke

Revoke
Revoke
0.1

Comment/Correct Commodity
;" r i Definition
Coffee beans, green

Not in Table n, Subdivision
0, PAG .

Covered under small fruits
and berries group
No registered uses

Forage, fodder, and straw of
cereal grains group
(except wheat straw)
Small fruits and berries
group
No registered uses
Cereal grains group (except
wheat)
Covered under small fruits
and berries group

No registered uses
No registered uses
see Codex Harmonization
Table
Leafy vegetables (except
Brassica) group
and
Leaves of root and tuber
vegetables group
Longan fruit

Sapote

Tree nuts group

Parsnips, roots

64
-------
GLYPHOSATE RED
September 1993
Commodity
Peanut, forage
Persimmons
Pineapple
Pistachio nuts
Pome fruits
Potatoes •
Radishes
Rutabagas
Salsify
Sapodilla
Sapote, black
Sapote, white
Seed and pod vegetables
Seed and pod vegetables,
forage
Seed aad pcd vegetables,
hay
Soursop
Soybeans
Soybeans, forage
Soybeans, hay
Soybeans, straw
Stone fruit
Sugar apple
Sweet potatoes
Tamarind
Turnips
Vegetables, bulb
Vegetables, cucurbit
Vegetables, fruiting (except
cucurbits) group
Vegetables, leafy, Brassica
(cole)
Yams
Current Tolerance '
(Pp«n)
0.5
0.2
0.1
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.2
20
15
15
200
0.2
0.2
0.2
0.2
0.2
0.2
0.5
0.1
0.2
0.2
Tolerance 2
Reassessment (pprn)

Revoke

Revoke
Revoke
5
0.2
Revoke

200
Revoke

Revoke
-

Comment/Cornier Commodity
Definition
Peanuts, vines
No registered uses
Pineapples
Pistachios
Pome fruits group

Radishes, root
Rutabagas, root
No registered uses

No registered uses
No registered uses
see Codex harmonization
Table;
Legume vegetables group
(except soybeans)
Foliage of legume
vegetables group (except
soybean forage and hay)
No registered uses

Raised to cover desiccant use.
Not in Table n, Subdivision
0, PAG
Stone fruits group

No registered uses
Turnips, roots
Bulb vegetables group
Cucurbit vegetables group
Fruiting vegetables group
Brassica leafy
vegetables group

6,5
-------
GLYfHOSATB RED
September 1993
Commodity
Wheat, grain
Wheat, straw
Current Tolerance '
(ppm)
N/A-
N/A
Tolerance *
Reassessment (ppm)
5.0
85 (proposed)
Comment/COTT«r Commodity
•'':"•• ., Definition *
see Codex harmonization
Table

Tolerances listed under 40 CFR S180.364(b):
Cattle, kidney
Cattle, liver
Fish
Goats, kidney
Goats, liver
Hogs, kidney
Hogs, liver
Horses, kidney
Horses, liver
Peanuts
Peanut, hay
Peanut, hulls
Poultry, kidney
Poultry, liver
Sheep, kidney
Sheep, liver
Shellfish
Sugarcane
0.5
0.5
0.25
0.5
0.5
0.5
0.5
0.5
0.5
0.1
0.5
0.5
0.5
0.5
0.5
0.5
3.0
2.0
2.0
2.0

1.0
1.0

see Codex harmonization
Table
see Codex harmonization '
Table

see Codex harmonization
Table
see Codex harmonization
Table

Peanuts, hay
Peanuts, hulls

Tolerances listed under 40 CFR 180.364(c):
Avocados
Citrus
Cottonseed
Cucurbits
Forage grasses
Forage legumes
Fruiting vegetables
0.1
0.1
0.1
0.1
0.1
0.1
0.1

Citrus fruits group

Cucurbit vegetables group
Grass forage, fodder, and
hay group
Non-grass animal feeds
group, forage and hay
Fruiting vegetables group
66
-------
GLYPHOSATE RED
September 1993
Commodity
Grain crops
Hops
Leafy vegetables
Nuts
Pome fruits
Root crop vegetables
Seed aad pod vegetables
Stone fruit
Current Tolerance '
. (K>m>
0.1
0.1
0.1
o.i
0.1 ,
0.1
O.i
0.1
. . Tolerance ^
Reassessment (ppm)

Comment/Correct Commodity
Definition
Cereal grains group
and
Forage, fodder, and straw of
cereal grains group

Leafy vegetables (except
Brassica) group
lad
Brassica (cole) leafy
vegetables group
Tree -nuts group
Pome, fruits group
Root and tuber vegetables
group
and
Leaves of root and tuber
vegetables group
and
Bulb vegetables group
Legume vegetables group
and
Foliage of legume
vegetables group
Stone fruits group
Tolerances listed under 40 CFR §185.3500(a)(l):
Molasses, sugarcane
30.0

Sugarcane, molasses
Tolerances listed under 40 CFR §185.3500(a)(2):
Oil, palm
Olives, imported
Tea, dried
Tea, instant
Wheat milling fractions
(except flour)
0.1
0.1
1.0
7.0
N/A

Revoke
40
Palm oil, refined

Not in Table H, Subdivision
O, PAG
see Codex harmonization
Table
Tolerances listed under 40 CFR §186.3500(a):
Citrus, pulp, dried
Citrus molasses
Soybean hulls
1.0
1.0
100

' ,
Citrus, molasses
Soybeans, hulls
67
-------
1 Tolerances are for the combined residues of glyphosate and its metabolite AMPA.
2 Tolerances are now for glyphosate per se.

CODEX HARMONIZATION TABLE

Several maximum residue limits (MRLs) for glyphosate have been
established by Codex in various commodities. The Codex MRLs
(currently expressed in terms of glyphosate per se) and applicable
U.S. tolerances (expressed in terms of the combined residues of
glyphosate and its metabolite AMPA) are listed in the table below.
The Agency has determined that AMPA no longer needs to be
regulated and therefore will be deleted from the tolerance expression.
Based on this determination, the expression of the U.S. tolerances
and the Codex MRLs will be harmonized, and both will now be
expressed in terms of glyphosate per se.

Codex MRLs and applicable U.S. tolerances. Recommendations for
compatibility are based on conclusions following reassessments of
U.S. tolerances (see Tolerance Reassessment Table, above).
Commodity . ;
Barley
Bi*J* (dry)
Cattle tucit
Cattle milk
C*ule, edible off*!
Cottonseed
Eggs
Hay or fodder (dry) of grasses
Kiwifiratt
Maize
OaU
Peat (dry)
Pig meat
Pig, edible offal
Poultry meat
Rape seed
Rice
Sorghum
Soy* bean fodder
Soya bean forage (green)
Soya bean (dry)
Soya bean (immature aeeds)
... MRL(Step>
:(mg/kg)
20 (CXL)
2 (CXL)
0.1(CXL)
0.1(CXL)
2 (CXL)
0.5(CXL)
O.HCXL)
50 (CXL)
0.1(CXL)
0.1(CXL)
20 (CXL)
5 (CXL)
0.1(CXL)
1 (CXL)
0.1(CXL)
10 (CXL)
0.1(CXL)
0.1(CXL)
20 (Step 8)
5 (Step 8)
5 (Step 8)
0.2(CXL)
U.&. Totorance: RecommendatioB ,
(ppm)
0.1 (Cereal grains group, except wheat)
0.2 (Legume vegetable* group, except
soybeans)

0.5 (Cattle, liver & kidney) increase U.S. tolerances
15

100 (Grata forage, fodder, and hay
group)
0.2 decrease U.S. tolerance
0.1
0.1 (Cereal grains group, except wheat)
0.2 (Legume vegetables group, except increase U.S. tolerance
soybeans)

0.5 (Hogs, liver & kidney) increase U.S. tolerances

0.1 (Cereal grains group, except wheat)
0.1 (Cereal grains group, except wheat)
15 (Soybeans, hay)
15 (Soybeans, forage)
20 (Soybeans)

68
-------
j Commodity

Straw and fodder (dry) of cere*] grains

Sweet corn (cora-on-the-cob)

Wheat

Wheat bnn, unproceiaed

Wheat flour

Wheat whole meal
MRL (Step) , U.S. Tolerance
(nag/kg) (ppm)
100 (CXI,) 0.2 (Forage, fodder, and ctnw of cereal
grain* group, except wheat «r»w)

0.1(CXL) 0.1 (Cereal grain* group, except wheat)

5 (CXI.) 4 (proposed)

40 (Step 6) 12 (proposed)

O.S(StepS)

5 (Step 8) 12 (propoted)
Recommendirioq
increaae U.S. tolerance propoul
increaae U.S. tolerance propoaal
The following conclusions can be made regarding efforts to harmonize the
U.S. tolerances with the Codex MRLs:

• Compatibility between the U.S. tolerances and permanent Codex
MRLs exists in or on: corn (field and sweet); rice; and sorghum.

• The levels of U.S. tolerances should be increased, toxicological and
ORES considerations permitting, to achieve compatibility with the
Codex MRLs in or on the following commodities: (i) liver and kidney
of cattle (from 0.5 to 2.0 ppm); (ii) liver and kidney of hogs (from
0.5 to 1.0 ppm); and (iii} legume vegetables group (except
soybeans) (from 0.2 to 5 ppm);

$ The level of the U.S. tolerance should be decreased to achieve
compatibility with the Codex MRLs in or on kiwifruit (from 0.2 to
0.1 ppm).

* The U.S. tolerances in or on the following commodities were based
on registered use patterns in the U.S. and cannot be lowered to
achieve compatibility with the Codex MRLs: (i) grass forage, fodder,
and hay group; (ii) soybeans; and (iii) soybeans, forage.

• Wheat grain and wheat bran tolerances of 4 and 12 ppm,
respectively, have been proposed. To achieve compatibility with
Codex, these tolerance levels should be increased, toxicological and
ORES considerations permitting, to 5 and 40 ppm, respectively.

• Wide differences (>5x) exist between the U.S. tolerances and
permanent Codex MRLs in or on the following commodities: barley;
beans (dry); soybeans, hay; cottonseed; oats; forage, fodder, and
straw of cereal grains. The decision to harmonize residue levels in
or on these commodities cannot be made at this time.

• No questions of compatibility exist with respect to commodities
where: (i) no Codex MRLs have been established, but U.S.
69
-------
tolerances exist; and (ii) Codex MRLs have been established, but
U.S. tolerances do not exist.

2. Labeling Rationale

While studies show that gfyjihosate««f» mo*e ihan^ligfetly 4&xk: is^jkds
and is practically non-toxic to fish and honeybees, a toxic inert in glyphosate
end use products necessitates the labelling of some products "toxic to fish"
since some glyphosate products are applied directly to aquatic environments.

3. Endangered Species Statement

Tha Agency does have concerns regarding exposure of endangered plant
species to glyphosate. In the June 1986 Registration Standard, the Agency
discussed consultations with the US Fish and Wildlife Service (FWS) on
hazards to crops, rangeland, silvicultural sites, and the Houston toad which
may result from the use of glyphosate. Because a jeopardy opinion resulted
from these consultations, the agency imposed endangered species labeling
requirements in the Registration Standard to mitigate the risk to endangered
species. Since that time, additional plant species have been added to the list
of endangered species, At the present time, EPA is working with the FWS and
other federal and state agencies to develop a program to avoid jeopardizing the
continued existence of all listed species by the use of pesticides. When the
Endangered Species Protection Program is implemented and subsequent
guidance is given, endangered species labeling amendments may be required
on affected end-use products. Labeling statements for end use products will
likely refer users to county specific bulletins specifying detailed limitations on
use to protect endangered species.

V. ACTIONS REQUIRED BY REGISTRANTS

This section specifies the data requirements and responses necessary for the
reregistration of both manufacturing-use and end-use products.

A. Manufacturing-Use Products

1. Additional Generic Data Requirements

The generic data base supporting the reregistration of glyphosate for the
above eligible uses has been reviewed and determined to be substantially
complete. The Agency will be calling in data on processed potatoes in a
separate DCI. However, the following additional generic data are required at
this time. These additional generic data are not part of the target data base for
70
-------
glyphosate and do not affect the reregistration eligibility of glyphosate. (See
Appendices for the Generic Data Call-In Notice.)
Name of Study
Tier n Vegetative Vigor
Droplet Size Spectrum
Drift Field Evaluation
Guideline Number
123-1
201-1
202-1
2. Labeling Requirements for Manufacturing-Use Products

Effluent Discharge Labeling Statement

Ail manufacturing-use or end-use products that may be contained in an effluent
discharged to the waters of the United States or municipal sewer systems must bear
the following revised effluent discharge labeling statement.

"Do not discharge effluent containing this product into lakes, streams, ponds,
estuaries, oceans or other waters unless in accordance with the requirements of a
National Pollutant Discharge Elimination System (NPDES) permit and the permitting
authority has been notified In writing prior to discharge. Do not discharge effluent
containing this product to sewer systems without previously notifying the local
sewage treatment plant authority. For guidance contact your State Water Board or
Regional Office of the EPA."

All affected products distributed or sold by registrants and distributors
(supplemental registrants) must bear the above labeling by October 1, 1995. All
products distributed or sold by persons other than registrants or supplemental
registrants after October 1,1997 must bear the correct labeling. Refer to PR Notice
93-10 or 40 CFR 152.46(a){1) for additional information.

B. End-Use Products

1. Additional Product-Specific Data Requirements

Section 4{g)(2)B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility
has been made. The product specific data requirements are listed in Appendix
G, the Product Specific Data Call-in Notice.

Registrants must review previous data submissions to ensure that they
meet current EPA acceptance criteria (Appendix F; Attachment'E) and if not,
71
-------
commit to conduct new studies. If a registrant believes that previously
submitted data meet current testing standards, then study MRID numbers
should be cited according to the instructions in the Requirement Status and
Registrants Response Form provided for each product.

2. Labeling Requirements for End-Use Products

The labels and labeling of all products must comply with EPA's current
regulations and requirements as specified in 40 GFR §156.10 and other
applicable documents. Please follow the instructions in the Pesticide
Reregistration Handbook with respect to labels and labeling. Furthermore, the
following additional labeling must be present on glyphosate end-use product
labels.

a. Nonaquatic

"Do not apply directly to water, to areas where surface water is
present or to intertidal areas below the mean high water mark. Do not
contaminate water when disposing of equipment washwaters and
rinsate."

b. Aquatic

"Do not contaminate water when disposing of equipment
washwaters and rinsate. Treatment of aquatic weeds can result in
oxygen loss from decomposition for dead plants. This loss can cause fish
kills."

c. Worker Protection Standard

Compliance

Any product whose labeling reasonably permits use in the
commercial or research production of an agricultural plant on any farm,
forest, nursery, or greenhouse must comply with the labeling
requirements of PR Notice 93-7, "Labeling Revisions Required by the
Worker Protection Standard (WPS), and PR Notice 93-11, "Supplemental
Guidance for PR Notice 93-7," which reflect the requirements of EPA s
labeling regulations for worker protection statements (40 CFR part 156,
subpart K). These labeling revisions are necessary to implement the
Worker Protection Standard for Agricultural Pesticides (40 CFR Part 170)
and must be completed in accordance with, and within the deadlines
specified in, PR Notices 93-7 and 93-11. Unless otherwise specifically
directed in this RED, all statements required by PR Notices 93-7 and 93-
72
-------
11 are to be on the product labeling exactly as instructed in those
notices.

After April 21, 1994, except as otherwise provided in PR Notices
93-7 and 93-11, all products within the scope of those notices must bear
WPS PR-Notice-complying labeling when they are distributed or sofd by
the primary registrant or any supplementally registered distributor.

After October 23,1995, except as otherwise provided in PR Notices
93-7 and 93-11, all products within the scope of those notices must bear
WPS PR-Notice-complying labeling when they are distributed or sold by
any person.

Personal Protective Equipment

Do not add any additional personal protective equipment
requirements to the labels of glyphosate end-use products, however,
any existing personal protective equipment on those labels must be
retained.

Entry Restrictions

Products not Primarily Intended for Home Use

Uses Within the Scope of the WPS: A 12-hour restricted entry interval
(RED is required for all uses within the scope of the WPS (see PR Notice
93-7) on all end-use products, except those intended primarily for home
use (see tests in PR Notice 93-7 and 93-11). This REI should be inserted
into the standardized REI statement required by PR Notice 93-7. The
personal protective equipment for early entry should be the PPE required
for applicators of glyphosate, except any applicator requirement for an
apron or respirator is waived. This PPE should be inserted into the
standardized early entry PPE statement required by PR Notice 93-7."

Sole-active-ingredient end-use products that contain glyphosate must be
revised to adopt the entry restrictions set forth in this section. Any
conflicting entry restrictions on their current labeling must be removed,

Multiple-active-ingredient end-use products that contain glyphosate must
compare the entry restrictions set forth in this section to the entry
restrictions on their current labeling and retain the more protective. A
specific time-period in hours or days is considered more protective than
"sprays have dried" or "dusts have settled."
73
-------
Uses Not Within the Scope of the WPS: Do not add any additional entry
restrictions for uses not within the scope of the WPS, however, any entry
restrictions on the current product labeling for those uses must be
retained.

"Products •Primarfly intended TOT tkmre -Us«i -r©f products -prifneffly
intended for home use (see tests in PR Notice 93-7 and 93-11), do not
add any additional entry restrictions for such products, however, any
entry restrictions on the current product labeling must be retained.

C. Existing Stocks

Registrants may generally distribute and sell products bearing old
labels/labeling for 26 months from the date of the issuance of this RED.
Persons other than the registrant may generally distribute or sell such products
for 50 months .from the date of the issuance of this RED. However, existing
stocks time frames will be established case-by-case, depending on the number
of products involved, the number of label changes, and other factors. Refer
to "Existing Stocks of Pesticide Products; State of Policy"; Federal Register,
Volume 56, No. 123, June 26, 1991.

The Agency has determined that registrants may distribute and sell
glyphosats products bearing old labels/labeling for 26 months from the date of
Issuance of this RED. Persons other than registrants may distribute or sell such
products for 50 months from the date of issuance of this RED.

VI. APPENDICES
74
-------
Appendix A

Use Patterns Subject to Reregistration
Appendix A is approximately 200 pages long and is not being
included in the mailing of the RED. Instead, a summary of
eligible sites and use groups is provided. Interested parties
may order a copy of the full Appendix A per the instructions in
Appendix D.
-------
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Appendix B

Table of Generic Data Requirements and
Studies Used to Make the Reregistration Decision
-------
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support
the reregistration for the pesticide glyphosate covered by this
Reregistration Eligibility Document. It contains generic data
requirements that apply to --jlyphosate in all products, including
data requirements for which a "typical formulation" is the test
substance.

The data table is organized in the following format:

1. Data Retirement (Column 1). The data requirements are
listed in the order in wnlch they appear in 40 CFR,
Part 158. The reference numbers accompanying each test
refer to the test protocols set in the Pesticide
Assessment Guidelines, which.are available from the
National Technical Information Service, 5285 Port Royal
Road, Springfield, VA 22161 (703) 487 - 4650.

2. Use Pattern (Column 2). .This column indicates the use
patterns for which the data requirements apply. The
following letter designations are used for the given
use patternss

A Terrestrial food
,B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential

3. Bibliographic citation (Column 3). 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 appendix for a complete
citation of the study.
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Appendix C

Citations Considered to be Part of the Data Base
Supporting the Registration of Glyphosate
-------
-------
GUIDE TO APPENDIX C
CONTENTS OP BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Reregistration Eligibility Document. 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 published literature, in those instances where
they have been considered, are included.

(JHSTS 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 also attempted to unite basic documents and
commentaries upon them, treating them as a single study.

IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by Master Record Identifier, or
"MRID Number", This number is unique to the citation, and
should be uses whenever a specific reference is required.
It is not related to the six-digit "Accession Number" which
has been used to identify volumes of submitted studies (see
paragraph 4(d)(4) below for further explanation). In a few
cases, entries added to the bibliography late in the review
may be preceded by a nine character temporary identifying
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
standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.

a. Author. Whenever the author could confidently be
identified, the Agency has chosen to show a personal
author. When no individual was identified, the Agency
has shown a identifiable laboratory or testing facility

C-1
-------
as the author. When no author or laboratory could be
identified, the Agency has shown the first submitter as
the author.

Document Date. The date of the study is taken directly
from the document. When the date is followed by a
question mark, the bibliographer has deduced the date
from the evidence contained in the document. When the
date appears as (19??), the Agency was unable to
determine or estimate the date of the document.

Title. In some cases, it has been necessary for the
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.

Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the
following elements describing the earliest known
submission:
(1)
(2)
Submission Date. The date of the earliest known
submission appears immediately following the word
"received"»

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.
When authorship is de-faulted to the submitter,
this element is omitted.
/
(4) volumfe Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL", which stands for "Company Data
Library". This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
C-2
-------
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. ABR79029. Summary of studies
237821-B through 237821-Q. (Unpublished 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 4 Lorox SOW: AG-A No. 4763 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 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
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 E.I. du
Pont de Nemours & Co., Inc. and ADC Laboratories, submitted
by Ciba-Geigy Corp., Greensboro, N,C,: CDL:237821-C)

00015763 Searcy, V.; Herman, D. (1979) Metolachlor + Glyphosate +
Linuron; Dual 8E + Roundup 4E + Lorox SOW: AG-A No. 4893
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 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 4- Glyphosate +
Linuron; Dual 8E + Roundup 4E + Lorox SOW: AG-A No. 4956
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 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 SOW): AG-A No. 4765 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-F)
C-3
-------
00015765 Schnappinger, M.G. (1978) Metolachlor (Dual 8E); Glyphosate
(Roundup 4E); Metribuzin (Sencor SOW): AG-A No. 4887 I,II.
(Unpublished 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., Greensboro, N.C.; CDL:237821-G)

00015766 Searcy, S.; Herman, D. (1979) Metolachlor (Dual 8E);
Glyphosate (Roundup 4E); Metribuzin (Sencor SOW): 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 3.00583? 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 SOW): 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 100583; prepared in cooperation with ADC
Laboratories and E.I. du Pont de Nemours & Co., Inc.,
submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:237821-1)

0002333ft Monsanto Company (1974) Residues of Glyphosate, Atrazine and
Simazine in or on Field Corn Grain, Sweet Corn and Corn
Forage and Fodder following a Tank Mix, Pre-emergent,
Minimum Till Application of Roundup, Atrazine and Simazine.
(Unpublished study received 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 Chemical 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-Phosphonomethylglycine (Glyphosate) and
Aminomethylphosphonic acid in Sugarcane, Bagasse, Raw Sugar
and Molasses. (Unpublished study received Dec 28, 1979 under
524-332; CDL:099157-B)
C-4
-------
00028852
00028853
00033954
00036222
00036223
00036229
00036231
00036328
00037687
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)

Monsanto Company (19??) Analytical Residue Method for
N-(Phosphonomethyl) glycine, Aminomethylphosphonic acid and
N-Nitroso-N(phosphonomethyl) glycine in Peanuts.
(Unpublished study received Feb 22, 1980 under 524-308;
CDL:099306-B)

Monsanto Company (1973) Summary and Conclusion: Residue
Data. (Unpublished study received Dec 30, 1975 under
524-308; CDL: 224062-A)

Monsanto Company (1974) Analytical Residue Method for
N-Phosphonomethyl 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)

Monsanto Company (1974) Analytical Residue Method for
N-Phosphonomethyl 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)
00037688
Kramer, R.M, ', Beasley, R.K.; Steinmetg* J.R.; et al, (1975)
Interim Report on CP 67573, Residue and Metabolism, Part 28:
Determination of Residues of Glyphosate and Its Metabolite
in Fish: Agricultural Research Report No. 378. (pp. 1-13
only; unpublished study received Sep 25, 1975 under 6G1679;
submitted by Monsanto Co., Washington, D.C.; CDL:095356-1)

Monsanto Company (1975) Analytical Residue Method for
N-Phosphonomethylglycine and Aminomethylphosphonic acid in
Fish Tissue. Method dated Sep 2, 1975. (Unpublished study
received Sep 25, 1975 under 6G1679; CDL:095356-K)

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)

Monsanto Company (1976) Residues of Glyphosate, Alachlor and
Cyanazine in or on Field Corn Forage, Fodder, and Grain
following a Tank Mix, Pre-emergent, Minimum Till Application
of Roundup, Lasso and Blades. (Unpublished study received
Apr 18, 1979 under 524-285; CDL:238167-B)

Monsanto Company (1979) Analytical Residue Method for
N-Phosphonomethyl Glycine, Aminomethylphosphonic acid and
C-5
-------
N-Nitrosoglyphosate 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 Report on CP 67563, Residue and Metabolism: Part 21:
Determination of CP 67573 and CP 50435 Residues in Grapes:
Agricultural Research Report No. 337. Includes undated
method entitled: Roundup and metabolite residue analytical
method. (Unpublished study received Oct 4, 1974 under
5fl560; 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:095787-8)

00038979 Cowell, J.E.; Taylor, A.L.; Stranz, J.L.; et al. (1974)
Roundup and Metabolite Residue Analytical Method.
(Unpublished study received 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)
Summary of Metabolism Studies of Glyphosate in Citrus
Plants. (Unpublished 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) Summary 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)

00039381 Kramer, R.M.; Arras, D.D.; Beasley, R.K.; et al. (1975)
C-6
-------
Final Report 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.
(Unpublished study received Aug 13, 1975 under 5F1536;
CDLJ094866-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-Phosphonomethyl glycine and Aminomethylphosphonic acid in
Forage and Grain. Method dated Mar 1, 1974. (Unpublished
study received on unknown date under SG1523; 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)

00046363 Rodwell, D.E.; Tasker, E.J.; Blair, M..; 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
C-7
-------
00048284
00051980
00051982
00051983
00053005
00059050
00060103
00061555
00061559
Monsanto Co., Washington, D.C.; CDL:242516-B)

Monsanto Company (1973) Residue Data. (Compilation;
unpublished study received on unknown date under 524-EX-21;
CDL:223373-E)

Monsanto Company (1975) Residue Results. (Unpublished study
received Jun 3, 1976 under 524-308; CDL:096177-D)

Monsanto Company (1976) Analytical Residue,Method for
N-Phosphonomethylglycine and Aminomethylphosphonic acid in
Green Coffee Beans. Method dated May 1, 1976. (Unpublished
study received Jun 3, 1976 under 524-308; CDL:096177-F)

Malik, J.ML; Curtis, T.S.; Marvel, J,T. (1975) Final Report
on CP67573, Residue and Metabolism? Part 24s The Metabolism
of CP67573 in Coffee Plants: Agricultural Research Report
No. 344. (Unpublished study received Jun 3, 1976 under
524-308; submitted by Monsanto Co.xx Washington, D.C.;
CDL:096177-1)

Beasley, R.K.; Steinmetz, J.R.; Taylor, A.L.; et al. (1977)
Analytical Residue Method for N-Phosphonomethyl glycine and
Aminomethylphosphonic 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.; CDLJ099625-B)

Interregional Research Project Number 4 (1978) Summary of
Glyphosate Residues in Guaya. (Unpublished study received
Nov 19, 1980 under 1E2443; CDL:099739-A)

Baszis, S.R.; Cowell, 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-(Phosphonomethyl)glycine in forages and grains.
(Unpublished study received Nov 12, 1980 under 524-EX-54;
submitted by Monsanto Co., Washington, D.C.; CDL:099720-A)

Monsanto Company (1974) Residue Results. (Unpublished study
received on unknown date under 524-EX-24; CDL:095345-J)

Monsanto Company (19??) Analytical Residue Method for
N-Phosphonomethyl glycine (Glyphosate) and
Aminomethylphosphonic acid in Sugarcane, Sugarcane Leaves,
Bagasse, Sugar and Molasses, Irrigation Water and Soil.
(Unpublished study received Mar 11, 1976 under 524-308;
CDL:095141-E)
C-8
-------
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-Phosphonomethylglycine and Aminomethylphosphonic acid in
Papaya: Project No. 5064. (Unpublished study received Nov
20, 1980 under 524308; CDL:099751-B)

00065751 Monsanto Company (1966?) Analytical Residue Method for
N-(Phosphonomethyl)-glycine, Aminomethylphosphonic Acid and
N-Nitroso-N(phosphonomethyl)-glycine in Forages, Grains,
Soil and Water. Undated method 1. (Unpublished study
received May 12, 1977 under 524-308; CDL:229787-C)

00065752 Monsanto Company (1966?) Analytical Residue Method for
N-(PhosphonoKnsthyl)-glycine, Aminomethylphosphonic Acid and
N-Nitroso-N{phosphonomethyl)-glycine in Forages, Grains and
Water. Undated method 2. (Unpublished study received May 12,
1977 under 524308; CDL:229787-D)

00065753 Frazier, H.W.; Rueppel, M.L. (1976) Crop Metabolism Studies
of N(Phosphonomethyl)-glycines N-Nitrosoglyphosate: Report
No. 477. Interim rept, (Unpublished study received May 12,
1977 under 524-308; submitted by Monsanto Co., Washington,
D.C.-J CDLl 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; 2t3991)

00070893 LeBlanc, G.A.; Surprenant, D.C.; Sleight, 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
C-9
-------
00070895
00070897
00076491
00076492
00076805
00077227
00077228
00077229
Monsanto Co., Washington, D.C.; CDL:244749-B)

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)

LeBlanc, G.A.; Surprenant, D.C.; Sleight, B.H., III (1980)
Acute Toxicity of Roundup to Bluegill (Lepomis macrochirus)
Report IBW-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)

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)

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)

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., Washington, D.C.; CDL:070083-A)

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)

Branch, O.K.; Stout, L.D.; Folk, R.M. (1981) Primary Eye
Irritation 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)

Branch, O.K.; Stout, L.D.; Folk, R.M. (1981) Primary Skin
Irritation of MON 2139 NF-80-W to Rabbits: EHL 800296.
(Unpublished study received Jul 1, 1981 under 524-308;
submitted by Monsanto Co., Washington, D.C.; CDL:07D170-I)
C-10
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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
Irritation 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, D,K,; Stout, L.D.; Folk, R.M. (1981) Primary Skin
Irritation of MON 2139 NF-80-AA to Rabbits: EHL 800292.
(Unpublished 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., Washington, 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 received Jul 1,, 1981 under 524-308; submitted by
Monsanto Co., Washington, D.C.; CDL:070170-0)

00077236 Branch, D.K,; Stout, L.D.; Folk, R.M. (1981) Primary Eye
Irritation 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
Irritation 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)

00077238 Dubelman, S.; Steinmetz, J.R. (1981) Glyphosate Residues in
Water following Application of Roundup Herbicide to Flowing
Bodies 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)
C-11
-------
00078619
00078620
00078655
00078656
00078657
00078658
00078659
00078660
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 Environmental Toxicology, Japan, submitted by
Monsanto Co., Washington, D.C.; CDL:238233-A)

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; submitted by Monsanto Co., Washington, D.C.;
CDL:238233-B)

Thompson, C.M.; Griffen, J.; Boudreau, P. (1980) Acute
Toxicity of MON 2139 NF-80W (AB-80-363) to Rainbow Trout
(Salmo gairdneri): 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)

Thompson, C.M.; Griffen, J.; (1980) Acute Toxicity of MON
2139 NF80W (AB-80-364) to Bluegill Sunfish (Lepomis
macrochirus): Static Acute Bioassay Report #26315.
(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-C)

ForMs, 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., submitted by Monsanto Co., Washington,
D,C.; CDL:070171-D)

Thompson, C.M.; Griffen, J.; Forbis, A.D. (1980) Acute
Toxicity of MON 2139 NF-80-AA (AB-80-367) to Rainbow Trout
(Salmo gairdneri): 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)

Thompson, C.M.; Griffen, J. (1980) Acute Toxicity of MON
2139-NF80-AA (AB-80-368) to Bluegill Sunfish (Lepomis
macrochirus): static Acute.Bioassay Report #26318.
(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-F)

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
C-12
-------
Laboratories, Inc., submitted by Monsanto Co., Washington,
D.C.; CDL: 070171^3)

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 received Jul 1, 1981 under 524-308?
prepared by Analytical Bio Chemistry Laboratories, Inc.,
submitted by Monsanto Co., Washington, 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 macrochirus) : Static Acute Bioassay Report #27.201.
(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
Bioassay Report #27203. ( 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-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 Laboratories, 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 received Jul 1, 1981 under 524-308;
prepared by Analytical Bio Chemistry Laboratories, Inc.,
submitted by Monsanto Co., Washington, D.C.; CDL:070171-L)

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., submitted 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
C-13
-------
00108129
00108132
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 received Jul 12, 1974 under
5F1536; submitted by Monsanto Co., St. Louis, MO;
CDL:094180-C)

Monsanto Co. (1976) Residue Studies and Methods of Analysis
for Use of Glyphosate in Pome Fruit Orchards. (Compilation;
unpublished study received Sep 7, 1976 under 524-308;
CDL:095269-C)

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)

Monsanto Co. (1976) Residue Studies in Green and Dry
Alfalfa: Metabolism Studies in Pasture Crops: Glyphosate.
(Compilation; unpublished study received Jan 11, 1977 under
524-308? CDL:C95704-A)

Monsanto Co. (1975) Glyphosate Residue and Metabolism
Studies in Sugarcane and Soils. (Compilation; unpublished
study received Jul l, 1976 under 6G1826; CDL:095972-B)

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:096821-A)

Monsanto Co. (1977) Residue and Metabolism: Roundup on
Forage Grasses, Legumes and Pasture Crops. (Unpublished
study received May 9, 1978 under 524-308; CDL:097094-B)

Cowell, J.; Jordan, L.; Kramer, R.; et al. (1976) Glyphosate
Residues in Avocados following Post-directed Treatments with
Roundup 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:
Roundup. (Compilation; unpublished study received Dec 22,
1977 under 524-EX-43; CDL:096684-A)
00108133
00108140
00108144
00108147
00108149
C-16
-
-------
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 Fathead 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 Glyphosate (AB-78-201) to Daphnia magna..
(Unpublished study received Dec 27, 1978 under 524-308;
prepared by Analytical Biochemistry Laboratories, Inc.,
submitted by Monsanto Co., Washington, DC; CDL:097759-C)

0010817S 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)

00108176 Monsanto Co. (1975) Residue Studies and Methods of Analysis
for Pre-emergent Use of Glyphosate in Cotton. (Compilation;
unpublished 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;
unpublished 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 0101s Report No. MSL-0207.
Final rept. (Unpublished study received Jun-12, 1978 under
C-17
-------
00108200
00108203
00108204
00108205
003/.8207
00108231
00109271
00111945
524-308; submitted by Monsanto Co., Washington, DC;
CDL:234108-A)

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; prepared by Industrial Bio-Test Laboratories, Inc.,
submitted by Monsanto Co., Washington, DC; CDL:234152-A)

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)

Fink, R.; Beavers, J.; Brown, R. (1978) Final Report: Acute
Oral LD50—Bobwhite Quail: Technical Glyphosate: Project No.
139140. (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)

McAllister, W.; Forbis, A. (1978) Acute Toxicity of
Technical Glyphosate to Bluegill Sunfish (Lepomis
macrochirua): Static Acute Bioassay Report. (Unpublished
study received Jul 14, 1978 under 524-308; prepared by
Analytical Bio Chemistry Laboratories, Inc., submitted by
Monsanto Co., Washington, DC; CDL: 234395-B)

Fink, R.; Beavers, J. (1978) Final Report: One-generation
Reproduction study—Bqbwhite 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)

Conkin, R.; Serdy, F.; Street, R. (1979) A Short Residue
Method for Glyphosate, Active Ingredient in Roundup
Herbicide: MSL0838. (Unpublished study received Jul 30, 1979
under 524-308; submitted by Monsanto Co., Washington, DC;
CDL:238888-A)

Monsanto Co. (19??) Crop Residues and Tolerances.
(Unpublished study received Apr 9, 1982 under KS 82/1 for
Monsanto; CDL:. 247348-B)

Monsanto Co. (1976) Residue and Plant Metabolism Studies.
(Compilation; unpublished study received Dec 8, 1976 under
524-308; CDL.-095633-A)
00111949 Danhaus, R.; Kramer, R. (1978) Glyphosate Residues in Stone
C-18
-------
Fruit following Postemergent Directed Treatments with
Roundup Herbicide: Report No. MSL-0454. Final rept.
(Unpublished study received 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
Reproduction 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, J0 (1982) Glyphosate Residues in
Wheat Grain following Ropewick Wiper Treatment with Roundup
Herbicides MSL-2569. (Unpublished study received Dec 17,
1982 under 524308; submitted by Monsanto Co., Washington,
DC; CDL:071296-A)

00124760 Forbis, A.; Boudreau, P.; Cranor, xx. (1982) Dynamic 96-hour
Acute Toxicity of Roundup (AB-82-33) to Bluegill Sunfish
(Lepomis macrochirus): Dynamic Acute Bioassay Report 128746.
(Unpublished 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
pseudolimnaeus: Dynamic Acute Bioassay Report #28747.
(Unpublished study received Dec 27, 1982 under 524-308;
prepared by Analytical Bio-Chemistry Laboratories, Inc.,
submitted by Monsanto Co., Washington, DC; CDL:249159-C)

00124763 McAllister, W.; McKee, M.; Schofield, M.; et al. (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., submitted by Monsanto Co., Washington,
DC; CDL:249160-A)

00130406 Knezevich, A.; Hogan, G. (1983) A Chronic Feeding Study of
Glyphosate (Roundup Technical) in Mice: Project No. 77-2061:
BDN-77420. Final rept. (Unpublished study received Aug 17,
1983 under 524-308; prepared by Bio/dynamics, Inc.,
submitted by Monsanto 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.
(Unpublished study received Nov 15, 1983 under 524-308;
submitted by Monsanto Co., Washington, DC; CDL:251737-B)
C-19
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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; submitted 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
Intraperitoneal Administration in the Rat: Study No. 830109.
(Unpublished study received Nov 15, 1983 under 524-308;
submitted by Monsanto Co., Washington, DC; CDL:251737-F)

00132686 Williams, Go; Tong, C.; Dirks, R.; et al. (1983) The
Hepatocyte Primary Culture/DNA Repair Assay on Compound
JJN-1020 Using Rat Hepatocytes in Culture: NDItln 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
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GS0178-003 Suba, L. (1976) Metabolism of CP67573 in Representative
Vegetables and Rotation Crops: Final Report No. 406.
Unpublished study prepared by Monsanto Agricultural
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GS0178-004 Brightwell, B, (1978) Bioaccumulation and Metabolism
of Glyphosate in Channel Catfish (Ictalurus punctatus: Final
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Agricultural Research Dept. 34 p.

GS017Q-014 Lauer, R.; Cowell, J.; Briggs, L.ret 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-nitnoso-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.
C-20
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GS017S-022 Zee, K. (1975) Memorandum to J. Cummings dated Nov 1,
1975s PP #5F1536. Method tryout for glyphosate on soybeans.
2 p.

GS0178-023 Zee, K. (1977) Memorandum to J. Cummings dated Feb 9,
1977: PP I6F1733 and 6F1758. Method tryout for glyphosate in
beef liver. 2 p.

GS0178-025 Folmar, L. °, Seinders, 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,

*3SQ178-028 Monsanto Co., (1976) Information to Support
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Palm Oil: Special Report No. 424. Vol 1 of 1, Sections A-J.
Unpublished study. 41 P.

Arkansas Cooperative Extension Service (1985) Recommended
Chemicals for Weed and Brush Control, MP-A4, Arkansas.

Hill, E.F., Heath, R.G., Spann, J.W. and Williams, J.D.(1975)
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Birds, U.S.F.W.S,, Special Scientific .Report—Wildlife No.
191.

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Kenaga (1973) Factors to be considered in the Evaluation of
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Leonard, W.H. and Martin, J.H. (1963) Cereal Crops. Part V.
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USDA, The biologic and economic assessment of 2,4,5-T,
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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,
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C-21
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40159301 Bohn, J. (1987) An Evaluation of the Preemergence Herbicidal
Activity of CP-70139: Lab Project ID: 056337. Unpublished
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40236901 Hughes, J. (1987) The Toxicity of Glyphosate Technical to
Selenastrum capricornutum: Lab Project ID: 1092-02-1100-1.
Unpublished study prepared by Malcolm Pirnie, Inc. 23 p.

40236902 Hughes, J. (1987) The Toxicity of Glyphosate Technical to
Navicula pelliculosa: Lab Project ID: 1092-02-1100-2.
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40236903 Hughes, J. (1987) The Toxicity of, Glyphosate Technical to
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40236904 Hughes, J. (1937) The Toxicity of Glyphosate Technical to
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40236905 Hughes, J. (1987) The Toxicity of Glyphosate Technical to
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study prepared by Malcolm Pirnie, Inc. 22 p.

41400603 Blaszcak, D. (1988) Eye Irritation Study in Rabbits for
Glyphosate Technical (Wetcake): Lab Project Number: 4888-88:
Monsanto Reference No. BD-88-114. Unpublished study
prepared by Bio/dynamics, Inc. 20 p.

41400604 Blaszcak, D. (1988) Primary Dermal Irritation Study in
Rabbits for Glyphosate Technical (Wetcake): Lab Project
Number: 4887-88: Monsanto Reference No. BD-88-114.
Unpublished study prepared by Bio/dynamics, Inc. 17 p.

ACCSN: 252142 A MRID: 00137137
B MRID: 00137138
C MRID: 00137139
D MRID: 00137140

00137137 Auletta, C.; Daly, I.; Blaszcak, D.; et al. (1983) A Dermal
Sensitization Study in Guinea Pigs: [Roundup Formulation]:
Bio/dynamics Project No. 4234-83; Monsanto Reference No. BD-
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308; prepared by Bio/dynamics, Inc., submitted by Monsanto
Co., Washington, DC; CDL:252142-A)

00137138 Auletta, C.; Daly, I.; Blaszcak, D.; et al. (1983) A Dermal
Sensitization Study in Guinea Pigs: [Glyphosate]:
Bio/dynamics Project No. 4235-82; Monsanto Reference No. BD-
83-008. (Unpublished study received Jan 5, 1984 under 524-
308; prepared by Bio/dynamics, Inc., submitted by Monsanto
C-22
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Co., Washington, DC; CDL: 252142-B)
00137139
00137140
40405401
41400601
41400602
41573601
40559401
00093879
00036803
Maibach, H. (1982) [Toxicity: 14C-glyphosate in Monkeys].
(Unpublished study received Jan 5, 1984 under 524-308;
prepared by Univ., of California—San Fransisco, School of
Medicine, submitted by Monsanto Co., Washington, DC;
CDL:252142-C)

Franz, T. (1983) Evaluation of the Percutaneous Absorption
of Roundup Formulations in Man Using an in vitro Technique:
Monsanto Study No. UW-81-346. Final rept. (Unpublished
study received Jan 5, 1984 under 524-308; prepared by Univ.
of Washington, School of Medicine, submitted by Monsanto
Co., Washington, DC; CDL:252142-D)

Hirsch, R.; Augustin, D. (1987) Nitrosamine Analyses of
Roundup Herbicide, rodeo Herbicide, MON 0139 and Polado
Technical: Laboratory Project ID R. D. No. 835.
Unpublished study prepared by Monsanto Agricultural Company.
212 p.

Blaszcak, D, (1988) Acute Oral Toxicity Study in Rats for
Glyphosate Technical (Wetcake) ...: Lab Project Number:
4885-88: Monsanto Reference No. BD-88-114. Unpublished
study prepared by Bio/dynamics, Inc. 18 p.

Blaszcak, D. (1988) Acute Dermal Toxicity Study in Rabbits
for Glyphosate Technical (Wetcake): Lab Project Number:
4886-88: Monsanto Reference No. BD-88-114. Unpublished
study prepared by Bio/dynamics, Inc. 17 p.

Herre, B.? Korndorfer, C.; Barclay, J. (1990) Product
Chemistry Data to Support the Registration of the 62%
Solution of the Isopropylamine Salt of Glyphosate (MON-
0139): Storage Stability Study: Lab Project Number: MSL-
6199: 1006. Unpublished study prepared by Monsanto
Agricultural Co. 12 p.

Stout, L.; Johnson, C. (1987) 90-day Study of Glyphosate
Administered in Feed to Sprague/Dawley Rats: Proj. ID ML-86-
351/EHL 86128. Unpublished study prepared by Monsanto
Agricultural Co. 267 p.

Lankas, G.R.; Hogan, G.K. (1981) A Lifetime Feeding Study of
Glyphosate (Roundup Technical) in Rats: Project No. 77-
2062. (Unpublished study received Jan 20, 1982 under 524-
308; prepared by Bio/dynamics, Inc., submitted by Monsanto
Co., Washington, D.C.; CDL:246617-A; 246618; 246619; 246620;
246621)

Street, R.W.; Conkin, R.A.; Edwards, G.A.; et al. (1980) A
C-23
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Three-Month Feeding Study of Glyphosate in Mice: Special
Report # MSL-1154. (Unpublished study received Jul 2, 1980
under 524-308; submitted by Monsanto Co., Washington, D.C.;
CDL:242799-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., submitted by Monsanto Co., Washington, D.C.;
CDL:247228-A)

00153374 Reyna, M, (1985) Twelve Month Study of Glyphosate
Administered by Gelatin Capsule to Beagle Dogs: Project No.
ML-83-137: Study No. 330116. Unpublished study prepared by
Monsanto Company Environmental Health. 317 p.

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 Jan 20, 1982 under 524-
308; prepared by Bio/dynamics, Inc., submitted by Monsanto
Co., Washington, D.C.; CDL:246617-A; 246618; 246619; 246620;
246621)

41643801 Stout, I..; Ruecker, F, (1990) Chronic Study of Glyphosate
Adminitered in Feed to Albino Rats: Lab Project Number: MSL-
10495: R.D. 1014. Unpublished study prepared by Monsanto
Agricultural Co. 2175 p.

00153374 Reyna, M. (1985) Twelve Month Study of Glyphosate
Administered by Gelatin Capsule to Beagle Dogs: Project No.
ML-83-137: Study No. 830116. Unpublished study prepared by
Monsanto Company Environmental Health. 317 p.

00130406 Knezevich, A.; Hogan, G. (1983) A Chronic Feeding Study of
Glyphosate (Roundup Technical) in Mice: Project No. 77-2061:
BDN-77-420. Final rept. (Unpublished study received Aug
17, 1983 under 524-308; prepared by Bio/dynamics, Inc.,
submitted by Monsanto Co., Washington, DC; CDL:251007-A;
251008; 251009; 251010; 251011; 251012; 251013; 251014)

00150564 McConnel, R. (1985) A Chronic Feeding Study of Glyphosate
(Roundup Technical in Mice): Pathology Report on Additional
Kidney Sections: Addendum to Final Report Dated July 21,
1983: Project No. 77-2061A. Unpublished study prepared by
Bio/dynamics Inc. 59 p.

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
C-24
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Development Corp.,, submitted by Monsanto Co., Washington,
D.C.; CDL:242516-A) •

00046363 Rodwell, D.E.; Tasker, E.J.; Blair, M.; 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) 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.
(Unpublished study received Jul 7, 1982 under 524-308;
submitted by Monsanto Co., Washington, DC; CDL:247793-A)

00105995 Street, R. (1982) Letter sent ot R. Taylor dated Jul 6,
1982: Roundup Herbicide: Addendum to pathology reprot for
a three-generation reproduction study in rates with
glyphosate. (Unpublished study received Jul 7, 1982 under
524-308; submitted by Monsanto Co., Washington, DC;
CDL:247793-A)

41621501 Jteyna, M. (1990) Two Generation Reproduction Feeding Study
with Glysophate in Sprague-Dawley Rats: Lab Project No: MSL-
10387. Unpublished study prepared by Monsanto Agricultural
Co. 1158 p.

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,* submitted by Monsanto Co., Washington, D.C.;
CDL:238233-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; submitted by Monsanto Co., Washington, DC;
CDL:251737-D)

00078619 Shirasu, Y.; Moriya, M.; Ohta, T. (1978) Microbial
Mutagenicity Testing on CP67573 (Glyphosate). (Unpublished
study received April 25, 1979 under 524-308; prepared by
Institute of Environmental Toxicology, Japan, submitted by
Monsanto Co., Washington, D.C.; CDL:238233-A)

40767101 Ridley, W.; Mirly, K. (1988) The Metabolism of Glyphosate in
Sprague Dawley Rats—Part I. Excretion and Tissue
C-25
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Distribution of Glyphosate and Its Metablites following
Intravenous and Oral Administration: Laboratory Project No.
86139 (MSL-7215): R.D. No. 877. Unpublished study prepared
by Monsanto Co. 587 p.

40767102 Howe, R.; Chott, R.; McClanahan, R. (1988) Metabolism of
Glyphosate in Sprague-Dawley Rats. Part II. Identification,
Characterization, and Quantitation of Glyphosate and Its
Metabolites after Intravenous and Oral Administration:
Laboratory Project No. MSL-7206: R.D. No. 877. Unpublished
study prepared by Monsanto Co. 155 p.

Study No.: UW-81-346; Date: 8/30/83; No MRID or Accession No.)

"Pesticides Contaminated with N-nitroso Compounds, proposed policy 45
PR 42854 (June 25, 1980)"

00152596 Thompson, C.; McAllister, W. (1983) Acute Toxicity of Liqua
Wet to Rainbow Trout (Salmo gairdneri): Report §30409.
Unpublished study prepared by Analytical Bio-Chemistry
Laboratories, Inc. 51 p.

00152599 Kinter, D.; Forbis, A. (1983) Acute Toxicity of LI-700 to
Rainbow Trout (Salmo gairdneri): Report No. 30412.
Unpublished study prepared by Analytical Bio-Chemistry
Laboratories, Inc. 46 p.

00152601 Thompson, C.; McAllister, W. (1983) Acute Toxicity of
Passage to Rainbow Trout (Salmo gairdneri): Report No.
30412. Unpublished study prepared by Analytical Bio-
Chemistry Laboratories, Inc. 46 p.

00152767 Kinter, D.; Forbis, A. (1983) Acute Toxicity of [Inert
Ingredient] to Rainbow Trout (Salmo gairdneri): Static
Bioassay Report No. 30415. Unpublished Monsanto Study No.
AB-83-120 prepared by Analytical Bio-Chemistry Laboratories,
Inc. 46 p.

00152597 Burgess, D.; Forbis, A. (1983) Acute Toxicity of Liqua-Wet
to Daphnia magna: Report No. 30410. Unpublished study
prepared by Analytical Bio-Chemistry Laboratories, Inc. 35
P-

00152600 Burgess, D.; Forbis, A. (1983) Acute Toxicity of LI-700 to
Daphnia magna: Report No. 30413. Unpublished study
C-26
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prepared by Analytical Bio-Chemistry Laboratories, Inc. 34
p. '

00152602 Burgess, D.; Forbis, A. (1983) Acute Toxicity of Passage to
Daphnia magna: Report No. 30413. Unpublished study
prepared by Analytical Bio-Chemistry Laboratories, Inc. 34
p.

00152768 Burgess, D.; Forbis, A. (1983) Acute Toxicity of [Inert
Ingredient] to Daphnia magna: Static Acute Bioassay Report
No. 30416. Unpublished Monsanto Study No. AB-83-122
prepared by Analytical Bio-Chemistry Laboratories, Inc. 36
P-

41335101 Shepler, K.; McGovern, P. (1989) Photodegradation of Carbon-
14 Glyphosate in/on Soil by Natural Sunlight: Lab Project
Number: MSL-9271: PTRL-153W. Unpublished study prepared
by Pharmacology and Toxicology Research Laboratory. 82 p.

42765001 Oppenhuizen, M. (1993) The Terrestrial Field Dissipation of
Glyphosate: Final Report: Lab Project Number: MSL-12651:
91-63-R-l: AL-91-121. Unpublished study prepared by The
Agricultural Group of the Monsanto Co. and Pan-Agricultural
Labs, Inc* 1244 p.

40559301 Barclay, J.? Pike, R. (1987) Product Chemistry Data to
Support the Registration of MON-8783 (FallowMaster)s
Storage Stability Study: Laboratory Project ID MSL-6537, R.
D. No. 819. Unpublished study prepared by Monsanto
Agricultural Company. 38 p.

00162912 Ruecker, F. (1986) Addendum to One-year Toxicology Study in
Dogs with Glyphosate: Special Report MSL-5927. Unpublished
addendum prepared by Monsanto Agricultural Co. 6 p.

00046364 Rodweli, D. E.; Wrenn, J. M.; Blair, A. M.; et al. (1980)
Dominant Lethal Study in Mice: IRDC No. 401-064.
(Unpublished study received May 23, 1980 under 524-308;
prepared by International Research and Development Corp.,
submitted by Monsanto Co., Washington, DC; CDL: 242516-C)

00161333 Hammon, J. (1986) Product Chemistry Data To Suppport the
Continued Registration of Glyphosphate
(N-phosphonomethylglycine): Report No. MSL-5066 (Revised):
Project No. 7663. Unpublished study prepared by Monsanto
Co. 172 p.

41096101 Leiber, M. (1988) Vapor Pressure Determinations for
Glyphosate and MON-7200/15100: Project No. MSL-7642; R.D.
No. 924. Unpublished study prepared by Monsanto
Agricultural Co. 59 p.
C-27
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00061553 Monsanto Company (1974) Residue Results. (Unpublished study
received on unknown date under 524-EX-24; CDL:095345-F)

00051980 Monsanto Company (1975) Residue Results. (Unpublished study
received Jun 3, 1976 under 524-308; CDL:096177-D)

00053002 Monsanto Company (1980) Summary: Glyphosate. Includes
undated method entitled: Analysis of Glyphosate in
cranberries; undated method entitled: Glyphosate and
metabolite; and undated method entitled: Procedure for
Glyphosate and Aminomethylphosphonic acid analysis of
cranberries. (Reports by various sources; unpublished study
received Sep 18, 1980 under 524-308; CDL: 099624-A)

00108102 Keckemet, O. (1975) The Results of Tests on the Amount of
Residue Remaining, Including a Description of the Analytical
Methods Used: Endothall. (Unpublished study received Feb 1,
1975 under 4G1449; submitted by Pennwalt Corp., Tacoma, WA;
CDL: 093861-A)

00136339 Thompson, C.; Mcallister, W. (1978) Acute Toxicity of
Technical Glyphosate (AB-78-165) to Rainbow Trout (Salmo
gairdneri). (Unpublished study received Dec 5, 1978 under
524-308; prepared by Analytical Bio Chemistry Laboratories,
Inc., submitted by Monsanto Co., Washington, DC;
CDL:097661-B)

00005298 Arthur, B.W.; Casida, J.E. (1958) Biological activity of
several O,O-Dialkyl alpha-acyloxyethyl phosphonates.
Agricultural and Food Chemistry 6(5):360-365. (Report no.
1868; also an unpublished submission received Aug 18, 1966
under 7F0612; submitted by Chemagro Corp., Kansas City, Mo.;
CDL:090796-W)

00152766 Forbis, A. (1983) Acute Toxicity of Inert Ingredient to
Bluegill Sunfish (Lepomis macrochirus): Static Bioassay
Report No. 30414. Unpublished Monsanto Study No. AB-83-121
prepared by Analytical Bio-Chemistry Laboratories, Inc. 46
p.

00152903 Cohle, P.; McAllister, W. (1983) Acute Toxicity of Passage
to Bluegill Sunfish (Lepomis macrochirus): Report #30411.
Unpublished study prepared by Analytical Bio-Chemistry
Laboratories, Inc. 45 p.

00155477 Watkins, C.; Thayer, D.; Haller, W. (1985) Toxicity of
adjuvants to bluegill. Bull. Environ. Contam. Toxicol.
34:138-142.

00026489 Fraser, W.D.; Jenkins, G. (1972) The Acute Contact and Oral
Toxicities of CP67573 and Mon2139 to Worker Honey Bees.
C-28
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(Unpublished study received on unknown date under 4G1444;
prepared by Huntingdon Research Centre, submitted by
Monsanto Co., Washington, D.C.; CDL:093848-R)

41728701 Stout, L.; Ruecker, F. (1990) Chronic Study of Glyphosate
Administered in Feed to Albino Rats: Lab Project Number:
MSL-10495: R.D. 1014. Unpublished study prepared by
Monsanto Agricultural Co. 42 p.

41689101 Castle, S.; Ruzo, L.; Kathryn, S. (1990) Degradation Study:
Photodegradation of Carbon 14 Glyphosate in a Buffered
Aqueous Solution at pH 5, 7 and 9 by Natural Sunlight: Lab
Project Number: 233W-1: 233W: 1020. Unpublished study
prepared by Pharmacology and Toxicology Research Laboratory,
Inc. 105 p.

42372501 Honegger, J. (1992) Addendum to MSL-10578 Aerobic Metabolism
of carbon 14 Glyphosate in Sandy Loam and Silt Loam Soils
with Bipmeter Flask: Supplement to MRID 41742901:
Unpublished study prepared by Monsanto Agricultural Comp.
10 p.

42372502 Honegger, J. (1992) Addendum to MSL-10577: Anaerobic Aquatic
Metabolism of carbon 14 Glyphosate: Supplement to MRID
41733701: Unpublished study prepared by Monsanto
Agricultural Comp, 19 p=

423725C3 Honegger, J, {1992) Addendum to MSL-10576: Aerobic Aquatic
Metabolism of ocarbon 14• Glyphosate: Supplement to MRID
41723601: Unpublished study prepared by Monsanto
Agricultural Comp, 6 p.

42383201 Goure, W, (1992) Aquatic Dissipation of Glyphosate and AMPA
in Water and Soil Sediment Following Application of
Glyphosate in Irrigated Crop and Forestry Uses: Addendum to
MSL-8332/Supplement to RD 898. Unpublished study prepared
by Monsanto Ag. Co. 36 p.

41552801 Honer, L. (1990) Dissipation of Glyphosate and
Aminomethylphosphonic Acid in Forestry Sites: Lab Project
Number: MSL-9940; 993. Unpublished study prepared by
Monsanto Agricultural Co. 555 p.

42372504 Honegger, J. (1992) Addendum to MSL-9811: Confined
Rotational Crop Study of Glyphosate. Part II: Quantitation,
Charaterization, and Identification of Glyphosate and its
Metabolites in Rotational Crops: Supplement to MRID
41543202: Unpublished study prepared by Monsanto
Agricultural Comp. 10 p.

41543201 Nicholls, R. (1990) Confined Rotational .Crop Study of
C-29
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Glyphosate Part I: In-Field Portion: Lab Project Number:
EF-88-22. Unpublished study prepared by Pan-Agricultural
Labs. , Inc. 115 p.

41543202 McMullan, P.; Honegger, J. ; Logusch, E. (1990) Confined
Rotational Crop Study of Glyphosate Part II: Quantisation,
Characterization and Identification of Glyphosate and Its
Metabolites in Rotational Crops: Lab Project Number:
MSL-9811. Unpublished study prepared by Monsanto
Agricultural Labs. 81 p.

42372505 Goure, W. (1992) Addendum to MSL-7633: Irrigated Crop Study.
42372505 Goure^
-------
Unpublished study prepared by Monsanto Co. 121 p.

00159419 Kuntsman, J. (1985) Validation of a New Residue Method for Analysis
of Glyphosate and Aminomethylphosphonic Acid (AMPA) - A Round-
robin Study: Report No. MSL-4268: Job/Project No. 7163. Un-
published study prepared by Monsanto Co. and others. 103 p.

00164729 Danhaus, R. (1986) Reanalysis of Water, Cotton, Soybeans, Pasture
Grasses, Alfalfa and Other Legumes for Glyphosate and Amino-
methylphosphonic Acid: MSL-4500. Unpublished study prepared
by Monsanto Co. 84 p.

40502601 Kunstman, J. (1987) Glyphosate Residues in Milo Grain and Fodder
Following Preharvest Applications with Roundup Herbicide: MSL-
,6919. Unpublished study prepared by Monsanto Co. 110 p.

00061553 Monsanto Company (1974) Residue Results. (Unpublished study re-
ceived on unknown date under 524-EX-24; CDL:095345-F)

40502605 Mueth, M. (1988) Storage Stability of Glyphosate in Crops and Wa-
ter - Status Report: 0066300. Unpublished compilation prepared
by Monsanto Co. 141 p.

40532004 Manning, M. (1988) Storage Stability Study of Glyphosate and AMPA
in Swine Tissues, Dairy Cow Tissues and Milk, Laying Hen
Tissues and Eggs: Laboratory Project ID MSL-7515. Unpublished
study prepared by Monsanto Company. 204 p.

41940701 Mueth, M. (1991) Storage Stability of Glyphosate Residues in Crop
Commodities: Lab Project Number: MSL-10843: 1051. Unpublished
study prepared by Monsanto Agricultural Co. 193 p.

40785302 Mueth, M. (1988) Glyphosate Residues in Potatoes and Processed
Fractions of Potatoes After Treatment with Roundup Herbicide:
Project ID. MSL-7877. 301 p.

40835201 Baron, J. (1988) Glyphosate—Magnitude of Residue on Turnip:
IR-4 Project 3204. Unpublished study prepared by IR-4
Northeast Analytical Lab. 82 p.

40783101 Baron, J. (1988) Glyphosate—Magnitude of Residue on Onions: IR-4
Project 3205, 3206, 3207. Unpublished study prepared by IR-4
Northeast Analytical Lab. 97 p.

40802801 Baron, J. (1988) Glyphosate - Magnitude of Residue on Broccoli:
Project ID. PR-3210. Unpublished study prepared by IR-4
Northeast Analytical Laboratory. 42 p.

00156793 Kunstman, J. (1983) Glyphosate Residues in Soybeans and Soybean
Fractions following Recirculating Sprayer and Preharvest Topical
Treatments with Roundup Herbicide: Report No. MSL-3259: Project
C-31
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No. 7163. Unpublished study prepared by Monsanto Co. 117 p.

40159401 Beasley, R. (1987) Determination of CP 67573 and CP 50435 Residues
in Citrus Process Fractions: Additional Information in Response
to the Guidance Document for Glyphosate Registration and Speci-
fically the Previously Submitted Glyphosate Residue Chemistry
Study for Citrus Fruits. Unpublished study prepared by Mon-
santo Agricultural Co. 12 p.

00053002 Monsanto Company (1980) Summary: CGlyphosate|. Includes undated
method entitled: Analysis of Glyphosate in cranberries; undated
method entitled: Glyphosate and metabolite; and undated method
entitled: Procedure for Glyphosate and Aminomethylphosphonic
acid analysis of cranberries. (Reports by various sources;
unpublished study received Sep 18, 1980 under 524-308; CDL:
099624-A)

40785303 Adams, S. (1988) Glyphosate Residues in Grapes and Grape Processing
Commodities Following Directed Spray Treatment with Roundup
Herbicide: Project ID. MSL-8027. Unpublished study prepared
by Monsanto Agricultural Co. 121 p.

40502602 Kunstman, J. (1987) Glyphosate Residues in Corn Grain and Fodder
Following Preharvest Applications with Roundup Herbicide: MSL-
6638. Unpublished study prepared by Monsanto Co. 176 p.

10502604 Kunstman, J« (1987) Glyphosate Residues in Corn Grain Fractions
Following Preharvest Applications to Corn with Roundup Herbi-
cide: MSL-6917. Unpublished study prepared by Monsanto Co.
195 p.

41478101 Kunda, U. S. (1990) Glyphosphate Residues in or on Corn Grits and
Flour Following Preharvest Application of Roundup Herbicide to
Corn: Lab Project Numbers MSLr9797. Unpublished study prepared
by Monsanto Agricultural Co., in cooperation with Texas ASM
Univ. Food Protein Research Center. 88 p.

40502601 Kunstman, J. (1987) Glyphosate Residues in Milo Grain and Fodder
Following Preharvest Applications with Roundup Herbicide: MSL-
6919. Unpublished study prepared by Monsanto Co. 110 p.

40502603 Huntsman, J. (1987) Glyphosate Residues in Milo Grain Fractions
Following Preharvest Applications to Milo with Roundup Herbi-
cide: MSL-7043. Unpublished study prepared by Monsanto Co.
138 p.

41484301 Aliin, J. (1989) Glyphosate Residues in Wheat Grain and Straw aftei
Preharvest Treatment with Roundup Herbicide: R.D. No. 983.
Unpublished study prepared by Monsanto Agricultural Co. 436 p.

00150835 Monsanto Co. (1984) ^Glyphosate Residues in Wheat Grain, Straw and
C-32
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Milling/Fractionation Products following Ropewick Wiper Treat-
ment with Roundup Herbicide". Unpublished compilation. 158 p.

00109271 Monsanto Co. (19??) Crop Residues and Tolerances. (Unpublished
study received Apr 9, 1982 under KS 82/1 for Monsanto; CDL:
247348-B)

40502601 Kunstman, J. (1987) Glyphosate Residues in Milo Grain and Fodder
Following Preharvest Applications with Roundup Herbicide: MSL-
6919. Unpublished study prepared by Monsanto Co. 110 p.

40541304 Mueth, M. (1988) Volume 4: Glyphosate Residues in Alfalfa Hay and
Seed following Scattered Spot Treatment with Roundup Herbicide:
Laboratory Project No. MSL-7482. Unpublished study prepared by
Monsanto Co, 121 p.

4C6424Q1 Baron, J. (1988) Glyphosate—Magnitude of Residue on Asparagus:
Laboratory Project ID: PR 3212. Unpublished study prepared by
NY State Agricultural Experiment Station. 69 p.

40149401 Sheldon, A. (1986) Triphenyltin Hydroxide—Responses to Questions
in the EPA Letter September 24, 1986 (Jacoby to Sheldon). Un-
published study prepared by M&T Chemicals Inc. 15 p.

00051981 Monsanto Company (1973) Master Summary Table of PPM Residues of
Glyphosate (CP67573) and Glyphosate Metabolite (CP50435) in
Green Gaffes Bean Studies Using a Single Directed Post-emergent
Application. (Unpublished study received Jun 3, 1976 under
524-308? CDL:096177-E)

40580401 Baron, J. (1988) Glyphosate—Magnitude of Residue on Mango: Project
ID: IR-4 PR-3213. Unpublished study prepared by IR-4 Northeast
Analytical Laboratory., 35 p.

42398401 Hontis, A. (1992) Residues of Glyphosate/AMPA in Olives and
Olive Oil Following Use of Sting SE—-Spanish Field Trials
1990-1992: Lab Project Number: 1115: MLL-30297. Unpublished
study prepared by Monsanto Agricultural Co. 73 p.

00144341 Steinmetz, J. (-1984) Glyphosate Residues in Peanuts and Peanut
Fractionation Products Following Postemergent Polyester/Acrylic
Pipewick Treatments with Roundup Herbicide: Report No. MSL-3392;
Job/Project No. 7163. Unpublished study prepared by Monsanto
Co. in cooperation with ABC Laboratories, Inc. and Craven Labor-
atories, Inc. 116 p.

40541305 Kunstman, J. (1988) Volume 5: Irrigated Crops Study—Determination
of Glyphosate Residues in Crops, Irrigation Water, Sediment, and
Soil following Treatment of Irrigation Source with Rodeo: Labo-
ratory Project No. MSL-7633. Unpublished study prepared by Mon-
santo Agricultural Co. 203 p.
C-33
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40532001 Manning, M.; Wilson, G. (1987) Residue Determination of Glyphosate
and AMPA in Laying Hen Tissues and Eggs Following a 28-Day
Feeding Study: Laboratory Project ID MSL-6676. Unpublished
study prepared by Monsanto Company. 192 p.

40532002 Manning, M.; Wilson, G. (1987) Residue Determination of Glyphosate
and AMPA in Swine Tissues Following a 28-Day Feeding Study:
Laboratory Project ID MSL-6627. Unpublished study prepared by
Monsanto Company. 147 p. ,

40532003 Manning, M.; Wilson, G. (1987) Residue Determination of Glyphosate
and AMPA in Dairy Cow Tissues and Milk Following a 28-Day
Feeding Study: Laboratory Project ID MSL-6729, Unpublished
study prepared by Monsanto Company, 180 p.

00154311 Armstrong, T., Comp. (1985) static Marine Mollusk (Rangia cuneata)
Bioconcentration Study with Water-applied tfCarbon-14~-Glypho-
sate and "Non-aged" Sandy Loam Soil Substrate, Part I and Part
II: Special Report MSL-5159. Unpublished compilation prepared
by Monsanto Agricultural Products Co. in cooperation with
Analytical Bio-Chemistry Labs. 293 p.

00155120 Armstrong, T., comp. (1985) Static Crayfish (Procambarus simulans
Faxon) Bioconcentration Study with Water-applied tfCarbon 14"-
Glyophosate and "Non-aged" Sandy Loam Soil Substrate, Part I anc
Part II o Unpublished compilation prepared by Monsanto Co. 324p,
C-34
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Appendix D

List of Available Related Documents
The following is a list of available documents related to
glyphosate. Its purpose is to provide a path to more detailed
information if it is required. These accompanying documents are
part of the Administrative Record Jor glyphosate and are included
in the EPA's Office of Pesticide Programs Public Docket.

1, Health and Environmental Effects Science Chapters

2» Detailed Label Usage Information System (LUIS) Report

3. Glyphosate RED Fact Sheet (included in this RED)

4. PR Notice 91-2 (Included in this RED) Pertains to the
Label Ingredient Statement

5. Complete Appendix A which details the use patterns
subject to reregistration

Federal publications on glyphosate are available and may be
purchased from the National Technical Information Service (NTIS),
5285 Port Royal Road, Springfield, VA 22161.

1. Pesticide Fact Sheet (No. EPA-738-F-93-011) for
Glyphosate

2. Registration standard for Pesticide Products Containing
Glyphosate as the Active Ingredient (The 1986
Registration Standard): NTIS Stock No. PB87-103214
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Appendix E
Pesticide Reregistration Handbook
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PESTICIDE REREGI8TRATION HANDBOOK
HOW TO RESPOND TO THE

REREGISTRATION ELIGIBILITY DOCUMENT (RED)
OFFICE OF PESTICIDE PROGRAMS

ENVIRONMENTAL PROTECTION AGENCY

OCTOBER 1991
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PRODUCT REREGISTRATION HANDBOOK
TABLE 07 CONTENTS
Introduction
A. Purpose and Content
B. Reregistration Eligibility Document
C. Reregistration Process
II. Instructions for Responding
A. How and When to Respond
B. When No Response Is Needed
B. Where to Respond
III. Submission of Data and Labels/Labeling
A, Generic Data
B. Product Specific Data
1. Product Chemistry
2. Acute Toxicity
3. Product Performance
Labels/Labeling
Appendix
8
10
A. Confidential Statement of Formula and Instructions
B. Label Contents
C. Sample Label Formats—General Use & Restricted Use
D. Label Regulations (40 CFR 156.10)
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PESTICIDE REREGISTRATION HANDBOOK

I. INTRODUCTION

A. Purpose and Content of this Handbook

This Handbook provides instructions to registrants on how to
respond to the Reregistration Eligibility Document (hereafter
referred to as the "RED") and how to reregister products.

Section I is this introduction.

Section II contains step-by-step instructions which must be
followed by registrants responding to the RED.

Section III provides additional instructions on the format,
content and other aspects of generic data, product specific data
and labc?s/labeling which may be required to be submitted.

Detailed instructions are in the Appendix.

B.. The Reregistration Eligibility Document (RED)

Under Section 4 of the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA), as amended in 1988, EPA is required to
reregister pesticides that were first registered before November 1,
1984. The RED describes in detail the subject chemical, its uses
and its regulatory history; describes EPA's decision concerning the
eligibility of the uses of the chemical for reregistration; and
explains the scientific and regulatory bases for this decision.
EPA's reviews of the data by scientific discipline are available
upon request. Appendices to the RED contain: (1) a Data Dall-In
Notice which requires submission of .generic and product specific
data and which gives directions for responding, (2) a listing of
existing studies that satisfy generic data requirements and (3) a
bibliography of the generic studies EPA has reviewed.

C. The Rereaistration Process

Reregistration involves a thorough review of the scientific
data base underlying a pesticide's registration. The purpose of
EPA's review is to reassess the potential hazards arising from the
currently registered uses of the pesticide, to determine whether
the data base is substantially complete or there is need for
additional generic data, and to determine whether the pesticide is
eligible for reregistration. This decision, is issued as the RED.
1 EPA's science reviews and information on the registered
uses considered for EPA's analyses may be obtained from: EPA,
Freedom of Information, 401 M St., S.W., Washington, D.C. 20460.
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If the RED declares that some or all uses of the chemical are
eligible for reregistration, affected registrants must first
respond within 90 days of receipt to the data call-in portion of
the RED. Within 8 months of receiving the RED, registrants must
submit or cite any data and labels/labeling required for each
product. EPA has until 14 months after the RED is issued (i.e.,
6 months after the registrants' 8 month deadline) to review the
submission for each product and decide whether to reregister it
based on the 'following criteria!

—whether all of the product specific data and labels/labeling
are acceptable,

--whether all of the uses on the label/labeling are eligible,

—whether all of the active ingredients in the product are
eligible, and
'' ' '' +&
—if no List 1 toxic inert ingredient is contained in the
product (a List 1 inert is permitted only if all data
for it have been submitted and 1PA determines
that the inert does not pose any unreasonable adverse
effects in that product),
Products which n@@t all of these criteria will be
r«regist«re*S. Products which do not meet all of these criteria,
but which have acceptable product specific data and labeling, will
be processed as amendments in order to implement label changes
required by the RED..

II. INSTRUCTIONS"FOR RESPONDING

A. How and When to Respond

This section provides directions for submitting timely and
adequate responses necessary to reregister products containing the
active ingredient covered by the RED. Registrants must follow
these steps exactly to avoid suspension of their products. All
products containing tho active ingredient in the RED [i.e.,
manufacturing use products, end us* products and special local need
(SLN or Section 24c) registrations] ar* subject to the requirements
of th* RED. Figur* 1 summarizes how and when to respond to the
RED. A step-by-step explanation follows.

Step 1. Are Expedited Label Changes Required? In some
instances, EPA may conclude -that certain changes to product
labels/labeling must be implemented rapidly. If the RED requires
expedited label/labeling changes, registrants must submit the items
below by the deadline specified in the RED. If expedited label
changes are not required, go to Step 2.

a. Application for Registration (EPA Form 8570-1). Complete
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and sign the form. In Section II, insert the phrase "Expedited
Amendment in Response to the Reregistration Eligibility Document
for (insert ease name for chemical) ." Applications for expedited
label changes will be processed as applications for amended
registration. Use only an original application form with m red
identifier number in ';he upper right-hand corner.

b. Jive (5) ropies of revised draft label and labeling.
Refer to the RED -for label/labeling changes and follow the
instructions in Section Ill.c. and the Appendix of this Handbook
for revising the label and labeling for each product.

Step 2. Are data requ'^ed? If the RED requires generic or
product specific data, you nust follow the directions in the data
call-in notice in the RED. All registrants must respond for all
products within 90 davs of receipt; products for which an adequate
response is not received on time will be subject to suspension. No
time extensions will be given for responding within 90 days.

?• Are Uses of a Pesticide Eligible for Rereqistration?
If any uses of the active ingredient (s) covered by the RED are
eligible for reregistration, follow these instructions. If pp uses
are eligible, &S further response may be needed (see page 5) ,

EPA's decision on the eligibility of each of the uses of the
active ingredient (s) is presented in the RED. If any uses of a
chemical are eligible for reregistration, registrants for
manufacturing-use products (MPs) , end-use products (EPs) and
special local needs registrations (SLNs) , must submit the items
below for each product within 8 months of the date of issuance of
the RED:

a. Application for Reregistration (use EPA Form 8570-1).
Complete and sign the form'. In Section II of that form, check the
box "Other" and insert the phrase "Application for Reregistration."
Use only an original application form with a red identifier number
in the upper right-hand corner.

b. rive (5) copies of revised draft label and labeling.
Refer to the RED for labeling changes specific to the active
ingredient, follow the instructions in Section XII. c. of this
Handbook and refer to the Appendix of this Handbook for guidance on
current requirements for labels and labeling. If there are
ineligible uses on the label or labeling, you may delete such uses
and avoid all requirements and consequences which may be associated
with ineligible uses (e.g, generic data requirements, cancellation,
suspension, etc.). If you delete certain uses now and those uses
become eligible for reregistration later, you must submit an
amendment application to add those uses back to the label.
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FIGURE 1. HOW AND WEEN TO RESPOND TO THE REREGISTRATION
ELIGIBILITY DOCUMENT (RED) FOR MANUFACTURING USE
PRODUCTS (MPs), END-USE PRODUCTS (EPS) and SPECIAL
LOCAL NEEDS REGISTRATIONS (SLNs).
STEP is A.-a expedited label revisions required?

Yes ^S No

Submit application
and labels on
expedit
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c. Product Specific Data. You mu»t follow the instructions
in the Data Call-in notice in the RED and in Section III of this
Handbook. Responses to th« data call in ar« du« vithin 90 days of
r«c«ipt of the RED and submission or citation of data is du« vithin
8 months of the issuance of the RED.

d. Two (2) copies of th« currant Confidential statement of
Formula (EPA Form 8570-4, revised Febrvary 85). Two completed and
signed CSF forms must be submitted for the basic formulation and
for each alternate formulation. If CSFs are not provided for the
alternate formulas, they will not be reregistered and will no
longer be acceptable. The Appendix of this Handbook has specific
instructions for completing the CSF form.

e. Certification With Respect to Citation of Data (EPA Fora
8570-31). This form must be completed, signed and submitted for
each product to assure that the data compensation provisions of
FIFRA are met.

B. When No Response is Needed

If no uses of a pesticide are eligible for reregistration, it
is unlikely that you will be required to submit product specific
data or labeling. Uses of an active ingredient may be declared
ineligible fos: reregistration for two possible reasons:

--Available data indicate that one or more of the criteria for
an in-depth special review have been met;

—Additional generic data are required.

In the first instance, if the active ingredient is placed into
special review, reregistration activities associated with those
uses of the chemical are stopped until EPA makes a final
determination. At that time, EPA will indicate which uses may be
eligible for reregistration and which uses are to be cancelled. If
some or all of the previously ineligible uses become eligible for
reregistration, EPA will start the reregistration process for
products containing only eligible uses.

In the second instance, based upon the review of studies for
an active ingredient during reregistration, additional generic data
(e.g., second- or third-tier studies) may be needed (see the RED).
In such cases, the chemical's uses will not be eligible for
reregistration until the additional 'generic data have been
submitted to and reviewed and found acceptable by EPA. If the data
are reviewed and found to be acceptable, EPA will indicate which
uses will be eligible for reregistration and will initiate
reregistration of products containing previously ineligible uses.
If the data are not submitted, products containing the active
ingredient may be suspended.
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C. Where to Respond

By U.S. Mail:

Document Processing Desk (insert distribution code)
Office of Pesticide Programs (H7504C)
Environmental Protection Agen'zy
401 M Street, S.W.
Washington, D.C. 20460-0001

By express nail or by hand delivery:

Document Processing Desk (insert attribution code)
Office of Pesticide Programs (H7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202

•>' These nailing addresses and the following distribution codes
nust be used to assure the timely receipt and processing of your
submissions. Not using them may significantly delay the handling
of your submissions:
(where XJSK is the ease code given on the front of
the j&Ed) --use this distribution code for all responses pertaining
to or containing generic data. Such responses include the 90-day
response forms for generic data or hard copies of generic data.

RED-RD-PKxx (where xx is the Product Manager teaa number) —
use this distribution code for all responses pertaining to or
containing product specific data or labeling. Such responses would
include expedited labeling amendments, 90-day responses to product
specific data requirements, hard copies of product specific data
and applications for reregistration.
III. SUBMISSION OF DATA AND LABELS/LABELING

This section provides additional instructions concerning
responses required for generic data, product specific data and-
labels/labeling.

A. Generic Data

During EPA's evaluation of an- active ingredient for
reregistration, additional generic data requirements may be
identified that registrants nust fulfill. In some instances these
data requirements would have to be satisfied before an active
ingredient or some of Its uses could be declared eligible for
reregistration. In other cases, these new data requirements would
not affect the eligibility of the active ingredient, but would be
necessary to confirm EPA's assessment of that chemical.
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Any new data requirements and how they affect reregistration
eligibility of a chemical are discussed in the RED. If new generic
data requirements are imposed in a Data Dall-In Notice in the RED,
registrants must respond as described in that Notice. The RED also
contains instructions for completing these forms, a citation of
EPA's legal authority for requiring the new data, a listing of
options available to registrants for satisfying the data
requirements and the name of the contact person for .inquiries.

B. Product Specific Data

Product specific data may be required for the reregistration
of each pesticide product in three areas— product chemistry, acute
toxicity and efficacy,

1. Product Chemistry

Following are instructions for submitting product-specific
data and a discussion of EPA's policy on inert ingredients.

a. Data

All data requirements for MPs, EPs and SLNs (24c's) are
in the Data Call-in Notice in the RED. In addition:
—If you cite data from another identical, registered
product , you must identify the EPA registration number of that
product,

—If the product-specific data submitted or cited do not
pertain to an identical formulation to the product submitted for
reregistration, then new product-specific data are required to be
submitted by the deadline specified in the Data Call-in Notice.
The only exception is for products which EPA "groups" together a
being similar enough to depend on the same data. Such groupings
are discussed in the appendix to the RED (for acute toxicity
purposes, for example), if it was feasible to do so.

b. Inert Ingredients

EPA has implemented a strategy for regulating inert
ingredients which affects the reregistration of pesticide products.
This strategy, issued on April 22, 1987 (52 FR 13305-13309) and
updated on November 22, 1989 (54 FR 48314-48316), adopted certain
policies designed to reduce the potential for adverse effects from
pesticide products containing intentionally added inert
ingredients. EPA divided the known inert ingredients into four
categories :

— Inerts of toxicological concern (List 1) for which available
data demonstrate toxic effects of concern (includes about 50
chemicals) .
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8

—Potentially toxic inerts (List 2) for which only limited
data are available, but such data or the chemical structure suggest
the potential for toxicity (includes about 60 chemicals).

—Inerts of unknown toxicity (List 3) for which no data or
bases for suspecting toxic effects ar« available (includes up to
2,000 chemicals).
—Inerts of minimal concern (List 4) which ire
regarded as innocuous (includes about 290 chemicals).
generally
When a RED is Issued and any uses of an active ingredient are
dsslared. eligible for reregistration, all products containir-n that
active ingredient will foe subject to reregistration* EPA will, as
part of the reregistration review, examine the inert ingredients of
each product prior to reregistration to ensure that they do not
present unreasonable risks. In reviewing the product chemistry
data, EPA will identify List 1 inerts. EPA will continue to
encourage registrants to eliminate any List 1 inerts present.
Reregistration of products containing only List 2, 3 or 4 inerts
be unaffected by the inerts strategy.

Consistent with th© strategy on inerts, a product containing
i laert ingradisat will not b© ?«regist«r«& until a full
assessment of tho product has b&en conducted, based on the
data called in for that inert ingredient. However, the existing
registration of a product containing a List 1 inert will remain
valid as long as the product bears the required label warning and
is in compliance with any outstanding DCI, or other activity under
the inerts strategy,

Any product containing a List 2, 3 or 4 inert nay be
reregistered if it meets all other requirements for reregistration.
As the inerts strategy is implemented and data for the List 2 and
3 inerts are reviewed, EPA may move these inerts to the other
Lists. If an inert were moved to List 1, products containing that
inert would become ineligible for reregistration. Inert
ingredients must also meet normal registration and tolerance
requirements, as applicable.

2. Acute Toxicitv

The data call-in notice in the RED specifies the acute
toxicity data required for reregistration of each MP or EP. It
indicates whether any of the standard tests have been waived and,
if so, why.

If feasible, EPA will "batch" products that are similar with
respect to their acute toxicity so that one set of tests can
support reregistration of each baatch of products. This approach
will impose the least amount of testing necessary to adequately
support the registration and labeling for pesticide products. The
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main benefits of this approach are to minimize the need for animal
testing, reduce the expense to registrants to generate the tests
and decrease the resources EPA must spend on reviewing data.
Registrants may contact other registrants with products in the same
"batch" to decide whether to provide or depend on one set of data;
alternatively, registrants may choose to conduct their own studies.

3. Product Performance
/_ . ;
Consult the Data Call-in section of the RED to determine
whether Product Performance data are required for your product.

Product performance (efficacy) data are generated in studies
designed to document how candidate pesticide formulations perform
as pest control agents. These data include tests run to determine
whether a formulation is lethal to certain pest species, to
document the effectiveness of the formulation in controlling pest
species in actual use situations, and to determine whether certain
claims"beyond mere control of a pest (e.g., "six-month residual
effect," "kills Warfarin resistant house mice," etc.) are
justified.

EPA has standard protocols for certain efficacy tests. In
general, standard methods have been developed for tests needed to
substantiate claims that have been made frequently for pesticide
products. As the scope of potential pesticidal claims is extremely
broad, the Agency does not have standard methods for tests needed
to substantiate many pesticide claims, especially those that are
uncommon. The Product Performance Guidelines, Subdivision 6, offer
general guidance for developing protocols for efficacy testing.
Proposed protocols should be submitted to EPA for review before
tests are initiated.

a. Efficacy Data Submission Waiver Policy

FIFRA gives the Administrator of EPA authority "to waive data
requirements pertaining to efficacy" but does not require that
efficacy data requirements be waived for any class of pesticide
product registered under Section 3 of the Act. As a matter of
policy, EPA does not require submission of efficacy data to support
many types of pesticidal claims but does require submission of such
data for certain types of claims. As noted in 40 CFR 158.640, this
waiver applies to the submission of efficacy data rather than to
the generation of efficacy data. EPA expects each registrant to
"ensure through testing that his products are efficacious when used
in accordance with commonly accepted pest control practices."

This general policy notwithstanding, EPA may, at any time,
require a registrant to submit efficacy data to support any claim
made for a product. EPA also may require that certain claims of
effectiveness be established before a Section 3 registration is
granted.
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10

b. Claims and Products for Which Efficacy Data Generally
Are Re cm ired

Submission of efficacy data at reregistration typically is
required for the following types of products:

1. products claimed to control microorganisms that
pose potential threats to public health?

2. products claimed to control vertebrate pests that
may directly or indirectly transmit diseases to
humans?

3. potentially very hazardous products for which EPA
determines that it is necessary to conduct a "risk-
benefits'" analysis;

4. products of types for which EPA has reasons (e.g.,
consumer complaints, unlikely claims, unusual use
patterns, etc.) to question claims? and

C. Labels and Labeling

Tc reaain in compliance with FIFRA, the label and" labeling of
each product must be revised to meet the requirements for
reregistration as described below. "Labeling" includes the
container label and-any written, printed or graphic matter that
accompanies the pesticide in U.S. commerce at any time (such as
technical bulletins, collateral labeling, etc.). Applications for
aew uses or labeling changes that do aot pertain to reregistration
must be filed separately from the application for reregistration
described in Step 3 earlier. Changes to labeling which must be
made for reregistration include, but are not limited to:

1. Labeling changes specified in the RED. Such changes may
include statements on RESTRICTED USE, groundwater hazards,
protective clothing/equipment, endangered species, environmental
hazards, etc.

2. The format and content of labeling as described in 40 CFR
156.10. When further acute testing is needed, the currently
accepted precautionary statements will usually be retained until
testing is completed and the data are reviewed.

3. Labeling changes required by -Pesticide Regulatory ($R)
Notices, regulations, regulatory decisions and policies issued by
EPA which are relevant to the pesticide. Your product's labeling
must reflect any applicable requirements which are in effect at the
time the RED is issued. Some existing notices are referred to in
Section B. of the Appendix. •
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APPENDIX
A. Confidential Statement of Formula and Instructions
B. Instructions for Label Contents :
C. Sample Label Formats—General Use & Restricted Use
D. Label Regulations (40 CFR 156.10)
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i
w

I
I
i
aa
E

hs
i*
lt
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Instructions for Completing the Confidential Statement of
Formula • •

The Confidential Statement of Formula (CSF) Form 8570-4 must
be used. Two legible, signed copies of the form are required.
Following are basic instructions:

a. All the blocks on the form must be filled in and answered
completely.

b. If any block is not applicable, mark it N/A.

c. The CSF must be signed, dated and the telephone number of
the responsible party must be provided.

d. All applicable information which is on the product-
specific data submission must also be reported on the CSF.

e. All weights reported under item 7 must be in pounds per
gallon for liquids and pounds per cubic feet for solids.

f. Flashpoint must be in degrees Fahrenheit and flame
extension in inches.

g. For all active ingredients, the EPA Registration Numbers
for the currently registered source products must be reported under
column 3.2.

h. The Chemical Abstracts Service (CAS) Numbers for all
actives and inerts and all common names for the trade names must be
reported»

i. For the active ingredients, the percent purity of the
source products must be reported under column 10 and must be
exactly the same as on the source product's label.

j. All the weights in columns 13.a. and 13.b. must be in
pounds, kilograms, or grams. In no case will volumes be accepted.
Do not mix English and metric system units (i.e.,. pounds and
kilograms).

k. All the items under column 13.b. must total 100 percent.

1. All items under columns 14.a. and 14.b. for the active
ingredients must represent pure active form.

m. The upper and lower certified -limits for all active and
inert ingredients must follow the 40 CFR 158.175 instructions. An
explanation must be provided if the proposed limits are different
than standard certified limits.

n. When new CSFs are submitted and approved, all previously
submitted CSFs become obsolete for that specific formulation.
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.B. INSTRUCTIONS FOR LABEL CONTENTS

40 CFR 156.10 and Pesticide Regulatory (P.R.) Notices require
that specific labeling statements appear at certain locations on
the label. The sample label formats in Appendix C show where these
statements are to be placed.

Item 1, PRODUCT NAME - The name, brand or trademark is required to
be located on the front panel, preferably centered in the upper
part of the panel. The name of a product will not be accepted if
it is false or misleading. [40 CFR 156.10(b)]

Itesn 2. COMPANY NAME AND ADDRESS - The name and address of the
producer, registrant'or person for whom the product is produced are
requia.-^ on the label and should be located at the bottom of the
'front panel or at the end of the label text. [40 CFR 156.10(c)]

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 e.nd of the label text. The net
contents smst be expressed in the largest suitable unit, e.g., "1
pound .10 ounces" rather than "2S ounces." In addition to English
units, net contents may be expressed in metric units. [40 CFR
156,10 (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 156.10(e)]

Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment number,
preceded by the phrase "EPA Est." is the final establishment at
which the product was produced, and may appear in any suitable
location on the label or immediate container. It must also appear
on the wrapper or outside container of the package if the EPA
establishment number on the immediate container cannot be clearly
read through such wrapper or container. [40 CFR 156.10(f)]

Item 6A. INGREDIENTS STATEMENT - An ingredients statement is
normally 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 156.10(g)]

Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricultural
-------
formulations, the pounds per gallon of active ingredient must be
indicated on the label. [40 CFR 156.10(h)(iv)]

Item 6C. NAMES TO BE USED IN INGREDIENT STATEMENT - The acceptable
common name, if there is one, shall be used, followed by the
chemical name. if no common name has been established, the
chemical name alone shall be used. Chemicals related to the active
ingredient are allowed to be listed only if efficacy data
supporting such claims are submitted or referenced. If such data
are provided, the releted chemicals must be listed separately and
not as a portion of the active ingredient.

Item 6D. INERT INGREDIENTS RECLASSIFIED AS ACTIVE INGREDIENTS - If
SPA has reclassified chemicals from inert ingredient status to
active ingredient status/ registrants of affected products must'
change th© ingredient statement accordingly (See 52 FR 13307-8,
April 22, 1987). if such pesticides have food uses, tolerances
must either be established for such uses, or an exemption from the
requirement for tolerances must be obtained.

Item 6E. NOMINAL CONCENTRATION - The amount of active ingredient
declared in the ingredient statement must be the nominal
•concentration of the product as defined in 40 CFR 158.153(i) and
described in P.R. Notice 91-2,

It*a> 7, WARNINGS AND 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 Signal Word "Keep Out of Reach
Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size

5 and under 6 point 6 point

above 5 to 10 10 point 6 point

above 10 to 15 12 point 8 point

above 15 to 30 14 point 10 point

over 30 18 point 12 point

Item 7A. CHILD HAZARD WARNING STATEMENT - The statement "Keep Out
of Reach of Children" must be located on the front panel above the
signal word except where contact with children during distribution
or use is unlikely. [40 CFR 156.lO(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 156.10(h)(1)(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 156.10(h)(l)(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
Item 7E. REFERRAL STATEMENT - The statement "see Side (or Back)
Panel for Additional Precautionary Statements" is required on the
front panel for all px^ucts, unless all «fP}^ PJf
statements appear on the front panel. [40 CFR 156. 10 (h)

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^dr 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 156. 10 (h) (2) ]

Xteia 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 156. 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 156.10(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
qeneral 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). If your product has been
classified for restricted use, then these requirements apply:
-------
3U1 uses restricted. The following statements must be placed
in a black box at the top of the front panel of the label and
labeling:
a,
b.
The statement "Restricted Use Pesticide*1 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
156.10 (h) (1) (iv) ]. No statemei ts of any kind may appear
above this RUP statement.

The reason.for the the restricted use classification must
appear below the RUP statement. The RED will prescribe
this statement* ••-..••.-
. statement of the terms of restriction must
appear directly below this reason statement on the front
panel. 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 isupervision and only for those uses covered
by the Certified Applicator's Certification.11 The RED
will specify what statement must be used.

2 Soss* fe'«t not all uass restricted. If the RED states that some
uses are (classifies 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 toeing unrestricted.

b* You may delete all restricted uses from your label and
submit draft labeling bearing only unrestricted uses.

c. You may "split" your registration, i.e., register two
separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted
simultaneously. Note that the products will be assigned
separate registration numbers.

Item 9B. MISUSE STATEMENT - All products must bear the misuse
statement, "It is a violation of Federal-law to use this product "in
a manner inconsistent with its labeling." This statement appears
at the beginning of the directions for use, directly beneath the
heading of that section.

Item 10A. REENTRY STATEMENT - If a restricted entry interval (REI)
has been established by the Agency, it must be included on the
label. Additional worker protection statements may be required in
-------
accordance with PR Notice 83-2, March 29, 1983.

Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are required to
bear storage and disposal statements. These statements are
developed for specific containers, sizes, and chemical content.
These instructions must be grouped and appear under the heading
"Storage and Disposal*1 in the directions for use. This heading
must be set in the same type sizes as required for the child hazard
warning. Refer to P.R. Notices 83 -3 and 84-1 to determine the
storage and disposal instructions appropriate for your products.

Item 10C» 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 156.10(i)(2)]

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 thos© accepted in connection with
registration of the product. Collateral labeling must be made part
of the response to the.RED and submitted for review.
-------
-------
LABEL FORMAT FOR UNCLASSIFIED PRODUCTS
ill
O
O
DC
i
v»
UJ

g
tu
UJ

u
ils
ft * h
i *
III
* X tf

llh
s <
I u
hi
i
w ™

fil
-------
LABEL FORMAT FOR PRODUCTS CLASSIFIED FOR RESTRICTED USE
o
tuco
O O

CC CO
P5
-------
Protection Aganey
emitter has asserted a confidential
lless information claim concerning
material).
rA copy of each document, propos-
i or other item of written material
Jnncerning the Registration Standard
Sovided by the Agency to any person
nr party outside of government
fwithin 15 working days after the item
Js made available to such person or

copy of the Registration Stand-
Witft respect to a Registration
Standard for which the Agency has
determined that a substantially com-
oiete chronic health and teratology
d»ta base exists, a copy of the FEDERAL
RSGISTER notice concerning availabil-
ity of a proposed Registration Stand-
ard, and a copy of each comment re-
ceived in response to that notice
(within 10 working days after receipt
by the Agency, or 15 working days if
the submitter has asserted a confiden-
tial business information claim con*
ceming the material).
<8) A copy of the FEDERAL REGISTER
notice announcing the issuance of the
Registration Standard (within 10
working days after the publication of
the notice).
(c) Index of the docket The Agency
wffl establish and keep current an
index to the docket for each Registra-
tion Standard. The index wiU include,
but is not limited to:
(1) A list of each meeting between
the Agency and any person or party
outside of government, containing the
date and subject of the meeting, the
names of participants and the name of
the person requesting the meeting.
(2) A list of each document in the
docket by title, source or recipient(s),
and the date the document was re-
ceived or provided by the Agency.
(d) Availability of docket and indi-
ces (1) The Agency will make avail-
able to the public for inspection and
copying the docket and index for any
Registration Standard.
(2) The Agency will establish and
maintain a mailing list of persons who
have specifically requested that they
receive indices for Registration Stand-
ard dockets. On a quarterly basis, EPA
wm distribute the indices of new mate-
rials placed in the public docket to
§ 156.10

these persons. Annually, EPA will re-
quire that persons on the list renew
their requests for inclusion on the list.
(3) The Agency will issue annually in
the FEDERAL REGISTER (in conjunction
with the annual schedule notice speci-
fied in 1155.25) a notice announcing
the availability of docket indices.
(4) Each FEDERAL REGISTER notice of
availability of a Registration Standard
will announce the availability of the
docket index for that Standard.

• 155.34 Notice of solubility.
(a) The Agency will issue in the FED-
ERAL REGISTER a notice announcing the
issuance and availability of Registra-
tion Standard which:
(1) Concerns a previously unregis-
tered active ingredient; or
(2) Concerns a previously registered
active ingredient, and the Registration
Standard states that registrants will
be required (under FIFRA section
3(c)(2)(B)) to submit chronic health
(including, but not limited to, chronic
feeding, oncogenicity and reproduc-
tion) or teratology studies.
(b) Interested persons may submit
comments concerning any Registra-
tion Standard described by paragraph
(a) of this section at any time.
(c) The Agency will issue in the FED-
ERAL REGISTER a notice announcing the
availability of, and providing opportu-
nity for comment on, each proposed
Registration Standard which concerns
a previously registered active ingredi-
ent for which the Agency has deter-
mined that a substantially complete
chronic health and teratology data
base exists. Following the comment
period and issuance of the Registra-
tion Standard, the Agency will issue in
the FEDERAL REGISTER a notice of avail-
ability of the Registration Standard.

PART 156—LABELING REQUIRE-
MENTS FOR PESTICIDES AND DE-
VICES

AUTHORITY: 7 U.S.C. 186-136y.

i 156.10 Labeling requirement*.
(a) General—U) Contents of the
label Every pesticide products shall
bear a label containing the informa-
tion specified by the Act and the regu-
75
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§156.10

lations in this Part The contents of a
label must show clearly and promi-
nently the following:
(i) The name, brand, or trademark
under which the product is sold as pre-
scribed in paragraph (b) of this sec-
tion;
(ii) The name and address of the
producer, registrant, or person for
whom produced as prescribed in para-
graph (c) of this section;
(ill) The net contents as prescribed
in paragraph (d) of this section;
<5v> The product registration
number as prescribed in paragraph The use classification^} as pre-
scribed in paragraph (J) of this section.
(2) Prominence and legibility. (i) All
words, statements, graphic representa-
tions, designs or other information re-
quired on the labeling by the Act or
the regulations in this part must be
clearly legible to a person with normal
vision, and must be placed with such
conspicuousness (as compared with
other words, statements, designs, or
graphic matter on the labeling) and
expressed in such terms as to render it
likely to be read and understood by
the ordinary individual under eustom-
-ary conditions of purchase and use.
(11) All required label text must:
(A) Be set in 6-point. or larger type;
(B) Appear on a clear contrasting
background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required
label or labeling text shall appear in
the English language. However, the
Agency may require or the applicant
may propose additional text in other
languages as is considered necessary to
protect the public. When additional
text in another language is necessary,
all labeling requirements will be ap-
plied equally to both the English and
40 C« Ch. I OT.1.49 .UIH«o

other-language versions of the label.
ing.
(4) Placement of Label—(i) General
The label shall appear on or be secure.
ly attached to the immediate contain.
er of the pesticide product. For pur.
poses of this Section, and the mis.
branding provisions of the Act, "se-
curely attached" shall mean that a
label can reasonably be expected to
remain affixed during the foreseeable
conditions and period of use. If the im-
mediate container is enclosed within &
wrapper or outside container through
which the label cannot be clearly read,
the label must also be securely at-
tached to such outside wrapper or con-
tainer, if it is a part of the package as
customarily distributed or sold.
(ii) Tank cars and other bulk con-
tainers—(A) Transportation. While a
pesticide product is in transit, the ap-
propriate provisions of 49 CFR Parts
170-189, concerning the transportation
of hazardous materials, and specifical-
ly those provisions concerning the la-
beling, marking and placarding of haz-
ardous materials and the vehicles car-
rying them, define the basic Federal
requirements. In addition, when any
registered pesticide product is trans-
ported in a tank car, tank truck or
other mobile or portable bulk contain-
er, a copy of the accepted label must
be attached to the shipping papers,
and left with the consignee at the time
of delivery.
(B) Storage. When pesticide prod-
ucts are stored in bulk containers,
whether mobile or stationary, which
remain in the custody of the user, a
copy of the label of labeling, including
all appropriate directions for use, shall
be securely attached to the container
in the immediate vicinity of the dis-
charge control valve.
(5) False or misleading statements.
Pursuant to section 2(q)(lXA) of the
Act, a pesticide or a device declared
subject to the Act pursuant to
i 153.240. is misbranded if its labeling
is false or misleading in any particular
including both pesticidal and non-pes-
ticidal claims. Examples of statements
or representations in the labeling
which constitute misbranding include:
(i) A false or misleading statement
concerning the composition of the
product;
76
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Protection Agoncy
A fcl&e or misleading statement
-incerning the effectiveness of the
ijoduct as a pesticide or device;
(iii) A false or misleading statement
about the value of the product for
purposes other than as a pesticide or
device;
(tv) A false or misleading comparison
^ith other pesticides or devices;
(v) Any statement directly or indi-
rectly implying that the pesticide or
device is recommended or endorsed by
any agency of the Federal Govern-
ment;
(vi) The name of a pesticide which
contains two or more principal active
Ingredients if the name suggests one
or more but not all such principal
active ingredients even though the
names of the other ingredients are
stated elsewhere in the labeling;
(vii) A true statement used in such a
way as to give a false or misleading im-
pression to the purchaser;
(viii) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions;
-------
§156.10

tent of the packages in a shipment faU
below the stated average content.
No.
set in type of a

SfwhSfit wp*A • «d shaU run par-
onwmcn»i»t^ registration number
and style similar to
. ^1^ *ot tne i&bel
*
4Q CFR Ch. I (7-1-89 Edition)

the label. If there is an outside con-
tainer or wrapper through which the
ingredient statement cannot be clearly
-------
Protection Agency
in cases where it Is determined
» pesticide formulation changes
composition significantly,
must bear the following
» t*ment in a prominent position on
£e label: "Not for sale or use after
product must meet all label
up to the expiration time indi-
!*ter. on the label.
(7 Inert ingredients. The Adminis-
trator may require the name of any
me -I ingredient(s) to be listed in the
Ingredient statement if he determines
tSit such ingredients) may pose a
hazard to man or the environment.
(h) W&:~*n?3 and precautionary
statement*. Required warnings and
precautionary statements concerning
§ 156.10

the general areas of lexicological
hazard including hazard to children.
environmental hazard, and physical or
chemical hazard fall into two groups;
those required on the front panel of
the labeling and those which may
appear elsewhere. Specific require-
ments concerning content, placement,
type size, and prominence are given
below.
(1) Required front'panel statements.
With the exception of the child
hazard warning statement, the text re-
quired on the front panel of the label
is determined by the Toxicity Catego-
ry of the pesticide. The category is as-
signed on the basis of the highest
hazard shown by any of the indicators
in the table below:
mart todcator*
Oral ID,,....:.-—-

initiation LCM- ....
"*
1)< Human hazard signal word—
-------
§

that it is approved for use on infants
or small children, may the Administra-
tor waive this requirement.
(lii) Statement of practical treat-
ment— Toxicity Category I. A
statement of practical treatment (first
aid or other) shall appear on the front
panel of the label of aH pesticides fall-
ing into Toxicity Category I on the
basis of oral, inhalation or dermal tox-
icity. The Agency may, however,
permit reasonable variations in the
placement of the statement of practi-
cal treatment is some reference such
as "See statement of practical treat-
ment on back panel" appears on the
front panel near the word "Poison"
»na I/""" skull and crossbones.
10 ,„„. .„.„„.„...„„-„,„„'...
Above 10*9 i? ,-.,„;,.,„„„„„„„„„„
Aftovt'18'lo 90.; ...... ,. .-. ...i ..........
Of 90 - - .,

Points
Required
signal
word, cfl
capitals
S
10
12
14
18
"Keapouj
of reach*
chiiorert"
e
«
i
10
18
(2) Other required warnings and pre-
cautionary statements. The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the general heading
"Precautionary Statements" and
under appropriate subheadings of
"Hazard to Humans and Domestic Ani-
mals," "Environmental Hazard" and
jUPhysieal or Chemical Hazard."
(i) Hazard to humans and domestic
animals. (A) Where a hazard exists to
humans or domestic animals, precau-
tionary statements are required indi-
cating the particular hazard, the
route(s) of exposure and the precau-
tions to be taken to avoid accident,
injury or damage. The precautionary
paragraph shall be immediately pre-
ceded by the appropriate hazard signal
word.
(B) The following table depicts typi-
cal precautionary statements. These
statements must be modified or ex-
panded to reflect specific hazards.
Toxicity
category
Precautionary statement* by towaty category
Oral, inhaMon, or dermal tadctty
Skin and eye local effects
HI.
IV.
Fatal (poitonoua) * swallowed [inhaled or absorbed
through skin]. Do not breathe vapor [oust or spray
mist]. Do not get in eyes, on skin, or on clothing
[Front panel statement of practical treatment re-
quired.].
May be fatal W awatewsd [inhaled or absorbed
through the skin]. Do not breathe vapors [dust or
spray mistl. Do not get in eyes, on skin, or on
clothing. [Appropriate first aid statements required.].
Harmful tf swallowed [inhaled or absorbed through the
skin]. Avoid breathing vapors [dust or spray mist].
Avoid contact with akin [eyoe or clothing]. [Appro-
priate first aid statement required.].
[No precautionary statements
Corrosive, causes eye and skin damage [or akin
irritation]. Do not get in eyes, on akin, or on
etothmg. Wear goggles or face shield and rubber
gloves when handling. Harmful or fatal H swallowed.
[Appropriate first aid statement required.]
Causes eye [and skin] irritation. Do not get in eyes,
on skin, or on clothing. Harmful M swallowed. [Ap-
propriate first aid statement required.]
Avoid contact with skin, eyes or clothing. In case of
contact immediately flush eyes or skin wsth plenty of
water. Get medical attention V irritation persists.

[No precautionary statements required.]
80
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«*
.trjnp**"111" riwiw»»»w«» Aj*ncy

rntrfronm^ntaJ /Uuronfj. Where a
exists to non target organisms
Tg humans and domestic ani-
^ecautionary statements are re-
stating the nature of the
and the appropriate precau-
to avoid potential accident,
or damage. Examples of the
•tatements and thf circum-
under which they ar. required
a pesticide intended for out-
use contains an active Ingredient
* mammalian acute oral LDM of
r less, the statement "This Pesti-
« is Toxic to Wildlife" Is required.
(B) H a pesticide intended for out
door use contains an active Ingredient
frith a fish acute LCM of 1 ppm or less,
thestatement "This Pesticide is Toxic
to Fish" is required.
(C) If & pesticide Intended for out-
door use contains an active ingredient
^th an avian acute oral LDM of 100
to«/kE or less, or e, subacute dietary
§ 156.10

LCM of 500 ppm or less, the statement
"This Pesticide is Toxic to Wildlife" Is
required.
(D) If either accident history or field
studies demonstrate that use of the
pesticide may result In fatality to
birds, fish or mammals, the statement
"This pesticide is extremely toxic to
wildlife (fish)" Is required.
(E) For uses involving foliar applica-
tion to agricultural crops, forests, or
shade trees, or for mosquito abate-
ment treatments, pesticides toxic to
pollinating insects must bear appropri-
ate label cautions. .
(F) For all outdoor uses other than
aquatic applications the label must
bear the caution "Keep out of lakes,
ponds or streams. Do not contaminate
water by cleaning of equipment or dis-
posal of wastes."
(iii) Physical or chemical hazards.
Warning statements on the flammabil-
ity or explosive characteristics of the
pesticide are required as follows:
Flash point
Required text
(A) PRESSURIZED
point at or betow 20* F; H there is a flashback at
«ny vstve opening.
pcxr.t above 20* F and not ever 80' F or If the
ne extension « more than 18 in long at a distance
of 6 in from the flame.
AI other pressurized containers.
Extremely flammable. Contents under pressure. Keep away from
fire, sparfcs. and heated surfaces. 06 not puncture or incinerate
container. Exposure to temperatures above 130* F may cause
bursting.
RammaWe. Contents under pressure. Kee$> ewey from heat,
•parks, and open flame. Do not puncture or incinerate container.
Exposure to temperatures above 130* F may cause bursting.
Contents under pressure. Do not use or store near heat or open
flame. Do not puncture or incinerate container. Exposure to
temperatures above 130* F may cause bursting.
(B) NONPftESSUfllZCD CONTWNCTS
Al or bttow 20* F.
Above 20* F and not over 80' F
Above 60* F and not over 150* f.
Extremely flammable. Keep away from fire, sparks, and heated
° surfaces.
Flammable. Keep away from neat and open flame.
Do not use or store near heat or open flame.
(i) Directions for Use—01) General
requirements—-------
£156.10

(B) The label bears t reference to
the directions for use In accompanying
leaflets or circulars, such as "See di-
rections in the enclosed circular" and
(C) The Administrator determines
that it is not necessary for such direc-
tions to appear on the label.
(ill) Exceptions to requirement for
direction for use—(A) Detailed direc-
tions for use may be ooaitted from la-
beling of pesticides wr* «ch are intended
for use only by manuf icturers of prod-
ucts other than pest.cide products in
their regular manufacturing processes,
provided that:
U) The label clearly shows that (he
product is intended for uc* only in
manufacturing processes and s^ocifies
the type(s) of products involved.
(2) Adequate information such as
technical data sheets or bulletins, is
available to the trade specifying the
type of product involved and its
proper use in manufacturing process-
es;
<3) The product will not come into
the hands of the general public except
after incorporation into finished prod-
ucts; and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment,
(B) Detailed directions for use may
be omitted from the labeling of pesti-
cide products for which sale is limited
to physicians, veterinarians, or drug-
gists, provided that:
U) The label clearly states that the
product is for use only by physicians
or veterinarians;
(2) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment; and
(3) The product is also a drug and
regulated under the provisions of the
Federal Food, Drug and Cosmetic Act.
(C) Detailed directions for use may
be omitted from the labeling of pesti-
cide products which are intended for
use only by formulators in preparing
pesticides for sale to the public, pro-
vided that:
«) There is information readily
available to the formulators on the
composition, toxicity, methods of use,
applicable restrictions or limitations,
40 CFR Ch. I (7-1-Sf Edition)

and effectiveness of the product for
pesticide purposes;
<2> The label clearly states that the
product is intended for use only in
manufacturing, formulating, mixing,
or repacking for use as a pesticide and
specifies the type(s) of pesticide prod-
ucts involved;
<£> The product as finally manufac-
tured, formulated, mixed, or repack-
aged is registered; and
«) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(2) Contents of Directions for Use.
The directions for use shall include
the following, under the headings "Di-
rections for Use":
(i) The statement of use classifica-
tion as prescribed in paragraph (j) of
this section immediately under the
heading "Directions for Use."
(il) Immediately below the state-
ment of use classification, the state-
ment "It is a violation of Federal law
to use this product in a manner incon-
sistent with its labeling."
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Protection Agoncy
. Any limitations or restrictions on
reauired to prevent unreasonable
e effects, such as:
Required intervals between ap-
harvest of food or feed
) Rotational crop restrictions.
/C) Warnings as required against use
n certain crops, animals, objects, or
fn or adjacent to certain areas.
[Reserved]
(E) For restricted use pesticides, a
mtatement that the pesticide may be
*ot>Ued under the direct supervision of
t Certified applicator who is not phys-
J*«Tly present at the site of application
but nonetheless available to the
oerson applying the pesticide, unless
the Agency has determined that the
Desticide may only be applied under
the direct supervision of a certified ap-
plicator who is physically present.
OF) Other pertinent Information
which the Administrator determines
to be necessary for the protection of
yuan and the environment.
statement of Use Classification.
By October 22, 1976, all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
In paragraphs (j) (1) and (2) of this
section. Any pesticide product for
which some uses are classified for gen-
eral use and others for restricted use
shall be separately labeled according
to the labeling standards set forth in
this subsection, and shall be marketed
as separate products with different
registration numbers, one bearing di-
rections only for general use(s) and
the other bearing directions for re-
stricted use
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-------
Appendix F
Generic and Product-Specific Data Call-In
-------
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460
GENERIC AND PRODUCT SPECIFIC
DATA CALL-IN NOTICE

FEB I 6 £94
OFFICE OF
PREVENTION. PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Sir or Madam:

This Notice requires you and other registrants of pesticide
products containing the active ingredient identified in
Attachment A of this Notice, the Data Call-in Chemical Status
Sheet r to submit certain data as noted herein to the U.S.
Environmental Protection Agency (EPA, the Agency) . These data are
necessary to maintain the continued registration of your
product (s) containing this active ingredient. Within 90 days
after you receive this Notice you must respond as set forth in
III below. Your response must state:

How you will comply with the requirements set forth in
this Notice and its Attachments 1 through 7; or

Why you believe you are exempt from the requirements
listed in this Notice and in Attachment 3 (for both
generic and product specific data) , the Requirements
Status and Registrant's Response Form, (see section
III-B) ; or

Why you believe EPA should not require your submission
of data in the manner specified by this Notice (see
section III-D) .
1.
2.
3.
If you do not respond to this Notice, or if you do not
satisfy EPA that you will comply with its requirements or should
be exempt or excused from doing so, then the registration of your
product (s) subject to this Notice will be subject to suspension.
We have provided a list of all of your products subject to this
Notice in Attachment 2. All products are listed on both the
generic and product specific Data Call-in Response Forms. Also
included is a list of all registrants who were sent this Notice
(Attachment 6) .

The authority for this Notice is section 3(c)(2)(B) of the
Federal Insecticide, Fungicide and Rodenticide Act as amended
(FIFRA) , 7 U.S.C. section 136a(c) (2) (B) . Collection of this
-------
information is authorized under the Paperwork Reduction Act by
OMB Approval No. 2070-0107 and 2070-0057 (expiration date
3-31-96).

This Notice is divided into six sections and seven
Attachments. The Notice itself contains information and
instructions applicable to all Data Call-in Notices. The
Attachments contain specific chemical information and
instructions. The six sections of the Notice are:
Section I
Section II
Section III
Ssction IV

Section V

Section VI
Why You are Receiving this Notice
Data Required by this Notice
Compliance with Requirements of this Notice
Consequences of Failure to Comply with this
Notice
Registrants' Obligation to Report Possible
Unreasonable Adverse Effects
Inquiries and Responses to this Notice
The Attachments to this Notice are:

'•"!•- Data Call-In Chemical Status Sheet
2 ~ Generic Data Call-In and Product Specific Data
Call-In Response Forms with Instructions
3 OT Generic Data Call-In and Product Specific Data
Call-In Requirements Status and Registrant's
Response Forms with Instructions
4 ~ EPA Grouping of End-Use Products for Meeting Acute
Toxicology Data Requirements for Rereaistration
5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms

SECTION I. WHY YOU ARE RECEIVING THIS NOTICE

The Agency has reviewed existing data for this active
ingredient(s) and reevaluated the data needed to support
continued registration of the subject active ingredient(s). This
reevaluation identified additional data necessary to assess the
health and safety of the continued use of products containing
this active ingredient(s). You have been sent this Notice because
you have product(s) containing the subject active ingredients.
SECTION II. DATA REQUIRED BY THIS NOTICB

II-A. DATA REQUIRED

The data required by this Notice are specified in the
Requirements Status and Registrant's Response Forms! Attachment 3
-------
(for both generic and product specific data requirements).
Depending on the results of the studies required in this Notice,
additional studies/testing may be required.
II-B. SCHEDULE FOR SUBMISSION OF DATA

You are required to submit the data or otherwise satisfy the
data requirements specified in the Requirements Status and
Registrant's Response Forms (Attachment 3) within the timeframes
provided.

II-C* TESTING PROTOCOL

All studies required under this Notice must be conducted in
accordance with test standards outlined in the Pesticide
Assessment Guidelines for those studies for which guidelines have
been established.

These EPA Guidelines are available from the National
Technical Information Service (NTIS), Attn: Order Desk, 5285 Port
Royal Road, Springfield, Va 22161 (Telephone number:
70T-'V87~4650) ,

Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if the
OECD recommended test standards conform to those specified in the
Pesticide Data Requirements regulation (40 CFR § 158.70). When
using the OECD protocols, they should be modified as appropriate
so that the data generated by the study will satisfy the
requirements of 40 CFR § 158. Normally, the Agency will not
extend deadlines for complying with data requirements when the
studies were not conducted in accordance with acceptable
standards. The OECD protocols are available from OECD, 2001 L
Street, N.W., Washington, D.C. 20036 (Telephone number 202-785-
6323; Fax telephone number 202-785-0350).

All new studies and proposed protocols submitted in response
to this Data Call-in Notice must be in accordance with Good
Laboratory Practices [40 CFR Part 160].
II-D.
REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(E)
NOTICES ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-in does not in
any way supersede or change the requirements of any previous Data
Call-InfsV. or any other agreements entered into with the Agency
pertaining to such prior Notice. Registrants must comply with the
requirements of all Notices to avoid issuance of a Notice of
Intent to Suspend their affected products.
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SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE

You must use the correct forms and instructions when
completing your response to this Notice. The type of Data
Call-in you must comply with (Generic or Product Specific) is
specified in item number 3 on the four Data Call-In forms
(Attachments 2 and 3).

III-A. SCHEDULE FOR RESPONDING TO THE AGENCY

The appropriate responses initially required by this Notice
for generic and product specific data must be submitted to the
Agency within 90 days after your receipt of this Notice, Failure
to adequately respond to this Notice within 90 days of your
receipt will be a basis for issuing a Notice of Intent to Suspend
(NOIS) affecting your products. This and other bases for issuance
of NOIS due to failure to comply with this Notice are presented
in Section IV-A and IV-B.

III-B. OPTIONS FOR RESPONDING TO THE AGENCY

1. Generic Data Requirements

The options for responding to this Notice for generic data
requirements ares (a) voluntary cancellation, (b) delete use(s),
(c) claim generic data exemption, (d) agree to satisfy the
cjeneric data requirements imposed by this Notice or (e) request a
data wa.iver(s) .

A discussion of how to respond if you choose the Voluntary
Cancellation option, the Delete Use(s) option or the Generic Data
Exemption option is presented below. A discussion of the various
options available for satisfying the generic data requirements of
this Notice is contained in Section III-C. A discussion of
options relating to requests for data waivers is contained in
Section III-D.

Two forms apply to generic data requirements, one or both of
which must be used in responding to the Agency, depending upon
your response. These two forms are the Data-Call-in Response
Form, and the Requirements Status and Registrant's Response Formf
(contained in Attachments 2 and 3, respectively).

The Data Call-in Response Forms must be submitted as part of
every response to this Notice. The Requirements Status and
Registrant's Response Forms also must be submitted if you do not
qualify for a Generic Data Exemption or are not requesting
voluntary cancellation of your registration(s). Please note that
the company's authorized representative is required to sign the
first page of both Data Call-in Response Forms and the
Requirements Status and Registrant's Response Forms (if this form
-------
is required) and initial any subsequent pages. The forms contain
separate detailed instructions on the response options. Do not
alter the printed material. If you have questions or need
assistance in preparing your response, call or write the contact
person (s) identified in Attachment 1.

a. Voluntary Cancellation -.

You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product (s) containing the active
ingredient that is the subject of this Notice. If you wish to
voluntarily cancel your product, you must submit completed
Generic and Product Specific Data Call-In Response Forms
(Attachment 2) , indicating your election of this option.
Voluntary cancellation is item number 5 on both Data Call-In
Response Form (s) . If you choose this option, these are the only
forms that you are required to complete.

If you chose to voluntarily cancel your product, further
sale and distribution of your product after 'the effective date of
cancellation must be in accordance with the Existing Stocks
provisions of this Notice, which are contained in Section IV-C.
i*ou may avoid the requirements of this Notice by eliminating
t'na ut'es of your product to which the requirements apply. If you
wish to amend your registration to delete uses, you must submit
the Requirements Status and Registrant's Response Fora
(Attachment 3) , a completed application for amendment, a copy of
your proposed amended labeling, and all other information
required for processing the application. Use deletion is option
number 7 under item 9 in the instructions for the Requirements
Status and Registrant's Response Forms. You must also complete a
Data Call-In Response Form by signing the certification, item
number 8. Application forms for amending registrations may be
obtained from the Registration Support Branch, Registration
Division, Office of Pesticide Programs, EPA, by calling (703)
308-8358.

If you choose to delete the use(s) subject to this Notice or
uses subject to specific data requirements, further sale,
distribution, or use of your product after one year from the due
date of your 90 day response, is allowed only if the product
bears an amended label.

c. Generic Data Exemption -

Under section 3(c)(2)(D) of FIFRA, an applicant for
registration of a product is exempt from the requirement to
submit or cite generic data concerning an active ingredient if
the active ingredient in the product is derived exclusively from
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purchased/ registered pesticide products containing the active
ingredient. EPA has concluded, as an exercise of its discretion,
that it normally will not suspend the registration of a product
which would qualify and continue to qualify for the generic data
exemption in section 3(c)(2)(D) of FIFRA. To qualify, all of the
following requirements must be met:

(i). The active ingredient in your registered product must
be present solely because of incorporation of another
registered product which contains the subject active
ingredient and is purchased from a source not connected with
you i

(ii). Every registrant who is the ultimate source of the
active ingredient in your product subject to this DCI must
be in compliance with the requirements of this Notice and
must remain in compliance; and

(iii). You must have provided to EPA an accurate and
current "Confidential Statement of Formula" for each of your
products to which this Notice applies.

To apply for the Generic Data Exemption you must submit a
completed Data Call-In Response Form., Attachment 2 and all
supporting documentation. The Generic Data Exemption is item
number 6a on the Data Call-in Response Form. If you claim a
generic data exemption you are not required to complete the
Requirements Status and Registrant's Response Form. Generic Data
Exemption cannot be selected as an option for responding to
product specific data requirements.

If you are granted a Generic Data Exemption, you rely on the
efforts of other persons to provide the Agency with the required
data. If the registrant(s) who have committed to generate and
submit the required data fail to take appropriate steps to meet
requirements or are no longer in compliance with this Data Call-
in Notice, the Agency will consider that both they and you are
not compliance and will normally initiate proceedings to suspend
the registrations of both your and their product(s), unless you
commit to submit and do submit the required data within the
specified time. In such cases the Agency generally will not grant
a time extension for submitting the data.

d. Satisfying the Generic Data Requirements of this Notice

There are various options available to satisfy the generic
data requirements of this Notice. These options are discussed in
Section III-C.l. of this Notice and comprise options 1 through 6
of item 9 in the instructions for the Requirements Status and
Registrant's Response Form and item 6b on the Data Call-in
Response Form. If you choose item 6b (agree to satisfy the
-------
generic data requirements), you must submit the Data Call-In
Response Form and the Requirements status and Registrant's
Response Form as well as any other information/data pertaining to
the option chosen to address the data requirement. Your response
must be on the forms marked "GENERIC" in item number 3.

e. Request for Generic Data Waivers.

Waivers for generic data are discussed in Section III-D.l.
of this Notice and are covered by options 8 and 9 of item 9 in
the instructions for the Requirements Status and Registrant's
Response Form. If you choose one of these options, you must
submit both forms as well as any other information/data
pertaining to the option chosen to address the data requirement.
2. Product Specific Data Requirements

The options for responding to this Notice for product
specific data are: (a) voluntary cancellation, (b) agree to
satisfy the product specific data requirements imposed by this
Notice or (c) request a data waiver(s),

A discussion of how to respond if you choose the Voluntary
Cancellation option is presented below. A discussion of the
various options available for satisfying the product specific
data requirements of this Notice is contained in Section III-C.2.
A discussion of options relating to requests for data waivers is
contained in Section III-D.2.

Two forms apply to the product specific data requirements
one or both of which must be used in responding to the Agency,
depending upon your response. These forms are the Data-Call-in
Response Form, and the Requirements status and Registrant's
Response Form, for product specific data (contained in
Attachments 2 and 3, respectively). The Data Call-In Response
Form must be submitted as part of every response to this Notice.
In addition, one copy of the Requirements Status and Registrant's
Response Form also must be submitted for each product listed on
the Data Call-in Response Form unless the voluntary cancellation
option is selected. Please note that the company's authorized
representative is required to sign the first page of the Data
Call-in Response Form and Requirements Status and Registrant's
Response Form (if this form is required) and initial any
subsequent pages. The forms contain separate detailed
instructions on the response options. Do not alter the printed
material. If you have questions or need assistance in preparing
your response, call or write the contact person(s) identified in
Attachment 1.

a. Voluntary cancellation
-------
You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active
ingredient that is the subject of this Notice. If you wish to
voluntarily cancel your product, you must submit a completed Data
Call-in Response Form, indicating your election of this option.
Voluntary cancellation is item number 5 on both the Generic and
Product Specific Data Call-In Response Forms,. If you choose this
option, you must complete both Data Call-In response forms.
These are the only forms that you are required to complete.

If you choose to voluntarily cancel your product, further
sale and distribution of your product after the effective date of
cancellation must bs in accordance with the Existing Stocks
provisions of this Fotic© which are contained in Section IV-C.
b. Satisfying the Product Specific Data Requirements of
this Notice.

There are various options available to satisfy the product
specific data requirements of this Notice. These options are
discussed in Section III-C.2. of this Notice and comprise options
1 through 6 of item 9 in the instructions for the product
specific Requirements Status and Registrant's Response Form and
item numbers 7a and 7b (agree to satisfy the product specific
data requirements for an MUP or EUP as applicable) on the product
specific Data Call-in Response Form. Note that the options
available for addressing product specific data requirements
differ slightly from those options for fulfilling generic data
requirements. Deletion of a use(s) and the low volume/minor use
option are not valid options for fulfilling product specific data
requirements. It is important tp ensure that you are using the
correct forms and instructions when completing your response to
the Reregistration Eligibility Decision document.

c. Request for Product Specific Data Waivers.

Waivers for product specific data are discussed in Section
III-D.2. of this Notice and are covered by option 7 of item 9 in
the instructions for the Requirements Status and Registrant's
Response Form. If you choose this option, you must submit the
Data Call-in Response Form and the Requirements Status and
Registrant's Response Form as well as any other information/data
pertaining to the option chosen to address the data requirement.
Your response must be on the forms marked "PRODUCT SPECIFIC" in
item number 3.

III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
8
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1. Generic Data

If you acknowledge on the Generic Data Call-In Response Form
that you agree to satisfy the generic data requirements (i.e. you
select item number 6b), then you must select one of the six
options on the Generic Requirements Status and Registrant's
Response Form related to data production for each data
requirement. Your option selection should be entered under item
number 9, "Registrant Response." The six options related to data
production are the first six options discussed under item 9 in
the instructions for completing the Requirements Status and
Registrant's Response Form. These six options are listed
immediately below with information in parentheses to guide you to
additional instructions provided in this Section. The options
are? -

(1) I will generate and submit data within the specified
timeframe (Developing Data)
(2) I have entered into an agreement with one or more
registrants to develop data jointly (Cost Sharing)

(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been
submitted previously to the Agency by anyone
(Submitting an Existing Study)
(5) 1 am submitting or citing data to upgrade a study
classified by EPA as partially acceptable and
upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified
as acceptable or an existing study that has been
submitted but not reviewed by the Agency (Citing an
Existing Study)

Option l. Developing Data

If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency
requirements as referenced herein and in the attachments. All
data generated and submitted must comply with the Good Laboratory
Practice (GLP) rule (40 CFR Part 160), be conducted according to
the Pesticide Assessment Guidelines (PAG) and be in conformance
with the requirements of PR Notice 86-5. In addition, certain
studies require Agency approval of test protocols in advance of
study initiation. Those studies for which a protocol must be
submitted have been identified in the Requirements Status and
Registrant's Response Form and/or footnotes to the form. If you
wish to use a protocol which differs from the options discussed
in Section II-C of this Notice, you must submit a detailed
description of the proposed protocol and your reason for wishing
to use it. The Agency may choose to reject a protocol not
specified in Section II-C. If the Agency rejects your protocol
you will be notified in writing, however, you should be aware
-------
that rejection of a proposed protocol will not be a basis for
extending the deadline for submission of data.

A progress report must be submitted for each study within 90
days from the date you are required to commit to generate or
undertake some other means to address that study requirement,
such as making an offer to cost share or agreeing to share in the
cost of developing that study. This 90-day progress report must
include the date the study was or will be initiated and, for
studies to be started within 12 months of commitment, the name
and address of the laboratory(ies) or individuals who are or will
be conducting the study.

In addition, if the time frame for submission of a final
report is more than 1 year, interim reports must b@ submitted at
12 month intervals from the date you are required to commit to
generate or otherwise address the requirement for the study. In
addition to the other information specified in the preceding
paragraph, at a minimum, a brief description of current activity
on and the status of the study must be included as well as a full
description of any problems encountered since the last progress
report.
The time frames in the Requirements Status and Registrant's
Response Form are the time frames that the Agency is allowing for
the submission of completed study reports or protocols. The noted
deadlines run from the date of the receipt of this Notice by the
registrant. If the data are not submitted by the deadline, each
registrant is subject to receipt of a Notice of Intent to Suspend
the affected registration(s). • '

If you cannot submit the data/reports to the Agency in the
time required by this Notice and intend to seek additional time
to meet the requirements(s), you must submit a request to the
Agency which includes: (1) a detailed description of the expected
difficulty and (2) a proposed schedule including alternative
dates for meeting such requirements on a step-by-step basis. You
must explain any technical or laboratory difficulties and provide
documentation from the laboratory performing the testing. While
EPA is considering your request, the original deadline remains.
The Agency will respond to your request in writing. If EPA does
not grant your request, the original deadline remains. Normally,
extensions can be requessted only in cases of extraordinary
testing problems beyond the expectation or control of the
registrant. Extensions will not be given in submitting the 90-day
responses. Extensions will not be considered if the request for
extension is not made in a timely fashion; in no event shall an
extension request be considered if it is submitted at or after
the lapse of the subject deadline.

Option 2. Agreement to Share in Cost to Develop Data

10
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If you choose to enter into an agreement to share in the
cost of producing the required data but will not be submitting
the data yourself, you must provide the name of the registrant
who will be submitting the data. You must also provide EPA with
documentary evidence that an agreement has been formed. Such
evidence may be your letter offering to join in an agreement and
the other registrant's acceptance of your offer, or a written
statement by the parties that an agreement exists. The agreement
to produce the data need not specify all of the terms of the
final arrangement between the parties or the mechanism to resolve
the terms. Section 3(c)(2)(B) provides that if the parties cannot
resolve the terms of the agreement they may resolve their
•,\if fetrmces through binding arbitration.

QRtiojX-^i-*- Offer to Share in the Cost of Data Development

If you have made an offer to pay in an attempt to enter into
an agreement or amend an existing agreement to meet the
requirements of this Notice and' have been unsuccessful, you may
request EPA (by selecting this option) to exercise its discretion
not to suspend your registration(s), although you do not comply
with the data submission requirements of this Notice. EPA has
determined that as a general policy, absent other relevant
considerations, it will not suspend the registration of a product

nf. a registrant who has in good faith sought and continues to
seek ":o enter into a joint data development/cost sharing program,
but bh<2 other registrant(s) developing the data has refused to
accept the offer. To qualify for this option, you must submit
documentation to the Agency proving that you have made an offer
to another registrant (who has an obligation to submit data) to
share in the burden of developing that data. You must also submit
to the Agency a completed EPA Form 8570-32, Certification of
Offer to Cost Share in the Development of Data, Attachment 7. In
addition, you must demonstrate that the other registrant to whom
the offer was made has not accepted your offer to enter into a
cost-sharing agreement by including a copy of your offer and
proof of the other registrant's receipt of that offer (such as a
certified mail receipt). Your offer must, in addition to anything
else, offer to share in the burden of producing the data upon
terms to be agreed to or, failing agreement, to be bound by
binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii)
and must not qualify this offer. The other registrant must also
inform EPA of its election of an option to develop and submit the
data required by this Notice by submitting a Data Call-in
Response Form and a Requirements Status and Registrant's Response
Form committing to develop and submit the data required by this
Notice.

In order for you to avoid suspension under this option, you
may not withdraw your offer to share in the burden of developing
the data. In addition, the other registrant must fulfill its

11
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commitment to develop and submit the data as -required by this
Notice, If the other registrant fails to develop the data or for
some other reason is subject to suspension, your registration as
well as that of the other registrant normally will be subject to
initiation of suspension proceedings, unless you commit to
submit, and do submit, the required data in the specified time
frame, In such cases, the Agency generally will not grant a time
extension for submitting the data,

Option 4. Submitting an Existing Study

If you choose to submit an existing study in response to
this Notice, you must determine that the study satisfies the
requirements imposed by this Notice, You may only submit a study
that has not been previously submitted to the Agency or
previously cited by anyone. Existing studies are studies which
predate issuance of this Notice. Do not use this option if you
are submitting data to upgrade a study. (See Option 5).

You should be aware that if the Agency determines that the
study is not acceptable, the Agency will require you to comply
with this Notice, normally without an extension of the required
date of submission. The Agency may determine at any time that a
study is not valid and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an
existing study, all of the following three criteria must be
clearly Met:
a.
You must certify at the time that the existing study is
submitted that the raw data and specimens from the
study are available for audit and review and you must
identify where they are available. This must be done in
accordance with the requirements of the Good Laboratory
Practice (GLP) regulation, 40 CFR Part 160. As stated
in 40 CFR 160.3 "*[r]aw data' means any laboratory
worksheets, records, memoranda, notes, or exact copies
thereof, that are the result of original observations
and activities of a study and are necessary for the
reconstruction and evaluation of the report of that
study. In the event that exact transcripts of raw data
have been prepared (e.g., tapes which have been
transcribed verbatim, dated, and verified accurate by
signature), the exact copy or exact transcript may be
substituted for the original source as raw data. 'Raw
data1 may include photographs, microfilm or microfiche
copies, computer printouts, magnetic media, including
dictated observations, and recorded data from automated
instruments." The term "specimens'9, according to 40 CFR

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160.3, means "any material derived from a test system
for examination or analysis."

b. Health and safety studies completed after May 1984 also
must also contain all GLP-required quality assurance
and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants also must
certify at the time of submitting the existing study
that such GLP information is available for post May
1984 studies by including an appropriate statement on
or attached to the study signed by an authorized.
official or representative of the registrant.

c. You must certify that each study fulfills the
acceptance criteria for the Guideline relevant to the
study provided in the FIFRA Accelerated Reregistration
Phase 3 Technical Guidance and that the study has been
conducted according to the Pesticide Assessment
Guidelines (PAG) or meets the purpose of the PAG (both
available from NTIS). A study not conducted according
to the PAG may be submitted to the Agency for
consideration if the registrant believes that the study
clearly meets the purpose of the PAG. The registrant is
referred to 40 CFR 158.70 which states the Agency's
policy regarding acceptable protocols. If you wish to
submit the study, you must, in addition to certifying
that the purposes of the PAG are met by the study,
clearly articulate the rationale why you believe the
study meets the purpose of the PAG, including copies of
any supporting .information or data. It has been the
Agency's experience that studies completed prior to
January 1970 rarely satisfied the purpose of the PAG
and that necessary raw data usually are not available
for such studies.

If you submit an existing study, you must certify that the
study meets all requirements of the criteria outlined above.

If EPA has previously reviewed a protocol for a study you
are submitting, you must identify any action taken by the Agency
on the protocol and must indicate, as part of your certification,
the manner in which all Agency comments, concerns, or issues were
addressed in the final protocol and study.

If you know of a study pertaining to any requirement in this
Notice which does not meet the criteria outlined above but does
contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such
study is in the Agency's files, you need only cite it along with
the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.
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Option 5. Upgrading a

If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The
Agency will review the data submitted and determine if the
requirement is satisfied. If the Agency decides the requirement
is not satisfied, you may still be required to submit new data
normally without any time extension. Deficient, but upgradeable
studies will normally be classified as supplemental. However, it
is important to note that not all studies classified as
supplemental are upgradeable. If you have questions regarding the
classification of a study or whether a study may be upgraded,
call or write the contact person listed in Attachment 1. If you
submit data to upgrade an existing study you must satisfy or
supply .-information to correct all deficiencies in the study .
identified by.EPA. You must provide a clearly articulated
rationale of how the deficiencies have been remedied or corrected
and why the study should be rated as acceptable to EPA. Your
submission must also specify the MRID number(s) of the study
which you are attempting to upgrade and must be in conformance
with PR Notice 86-5.

Do not submit additional data for the purpose of upgrading a
study classified as unacceptable and determined by the Agency as
not capable of being upgraded.

This option also should be used to cite data that has been
previously submitted to upgrade a study, but has not yet been
reviewed by the Agency. You must provide the MRID number of the
data submission as well as the MRID number of the study being
upgraded.

The criteria for submitting an existing study, 'as specified
in Option 4 above, apply to all data submissions intended to
upgrade studies. Additionally, your submission of data intended

to upgrade studies must be accompanied by a certification that
you comply with each of those criteria, as well as a
certification regarding protocol compliance with Agency
requirements.

Option 6. Citing Existing Studies

If you choose to cite a study that has. been previously
submitted to EPA, that study must have been previously classified
by EPA as acceptable, or it must be a study which has not yet
been reviewed by the Agency. Acceptable toxicology studies
generally will have been classified as "core-guideline" or "core-
minimum." For ecological effects studies, the classification
generally would be a rating of "core." For all other disciplines
the classification would be "acceptable." with respect to any
studies for which you wish to select this option, you must
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provide the MRID number of the study you are citing and, if the
study has been reviewed by the Agency, you must provide the
Agency's classification of the study.

If you are citing a study of which you are not the original
data submitter, you must submit a completed copy of EPA Form
8570-31, Certification with Respect to Data Compensation
Requirements.

2. Product Specific Data

If you acknowledge on the product specific Data Call-in
Response Form that you agree to satisfy the product specific data
requirements (i.e. you select option 7a or 7b), then you must
select one of the six options on the Requirements status and
Registrant's Response Form related to data production for each
data requirement. Your option selection should be entered under
item number 9, "Registrant Response." The six options related to
data production are the first six options discussed under item 9
in the instructions for completing the Requirements status and
Registrant's Response Form. These six options are listed
immediately below with information in parentheses to guide
registrants to additional instructions provided in this Section.
The options are:

(1) X will generate and submit data within the specified
time-frame (Developing Data)
(2) I have entered into an agreement with one or more
registrants to develop data jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been
submitted previously to the Agency by anyone
(Submitting an Existing Study)

(5) I am submitting or citing data to upgrade a study
classified by EPA as partially acceptable and
upgradeable (Upgrading a study)

(6) I am citing an existing study that EPA has classified
as acceptable or an existing study that has been
submitted but not reviewed by the Agency (Citing an
Existing Study)

Option 1. Developing Data — The requirements for developing
product specific data are the same as those described for generic
data (see Section III.C.I, Option 1) except that normally no
protocols or progress reports are required.

Option 2. Agree to Share in Cost to Develop Data — If you enter
into an agreement to cost share, the same requirements apply to
product specific data as to generic data (see Section III.C.I,
Option 2). However, registrants may only choose this option for

15
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acute toxicity data and certain efficacy data and only if EPA has
indicated in the attached data tables that your product and at
least one other product are similar for purposes of depending on
the same data. If this is the case, data may be generated for
Dust one of the products in the group. The registration number of
the product for which data will be submitted must be noted in the
agreement to cost share by the registrant selecting this option.

Option 3. Offer to Share in the Cost of Data Development — The
same requirements for generic data (Section III. C.I. , Option 3)
apply to this option. This option only applies to acute toxicity
and certain efficacy data as described in option 2 above.
4 . Submitting an Existing Study — Th& same requirements
described for generic data (see Section jtli.C.l.1; Option 4) apply
to this option for product specific data.

Option 5. Upgrading a study — The same requirements described
for generic data (see Sectipn III.C.i.> Option 5) apply to this
option for product specific data. :,

Option 6. Citing Existing Studies— The saW T-gqiv^g.Tnor.j-o
described for generic data (see Section III.C. 1. , Option 6) apply
to this option for product specific data,

Registrants v/ho select one of the above 6 options must meet
all of the requirements described in the instructions for
completing the Data Call-In Response Form and the , Requirements
Status and Registrant ' s Response Form, and in the generic data
requirements section (III. C.I.)/ as appropriate.
III-D REQUESTS FOR DATA WAIVERS

1. Generic Data

There are two types of data waiver responses to this Notice.
The first is a request for a low volume/minor use waiver and the
second is.a waiver request based on your belief that the data
requirement(s) are not appropriate for your product.

a. Low Volume/Minor Use Waiver

Option 8 under item 9 on the Requirements Status and
Registrant's Response Form. Section 3(c)(2)(A) of FIFRA
requires EPA to consider the appropriateness of requiring
data for low volume, minor use pesticides. In implementing

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this provision, EPA considers low volume pesticides to be
only those active ingredients.whose total production volume
for all pesticide registrants is small. In determining
whether to grant a low volume, minor use waiver, the Agency
will consider the extent, pattern and volume of use, the
economic incentive to conduct the testing, the importance of
the pesticide, and the exposure and risk from use of the
pesticide. If an active ingredient is used for both high
volume and low volume uses, a low volume exemption will not
be approved. If all uses of an active ingredient are low
volume.and the combined volumes for all uses are also low,
then an exemption may be granted, depending on review of
other information outlined below. An exemption will not be
granted if any registrant of the active ingredient elects to
conduct the testing. Any registrant receiving a low volume
minor use waiver must remain within the sales figures in
their forecast supporting the waiver request in order to
remain qualified for such waiver. If granted a waiver, a
registrant will be required, as a condition of the waiver,
to submit annual sales reports. The Agency will respond to
requests for waivers in writing.

To apply for a low volume, minor use waiver, you must
submit the following information, as applicable to your
product(s), as part of your 90-day response to this Notice:

(i). Total company sales (pounds and dollars) of all
registered product(s) containing the active ingredient. If
applicable to the active ingredient, include foreign sales
for those products that are not registered in this country
but are applied to sugar (cane or beet), coffee, bananas,
cocoa, and other such crops. Present the above information
by year for each of the past five years.

(ii) Provide an estimate of the sales (pounds and
dollars) of the active ingredient for each major use site.
Present the above information by year for each of the past
five years.

fiii) Total direct production cost of product(s) ,
containing the active ingredient by year for the past five
vears. Include information on raw material cost, direct
labor cost, advertising, sales and marketing, and any other
significant costs listed separately.

(iv) Total indirect production cost (e.g; plant
overhead, amortized plant and equipment) charged to
product(s) containing the active ingredient by year for the
past five years. Exclude all non-recurring costs that were
directly related to the active ingredient, such as costs of
initial registration and any data development.
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(v) A list of each data requirement for which you seek
a waxver. Indicate the type of waiver sought and the
estimated cost to you (listed separately for each data
requirement and associated test) of conducting the testing
needed to fulfill each of these data requirements.

(vi) A list of each data requirement for which you are
not seeking any waiver and the estimated cost to you (listed
separately for each data requirement and associated test) of
conducting the testing needed to fulfill each of these data

(vii) For each of ths next ten years, a year-by-year
forecast of company sales (pounds and dollars) of the active
ingredient, direct production costs of product(s) containina
tne active ingredient (following the parameters in item 2
above), indirect production costs of product(s) containing
the active ingredient (following the parameters in item 3
above), and costs of data development pertaining to the
active ingredient.

(viii) A description of the importance and unique
benefits of the active ingredient to users. Discuss the use
patterns and the effectiveness of the active ingredient
relative to registered alternative chemicals and
non-chemical control strategies. Focus on benefits unique to
the active ingredient, providing information that is as
quantitative as possible, If you do not have quantitative
data upon which to base your estimates, then present the
reasoning used to derive your estimates. To assist the
Agency in determining the degree of importance of the active
ingredient in terms of its benefits, you should provide
information on any of the following factors, as applicable
to your product(s): (a) documentation of the usefulness of
the active ingredient in Integrated Pest Management, (b)
description of,the beneficial impacts on the environment of
use of the active ingredient, as opposed to its registered
alternatives, (c) information on the breakdown of the active
ingredient after use and on its persistence in the
environment, and (d) description of its usefulness against a
pest(s) of public health significance.

Failure to submit sufficient information for the Agency to
make a determination regarding a request for a low volume/minor
use waiver will result in denial of the request for a waiver.

b. Request for Waiver of Data

^ Option 9, under Item 9, on the Requirements Status and
Registrant's Response Fm-™. This option may be used if you
believe that a particular data requirement should not apply
because the requirement is inappropriate. You must submit a

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rationale explaining why you believe the data requirements
should not apply. You also must submit the current label(s)
of your product(s) and, if a current copy of your
Confidential Statement of Formula is not already on file you
must submit a current copy.

You will be informed of the Agency's decision in
writing. If the Agency determines that the data requirements
of this Notice are not appropriate to your product(s), you
will not be required to supply the data pursuant to section
3(c)(2)(B). If EPA determines that the data are required for
your productfs). you must choose a method of meeting the
requirements of this Notice within the time frame provided
by this Notice. Within 30 days of your receipt of the
Agency's written decision, you must submit a revised
Requirements Status and Registrant's Response Form
indicating the option chosen.

2. Product Specific Data

If you request a waiver for product specific data because
you believe it is inappropriate, you must attach a complete
justification for the request including technical reasons, data
and references to relevant EPA regulations, guidelines or
policies. (Notes any supplemental data must be submitted in the
format required by PR Notice 86-5). This will be the only.
opportunity to state the reasons or provide information in
support of your request. If the Agency approves your waiver
request, you will not be required to supply the data pursuant to
section 3(c)(2)(B) of FIFRA. If the Agency denies your waiver
request, you must choose an option for meeting the data
requirements of this Notice within 30 days of the receipt of the
Agency's decision. You must indicate and submit the option
chosen on the product specific Requirements Status and
Registrant's Response Form. Product specific data requirements
for product chemistry, acute toxicity and efficacy (where
appropriate) are required for all products and the Agency would
grant a waiver only under extraordinary circumstances. You should
also be aware that submitting a waiver request will no£
automatically extend the due date for the study in question.
Waiver requests submitted without adequate supporting rationale
will be denied and the original due date will remain in force.

SECTION IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE

IV-A NOTICE OF INTENT TO SUSPEND

The Agency may issue a Notice of Intent to Suspend products
subject to this Notice due to failure by a registrant to comply
with the requirements of this Data Call-In Notice, pursuant to
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2.
3.
5.
FIFRA section 3(c)(2)(B). Events which may be the basis for
issuance of a Notice of Intent to Suspend include, but are not
limited to, the following:

1. Failure to respond as required by this Notice within 90
days of your receipt of this Notice.

Failure to submit on the required schedule an
acceptable proposed or final protocol when such is
required to be submitted to the Agency for review.

Failure to submit on the required schedule an adequate
progress report on a study as required by this Notice.

Failure to submit on the required schedule acceptable
data as required by this Notice.

Failure to take a required action or submit adequate
information pertaining to any option chosen to address
the data requirements (e.g., any required action or
information pertaining to submission or citation of
existing studies or offers, arrangements, or
arbitration on the sharing of costs or the formation of
Task Forces, failure to comply with the terms of an
agreement or arbitration concerning joint data
development or failure to comply with any terms of a
data waiver).

Failure to submit supportable certifications as to the
conditions of submitted studies, as required by Section
III-C of this Notice.

Withdrawal of an offer to share in the cost of
developing required data.

Failure of the registrant to whom you have tendered an
offer to share in the cost of developing data and
provided proof of the registrant's receipt of such
offer or failure of a registrant on whom you rely for a
generic data exemption either to:

i. Inform EPA of intent to develop and submit the data
required by this Notice on a Data Call-in Response Form
and a Requirements Status and Registrant's Response
Form.

ii. Fulfill the commitment to develop and submit the
data as required by this Notice; or

iii. Otherwise take appropriate steps to meet the
requirements stated in this Notice,
6.
8.
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9.
unless you commit to submit and do submit the required
data in the specified time frame.

Failure to take any required or appropriate steps, not
mentioned above, at any time following the issuance of
this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE

The Agency may determine that a study (even if submitted
^iJ-hin the required time) is unacceptable and constitutes a basis
tor issuance of a Notice of Intent to Suspend. The grounds for
suspension include, but are not limited to, failure to meet any
off the ifol lowing:

1) EPA requirements specified in the Data Call-in Notice
or other documents incorporated by reference (including, as
applicable, EPA Pesticide Assessment Guidelines, Data
Reporting Guidelines, and GeneTox Health Effects Test
Guidelines) regarding the design, conduct, and reporting of
required studies. Such requirements include, but are not
limited to, those relating to test material, test
procedures, selection of species, number of animals, sex and
distribution of animals, dose and effect levels to be tested
or attained, duration of test, and, as applicable, Good
Laboratory Practices.

2) EPA requirements regarding the submission of protocols,
including the incorporation of any changes required by the
Agency following review.

3) EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of
results, and the adequacy of any required supporting (or
raw) data, including, but not limited to, requirements
referenced or included in this Notice or contained in PR
86-5. All studies must be submitted in the form of a final
report; a preliminary report will not be considered to
fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS

EPA has statutory authority to permit continued sale,
distribution and use of existing stocks of a pesticide product
which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.

The Agency has determined that such disposition by
registrants of existing stocks for a suspended registration when

21
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a section 3(c)(2)(B) data request is outstanding generally would
not be consistent with the Act's purposes. Accordingly, the
Agency anticipates granting registrants permission to sell
distribute, or use existing stocks of suspended product(s) only
in exceptional circumstances. If you believe such disposition of
existing stocks of your product(s) which may be suspended for
failure to comply with this Notice should be permitted/ you have
the burden of clearly demonstrating to EPA that granting such
permission would be consistent with the Act. You also must
explain 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, distribution, and
use. Unless you meet this burden, the Agency will not consider
any request pertaining to the continued sale, distribution, or
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Agency of any factual information they have, from whatever
source, including but not limited to interim or preliminary
results of studies, regarding unreasonable adverse effects on man
or the environment. This requirement continues as long as the
products are registered by the Agency.
SECTION VI.
INQUIRIES
RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and
procedures established by this Notice, call the contact person (s)
listed in Attachment 1, the Data Call, -In Chemical Status Sheet.

All responses to this Notice must include completed Data
Call-In Response Forms (Attachment 2) and completed
. and Registrant's Response Forms (Attachment 3), for both
(generic and product specific data] (and any other documents
required by this Notice,, and should be submitted to the contact
person (s) identified in Attachment 1. If the voluntary
cancellation or generic data exemption option is chosen, only the
Generic and Product Specific Data Call-In Response Formg need be
submitted.

The Office of Compliance Monitoring (OCM) of the Office of
Prevention, Pesticides and Toxic Substances (OPPTS) , EPA, will be
wonxtoring the d^ta being generated in response to this Notice.

Sincerely yours,
Daniel M. Barolo, Director
Special Review and
Reregistration Division
Attachments
The Attachments to this Notice are:

1 - nata Call-Tn Chemical status Sheet
2 - Generic Data Call-In and Product Specific Data
call-in Response Forms with Instructions
3 - Generic Data Call-in and Product Specific Data
call-in Requirements Status and Registrant's
Response Forms with Instructions
4 - EPA Grouping of End-Use Products for Meeting Acute
Tnvicoloav Data Requirements for Reregistration
5 - EPA Acceptance Criteria
6 - T.ist of Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms
23
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Attachment 1
Chemical Status Sheet
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GLYPHOSATE: DATA CALL-IN CHEMICAL STATUS SHEET
DATA REQUIRED BY THIS NOTICE

The additional data requirements needed to complete the data
base for glyphosate are contained in Generic PCI and Product
Specific PCI Requirements Status and Registrants Response forms
(Attachment 3).

INQUIRIES AND RESPONSES TO THIS NOTICE

If you have any questions regarding the generic data base
for glyphosate, please contact Eric Feris, the Review Manager for
this chemical through the Virginia Relay (1-800-828-1140) at
(703) 308-8048.

If you have any questions regarding the product specific
data requirements and procedures established by this Notice,
please contact Frank Rubis at (703) 308-8184.

All responses to this Notice should be submitted to:

Eric Feris
Special Review and Reregistration Division (7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460

RE: Glyphosate
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Attachment 2

Generic DCI and Product Specific DCI Response Forms with
Instructions
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Instructions For Completing
The
"Data Call-in Response Forms"
For The Generic And Product Specific Data Call-In
INTRODUCTION

These instructions apply to the Generic and Product Specific
"Data Call-In Response Forms" and are to be used by registrants
to respond to generic and product specific Data Call-ins as part
of EPA's Reregistration Program under the Federal Insecticide
Fungicide and Rodenticide Act. The typ« of data call-in (generic
or product specific) is indicated in item number 3 ("Date and
Typ« of DCI") on each form. BOTH "Data Call-in Response" forms
must be completed.

Although the form is the same for both generic and product
specific data, instructions for completing these forms are
different. Please read these instructions carefully before
filling out the forms.

EPA has developed these forms individually for each
registrant, and has preprinted these forms with a number of
items. DO NOT use these forms for any other active ingredient.

Items 1 through 4 have been preprinted on the form. Items 5
through 7 must be completed by the registrant as appropriate.
Items 8 through 11 must be completed by the registrant before
submitting a response to the Agency.

Public reporting burden for this collection of information
is estimated to average 15 minutes per response, including time
for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and
reviewing the collection of information. Send comments regarding
the burden estimate or any other aspect of this collection of
information, including suggesting for reducing this burden, to
Chief, Information Policy Branch, PM-223, U.S. Environmental
Protection Agency, 401 M St., S.W., Washington, D.C. 20460; and
to the Office of Management and Budget, Paperwork Reduction
Project 2070-0107, Washington/ D.C. 20503.
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In
Item 1. ON BOTH FORMS: This item identifies your company name,
number and address.

Item 2. ON BOTH FORMS: This item identifies the case number,
case name, EPA chemical number and chemical name.

item 3. ON BOTH FORMS: This item identifies the type of Data
Call-in. The date of issuance is date stamped.

Item 4. OH BOTH FORMSi This item identifies the EPA product
registrations relevant to the data call-in. Please
note that you are also responsible for informing the
Agency of your response regarding any product that you
believe may be covered by this Data Call-in but that is
not listed by the Agency in Item 4. You must bring any
such apparent omission to the Agency's attention within
the period required for submission of this .response
fornu ••:••-•

Item 5. ON BOTH FORMS,? Check this item for each product
registration you wish to cancel voluntarily. If a
registration number is listed for a product for which
you previously requested voluntary cancellation,
indicate in Item 5 the date of that request. Since this
Data Call-in requires both generic and product specific
data, you must complete item 5 on both Data Call-In
response forms. You do not need to complete any item
on ,the Requirements Status and Registrant's Response
Forms. ;

Item 6a. ON THE GENERIC DATA FORM: Check this Item if the Data
Call-in is for generic data as indicated in Item 3 and
you are eligible for a Generic Data Exemption for the
chemical listed in Item 2 and used in the subject
product. By electing this exemption, you agree to the
terms and conditions of a Generic Data Exemption as
explained in the Data Call-in Notice.

If you are eligible for or claim a Generic Data
Exemption, enter the EPA registration Number of each
registered source of that active ingredient that you
use in your product.

Typically, if you purchase an EPA-registered product
from one or more other producers (who, with respect to
the incorporated product, are in compliance with this
and any other outstanding Data Call-in Notice), and
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In •.-.....
Item 6b,
Item 7a.
Item 7b,
incorporate that product into all your products, you
may complete this item for all products listed on this
form. If, however, you produce the active ingredient
yourself, or use any unregistered product (regardless
of the fact that some of your sources are registered),
you may not claim a Generic data Exemption and you may
not select this item.

ON THE GENERIC DATA FORM: Check this Item if the Data
Call-in is for generic data as indicated in Item 3 and
if you are agreeing to satisfy the generic data
requirements of this Data Call-In. Attach the
Requirements Status and Registrants Response Form that
indicates how you will satisfy those requirements. ;

NOTE: Item 6a and 6b are not applicable for Product
Specific Data.

ON THE PRODUCT SPECIFIC DATA FORM: For each
manufacturing use product (MUP) for which you wish to
maintain registration, you must agree to satisfy the
data requirements by responding "yes."

For each end use product (EUP) for which you wish to
maintain registration, you must agree to satisfy the
data requirements by responding "yes."

FOR BOTH MUP and EUP products

You should also respond "yes" to this item (7a for
MUP's and 7b for EUP's) if your product is identical to
another product and you qualify for a data exemption.
You must provide the EPA registration numbers of your
source(s); do not complete the Requirements Status and
Registrant's Response form. Examples of such products
include repackaged products and Special Local Needs
(Section 24c) products which are identical to federally
registered products.

If you are requesting a data waiver, answer "yes" here;
in addition, on the "Requirements Status and
Registrant's Response" form under Item 9, you must
respond with option 7 (Waiver Request) for each study
for which you are requesting a waiver.

NOTE: Item 7a and 7b are not applicable for Generic
Data.
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In

Item8* ON BOTH FORMS: This certification statement must be
signed by an authorized representative of your company
and the person signing must include his/her title.
Additional pages used in your response must be
. . initialled and dated in the space provided for the
certification.

Item 9. ON BOTH FORMS: Enter the date of signature.

Item 10. ON BOTH FORMSs Enter the name of the person EPA should
contact with questions regarding your response.

Item 11. ON BOTH FORMS: Enter the phone number of your company
contact.
Note: You may provide additional information that does not
fit oh this form in a signed letter that accompanies
your response. For example, you may wish to report
that your product has already been transferred to
another company or that you have already voluntarily
cancelled this product. For these cases, please supply
all relevant details so that EPA can ensure that its
records are correct.
-------
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Attachment 3

Generic DCI and Product Specific DCI Requirements Status and
Registrants' Response Forms with Instructions
-------
-------
Instructions For Completing
The
"Requirements Status and Registrant's Response Forms"
For The Generic and Product Specific Data Call-in

INTRODUCTION

These instructions apply to the Generic and Product Specific
"Requirements Status and Registrant's Response Forms" and are to
be used by registrants to respond to generic and product specific
Data Call-in's as part of EPA's reregistration program under the
Federal Insecticide Fungicide and Rodenticide Act. The type of
Data Call-In (generic or product specific) is indicated in item
number 3 ("Date and Type of DCI") on each form. Both
"Requirements Status and Registrant's Response" forms must be
completed.

Although the form is the same for both product specific and
generic data/ instructions for completing the forms differ
slightly. Specifically, options for satisfying product specific
data requirements do not include (1) deletion of uses or (2)
request for a low volume/minor use waiver. Please read these
instructions carefully before filling out the forms.

EPA has developed these forms individually for each
registrant, and has preprinted these forms with a number of
items. DO NOT use these forms for any other active ingredient.

Items 1 through 8 have been preprinted on the form. Item 9
must be completed by the registrant as appropriate. Items 10
through 13 must be completed by the registrant before submitting
a response to the Agency.

Public reporting burden for this collection of information
is estimated to average 30 minutes per response, including time
for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and
reviewing the collection of information. Send comments regarding
the burden estimate or any other aspect of .this collection of
information, including suggesting for reducing this burden, to
Chief, Information Policy Branch, PM-223, U.S. Environmental
Protection Agency, 401 M St., S.W., Washington, D.C. 20460; and
to the Office of Management and Budget, Paperwork Reduction
Project 2070-0107, Washington, D.C. 20503.
-------
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANTS RESPONSE FORMS"
Generic and Product Specific Data-Call-in
Item l. ON BOTH FORMS: This item identifies your company name,
number and address.

Item 2. ON THE GENERIC DATA FORM: This item identifies the
case number, case name, EPA chemical number and
chemical name.

ON THE PRODUCT SPECIFIC DATA FORM: This item
identifies the case number, case name, and the EPA
Registration Number of the product for which the Agency
is requesting product specific data.

Item 3. ON THE GENERIC DATA FORM: This item identifies the
type of Data Call-in. The date of issuance is date
stamped. :

ON THE PRODUCT SPECIFIC DATA FORM: This item
identifies the type of Data Call-in. The date of
issuance is also date stamped. -Note the unique
identifier number (ID#) assigned by the Agency. This
ID number must be used in the transmittal document for
any data submissions in response to this Data Call-in
• Notice. •. • ' - - , . •.•"•'<'••'.

Item 4. ON BOTH FORMS8 This item identifies the guideline
reference number of studies required. These
£ guidelines, in addition to the requirements specified
in the Data Call-in Notice, govern the conduct of the
required studies. Note that series 61 and 62 in
product chemistry are now listed under 40 CFR 158.155
through 158.180, Subpart c. -

Item 5. ON BOTH FORMSs This item identifies the study title
associated with the guideline reference number and
whether protocols and 1, 2, or 3-year progress reports
are required to be submitted in connection with the
study. As noted in Section III of the Data Call-In
Notice, 90-day progress reports are required for all
studies.

If an asterisk appears in Item 5, EPA has attached
information relevant to this guideline reference number
to the Requirements Status and Registrant/s Response
Form.
-------
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-In

Item 6. ON BOTH FORMS: This item identifies the code
associated with the use pattern of the pesticide. In
the case of efficacy data (product specific
requirement), the required study only pertains to
products which have the use sites and/or pests
indicated. A brief description of each code followss

A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food crop
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential

Item 7. ON BOTH FORMS: This item identifies the code assigned
to the substance that must be used for testing. A brief
description of each code follows:
EUP
MP
MP/TGAI

PAI
PAI/M
PAI/PAIRA

PAIRA
PAIRA/M

PAIRA/PM

TEP
TEP %

TEP/MET
TEP/PAI/M
End-Use Product
Manufacturing-Use Product
Manufacturing-Use Product and Technical
Grade Active Ingredient
Pure Active Ingredient
Pure Active Ingredient and Metabolites
Pure Active Indredient or Pute Active
Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled
and Metabolites
Pure Active Ingredient Radiolabelled
and Plant Metabolites
Typical End-Use Product
Typical End-Use Product, Percent
Active Ingredient Specified
Typical End-Use Product and Metabolites
Typical End-Use Product or Pure Active
Ingredient and Metabolites
-------
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS ST&TTT<
REGISTRANTS RESPONSE FORMS" " "
Generic and Product Specific Data Call-in
AND
TGAI
TGAI/PAI

TGAI/PAIRA
TGAI/TEP

MET
IMP
DEGR
Technical Grade Active Ingredient
Technical Grade Active Ingredient or
Pure Active Ingredient
Technical Grade Active Ingredient or
Pure Active Ingredient
Radiolabelled
Technical Grade Active Ingredient or
Typical End-Use Product
Metabolites
Impurities
Degradates
See: guideline comment
Item 8.
Item 9.
This item completed by the Agency identifies the time
frame allowed for submission of the study or protocol
identified in item 5.

ON THE GENERIC DATA FORM: The time frame runs from the
date of your receipt of the Data Call-in notice.

ON THE PRODUCT SPECIFIC DATA FORMS The due date for
submission of product specific studies begins from the
date stamped on the letter transmitting the
Reregistration Eligibility Decision document, and not
from the date of receipt. However, your response to
the Data Call-in itself is due 90 days from the date of
receipt.

ON BOTH FORMS: Enter the appropriate Response Code or
Codes to show how you intend to comply with each data
requirement. Brief descriptions of each code follow.
The Data Call-in Notice contains a fuller description
of each of these options.

Option 1. ON BOTH FORMS: (Developing Data) I will conduct a
new study and submit it within the time frames
specified in item 8 above. By indicating that I
have chosen this option, I certify that I will
comply with all the requirements pertaining to the
conditions for submittal of this study as outlined
in the Data Call-in Notice and that I will provide
the protocols and progress reports required in
item 5 above.

Option 2. ON BOTH FORMS: (Agreement to Cost Shared I have
entered into an agreement with one or more
registrants to develop data jointly. By indicating
-------
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-In

that I have chosen this option, I certify that I
will comply with all the requirements pertaining
to sharing in the cost of developing data as
outlined in the Data Call-in Notice.

However, for Product Specific Data, I
understand that this option is available for acute
toxicity or certain efficacy data ONLY if the
Agency indicates in an attachment to this notice
that my product is similar enough to another
product to qualify for this option. I certify that
another party in the agreement is committing to
submit or provide the required data; if the
required study is not submitted on time, my
product may be subject to suspension.

Option 3. ON BOTH FORMS; (Offer to Cost Share) I have made
an offer to enter into an agreement with one or
more registrants to develop data jointly. I am
also submitting a completed "Certification of
offer to Cost Share in the Development of Data"
form. I am submitting evidence that I have made
an offer to another registrant (who has an
obligation to submit data) to share in the cost of
that data. I am including a copy of my offer and
proof of the other registrant's receipt of that
offer. I am identifying the party which is
committing to submit or provide the required data;
if the,required study is not submitted on time, my
product may be subject to suspension. I understand
that other terms under Option 3 in the Data
Call-in Notice apply as well.

However, for Product Specific Data, I
understand that this option is available only for
acute toxicity or certain efficacy data and only
if the Agency indicates in an attachment to this
Data Call-In Notice that my product is similar
enough to another product to qualify for this
option.

Option 4. ON BOTH FORMS: ^submitting Existing Data) I will
submit an existing study by the specified due date
that has never before been submitted to EPA. By
indicating that I have chosen this option, I
certify that this study meets all the requirements
pertaining to the conditions for submittal of
-------
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANTS RESPONSE FORMS"
Generic and Product Specific Data Call-In

existing data outlined in the Data Call-in Notice
and I have attached the needed supporting
information along with this response.

Option 5. ON BOTH FORMS: (Upgrading a Studvl I will submit
by the specified due date, or will cite data to

upgrade a study that EPA has classified as
partially acceptable and potentially upgradeable.
By indicating that I have chosen this option, I
certify that I have met all the requirements
pertaining to the conditions for submitting or
citing existing data to upgrade a study described
in the Data Call-in Notice. I am indicating on
attached correspondence the Master Record
Identification Number (MRID) that EPA has assigned
to the data that I am citing as well as the MRID
of the study I am attempting to upgrade.

Option 6. ON BOTH FORMSs (Citing a Studvl I am citing an
existing study that has been previously classified
by EPA as acceptable, core, core minimum, or a
study thcit has not yet been reviewed by the
Agency. If reviewed, I am providing the Agency's
classification of the study.

However, for Product Specific Data, I am
citing another registrant's study. I understand
that this option is available ONLY for acute
toxicity or certain efficacy data and ONLY if the
cited study was conducted on my product, an
identical product or a product which the Agency
has "grouped" with' one or more other products for
purposes of depending on the same data. I may also
choose this option if I am citing my own data. In
either case, I will provide the MRID or Accession
number (s). If I cite another registrant's data,
I will submit a completed "Certification With
Respect To Data Compensation Requirements" form.

FOR THE GENERIC DATA FORM ONLY; The following three options
(Numbers 7, 8, and 9) are responses that apply only to the
"Requirements Status and Registrant's Response Form" for
generic data.

Option 7. (Deleting Uses) I am attaching an application for
amendment to my registration deleting the uses for
which the data are required.
-------
FOR COMPLETING THE "REQUIREMENTS STATUS AND
RESPONSE FORMS"
Generic and Product Specific Data Call-in

Option 8. n^ow volume /Minor Use Waiver Request) I have read
the statements concerning low volume-minor use
data waivers in the Data Call-in Notice and I
request a low-volume minor use waiver of the data
requirement. I am attaching a detailed
justification to support this waiver request
including, among other things, all information
required to support the request. I understand
that, unless modified by the Agency in writing,
the data requirement as stated in the Notice
governs .

Option 9. (Peguest f»r- waiver of Data) I have read the
P statements concerning data waivers other than low-
volume minor-use data waivers in the Data Call-in
Notice and I request a waiver of the data
requirement. I am attaching a rationale explaining
why I believe the data requirements do not apply.
I am also submitting a copy of my current labels.
(You must also submit a copy of your Confidential
Statement of Formula if not already on file with
EPA) . I understand that, unless modified by the
Agency in writing, the data requirement as stated
in the Notice governs.

PQR PRODUCT SPECIFIC DRTAs The following °Pti°-Boin?llbe!LJ)
is a response that applies to the "Requirements Status and
Registrant's Response Form" for product specific data.
Option 7. (MHvar Request) I request a waiver for this
study because it is inappropriate for my product*
I am attaching a complete justification for this
request, including technical reasons, data and
references to relevant EPA regulations, guidelines
or policies. [Note: any supplemental data must be
submitted in the format required by P.R. Notice
86-51. I understand that this is my only
opportunity to state the reasons or provide
information in support of my request. If the
Agency approves my waiver request, I will not be
required to supply the data pursuant to Section
3(c) (2) (B) of FIFRA. If the Agency denies my
waiver request, I must choose a method of
meetingthe data requirements of this Notice by the
due date stated by this Notice. In this case, I
must, within 30 days-of my receipt of the Agency s
written decision, submit a revised "Requirements
Status" form specifying the option chosen. I also
-------
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"~T
Generic and Product Specific Data
Item 10,
Item 11,

Item 12.

Item 13.
understand that the deadline for submission of
data as specified by the original Data Call-in
notice will not change.

ON BOTH FORMS: This item must be signed by an
authorized representative of your
company. The person signing must include
his/her title, and must initial and date
all other pages of this form.

ON BOTH FORMS: Enter the date of signature.
ON BOTH FORMS
Enter the name of the person EPA should
contact with questions regarding your
response.
ON BOTH FORMS: Enter the phone number of your company
contact.
NOTE;
You may provide additional information that does riot
fit on this form in a signed letter that accompanies
this your response. For example, you may wish to report
that your product has already been transferred to
another company or that you have already voluntarily
cancelled this product. For these cases, please supply
all relevant details so that the Agency can ensure that
its records are correct.
-------
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-------
Attachment 4

EPA Grouping of End Use Products for meeting Acute Toxicology Data
Requirements
-------
-------
EPA'8 BATCHING OF GLYPHOSATB PRODUCTS FOR MEETING ACUTE TOXICITY
DATA REQUIREMENTS FOR REREGISTRATION

In an effort to reduce the time, resources and number of
animals needed to fulfill the acute toxicity data requirements
for reregistration of products containing the active ingredient
glyphosate, the Agency has batched products which can be
considered similar for purposes of acute toxicity. Factors
considered in the sorting process include each product's active
and inert ingredients (identity, percent composition and
biological activity), type of formulation (e.g., emulsifiable
concentrate, aerosol, wettable powder, granular, etc.), and
labeling (e.g., signal word, use classification, precautionary
labeling, etc.), Note that the Agency is not describing batched
products as "substantially similar" since some products within a
batch may not be considered chemically similar or have identical
use patterns.

Batching has been accomplished using the readily available
information described above, and frequently acute toxicity data
on individual products has been found to be incomplete. Notwith-
standing the batching process, the Agency reserves the right to
require; at any time, acute toxicity data for an individual
product should the need arise.

Registrants of products within a batch may choose to
cooperatively generate, submit or cite a single battery of six
acute toxicological studies to represent all the products within
that batch. It is the registrants' option to participate in the
process with all other registrants, only some of the other
registrants, or only their own products within a batch, or to
generate all the required acute toxicological studies for each of
their own products. If a registrant chooses to generate the data
for a batch, he/she must use one of the products within the batch
as the test material. If a registrant chooses to rely upon
previously submitted acute toxicity data, he/she may do so
provided that the data base is complete and valid by today^s
standards (see acceptance criteria attached), the formulation
tested is considered by EPA to be similar for acute toxicity, and
the formulation has not been significantly altered since
submission and acceptance of the acute toxicity data. Regardless
of whether new data is generated or existing data is referenced,
registrants must clearly identify the test material by EPA
Registration Number.

In deciding how to meet the product specific data
requirements, registrants must follow the Directions given in the
Data call-in Notice and its attachments appended to the RED. The
DCI Notice contains two response forms which are to be completed
and submitted to the Agency within 90 days of receipt. The first
lSrmr»Data Call-In Response," asks whether the registrant will
meet the data requirements for each product. The second form,
"Requirements Status and Registrant's Response," lists the
-------
product specific data required for each product, including the
standard six acute toxicity tests. A registrant who wishes to
participate in a batch must decide whether he/she will provide
the data or depend on someone else to do so. If a registrant
supplies the data to support a batch of products, he/she must
select one of the following options: Developing Data (Option 1),
Submitting an Existing Study (Option 4), Upgrading an Existing
Study (Option 5} or Citing an Existing Study (Option 6). If a
registrant depends on another's data, he/she must choose among:
Cost Sharing (Option 2), Offers to Cost Share (Option 3) or
Citing an Existing study (Option 6). If a registrant does not
want to participate in a batch, the choices are Options 1, 4, 5
or 6, However, a registrant should know that choosing not to
participate in a batch does not preclude other registrants in the
batch from citing his/her studies and offering to cost share
(Option 3) those studies.

Fifty-six products were found which contain glyphosate as
the active ingredient. The products have been placed into five
batches and a "no batch" category in accordance with the active
and inert ingredients, type of formulation and current labeling.
Table l identifies the products in each batch. Table 2 lists the
twenty-seven products which have been placed in the "no batch"
category.

The Agency requires that products in batch four include
separate primary eye irritation studies for each product within
these batches. The remaining acute toxicity requirements for the
products in batch four may be satisfied by one of the procedures
described above.
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latdi
1

2
3
4
5
EPA Keg. Ho. .
70-269
239-2467
524-330
7401-304
7401-307
7401-357
7401-400
7401-401
7401-402
7401-403
10370-282
10583-14
46515-5
56644-64
19713-320
46515-7
70-284
7401-306
7401-404
34911-25
46515-3
56644-48
524-339
524-454
524-318
524-343
524-350

X GlyphoMta
0.96
0.5
0.96
0.5
0.5
1.0
1.0
0.5
0.5
0.5
0.96
0.96
0.96
0.96
0.96
0.96
5.0
5.0
5.0
5.0
5.0
5.0
41.0
41.0
53.5
53.8
53.8
53.8
Fonulatfoh Typ«
Liq
Llq
Liq
Lfq
Liq
Liq
Lfq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Aerosol
Aerosol
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
-------
Table II lists products that were either considered not to be si«ilar or the Agency lacked
sufficient information for decision Making and were not plac«d in any batch. Registrants of these products
are responsible for Meeting the acute toxicity data requirements separately for each product.

Table 2 (No batch)
EPA Reg. Ho.
239-2469
239-2509
239-2516
239-2596
524-308
524-326
524-332
524-333
524-341
524-370
S24-376
524-382
524-390
524-420
524-421
524-435
524-439
524-440
524-445
524-449
524-450
524-451
524-452
524-432
7401-405
935-48
10370-283
10583-15
X 6ly$taeat» and other actives
Glyphosate 5.0
Glyphosato 0.5, Acifluorfen 0.12
Giyphosate 0.25LOxyfluorfen 0.25
Slyphosats 0.73
Glyphosata 41.0
Glyphosate 41. 5
Glyphosate 75.0
Glyphosate 62.0
Glyphosate 14.8, Alachlor 27.6
Glyphosate 18.0
Glyphoaate 13.3, 2.4-0 11.1
Glyphasat* 28.6
Glyphosate 16.5, Oleanfca 7.'0
Glyphosate 96.3
Glyphosate 76.0
Glyphosate 83.5
Glyphosate 7.7, Oxadiazon 14.9
Glyphosate 25.1
Glyphosate 41.0
Glyphosate 12.4, Oryzalin 11.8
Glyphosate 15.8
Glyphosate 0.96
Glyphosate 60.0
Glyphosate 18.3
Glyphosate 10.0
Glyphosate 12.9. 2.4-D 20.6
Glyphosate 10.0
Glyphosate 8.2
Fonulat tan Type
Liq
Liq I
Liq J
a_™____j
— ™—~
Liq I
. i^ 1
Liq 1
Solid
Liq
Liq
Liq
Liq
Liq
Liq
Solid
Solid
Capsular
Liq
Liq
Liq
Liq
Liq
Liq
Solid
Liq
Liq
Lia
Liq
Liq
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Attachment 5
EPA Acceptance Criteria
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SUBDIVISION D
Guideline

Series 61
Series 62
Series 63
Study Title

Product Identity and Composition
Analysis and Certification of Product Ingredients
Physical and Chemical Characteristics
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61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?

1. Name of technical material tested (include product name and trade name, if appropriate).

2. Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and each
intewionally-added inert ingredient.

3. Naifw and upper certified limit for each impurity or each group of impurities present at >. 0.1% by
weight and for certain lexicologically significant impurities (e.g., dioxins, nitrosamines) present at
4. Purpose.of each aciive ingredient and each inientionally-added inert.

5. Chemical name from Chemical Abstracls index of Nomenclature and Chemical Absiracts Service (CAS)
Registry Number fqr each active ingredient and, if available, for each intentionally-added inert.

6. Molecular, structural, and empirical formulas, molecular weight or weight range, and any company
assigned experimental or internal code numbers for each aciive ingredient.
Description of each beginning material in the manufacturing process.
EPA Registration Number if registered; for other beginning materials.
the Mowing:
Name and address of manufacturer or supplier.
Brand name, trade name or commercial designation.
~ Technical specifications or data sheets by which manufacturer or supplier describes composition,
properties or toxicity. =

Description of manufacturing process.
Statement of whether batch or continuous process.
Relative amounts of beginning materials and order in which they are added.
Description of equipment.
Description of physical conditions (temperature, pressure, humidity) controlled in each step and
the parameters that are maintained.
Statement of whether process involves intended chemical reactions.
Flow chart with chemical equations for each intended chemical reaction.
Duration of each step of process.
Description of purification procedures.
Description of measures taken to assure quality of final product.

Discussion of formation of impurities based on established chemical theory addressing (1) each impurity
which may be present at ^. 0.1% or was found at >_'0.l% by product analyses and (2) certain
lexicologically significant impurities (see #3).
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62 Analysis and Certification of Product Ingredients

ACCEPTANCE CRITERIA

The following criteria apply to the technical grade of the active ingredient being reregistered. Use a table to present
the information in items 6, 7, and 8. '

Does your study meet the following acceptance criteria?

1 • Five or more representative samples (batches in case of batch process) analyzed for each active ingredient
and all impurities present at J>. 6.1 %.
2. Degree of accountability or closure J>. eg 98%.
3. __ Analyses conducted for certain trace toxic impurities at lower than 0.1% (examples, nitrosamines in the
case of products containing dinitroanilines or containing secondary or tertiary amines/alkanolamines plus
nitrites; polyhalogenated dibenzodioxins and dibenzofurans). {Note that in the case of nitrosamines both
fresh and stored samples must be analyzed.].
4. Complete and detailed description of each step in analytical method used to analyze above samples.
5. Statement of precision and accuracy of analytical method used to analyze above samples.
6. Identities and quantities (including mean and standard deviation) provided for each analyzed ingredient.
7. Upper and lower certified limits proposed for each active ingredient and intentionally added inert along
with explanation of how the limits were determined.
8._^ Upper certified limit proposed for each impurity present at .>. 0.1% and for certain lexicologically
significant impurities at < 0.1% along with explanation of how limit determined.
9. Analytical methods to verify certified limits of each active ingredient and impurities (latter not required
if exempt from requirement of tolerance or if generally recognized as safe by FDA) are fully described.
10._: Analytical methods (as discussed in #9) to verify certified limits validated as to their precision and
accuracy.
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63 Physical and Chemical Characteristics

ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered.

Does your study meet the following acceptance criteria?

63-2 Color
Verbal description of coloration (or lack of it)
Any intentional coloration also reported in terms of Munsell color system

63-3 Physical State
Verbal description of physical state provided using terms such as "solid, granular, volatile liquid"
Based on visual inspection at about 20-25° C
63 4 Odor
Verbal description of odor (or lack of it) using terms such as "garlic-like, characteristic of aromatic
compounds"
Observed at room temperature
63-5 Melting Point
Reported hi °C
_ Any observed decomposition reported

63-\) Bulling Point
Reported in °C
__ _ Pressure under which B.P. measured reported
Any observed decomposition reported

63-7 Density, Bulk Density, Specific Gravity
Measured at about 20-25° C
Density of technical grade active ingredient reported in g/ml or the specific gravity of liquids reported
with reference to water at 20° C. [Note: Bulk density of registered products may be reported hi lbs/ft3
or Ibs/gallon.]

63-8 Solubility
Determined in distilled water and representative polar and non-polar solvents, including those used hi
formulations and analytical methods for the pesticide
Measured at about 20-25° C
Reported in g/100 ml (other units like ppm acceptable if sparingly soluble)

63-9 Vapor Pressure
Measured at 25° C (or calculated by extrapolation from measurements made at higher temperature if
pressure too low to measure at 25° C)
Experimental procedure described
Reported hi mm Hg (ton) or other conventional units

63-10 Dissociation Constant
Experimental method described
Temperature of measurement specified (preferably about
20-25 °C)
-------
63-11 Octanol/water Partition Coefficient
• Measured at about 20-25° C
Experimentally determined and description of procedure provided (preferred method-45 Fed Register
77350)
Data supporting reported value provided
63-12 pH
Measured at about 20-25° C
Measured following dilution or dispersion in distilled water
-J3 Stabuuy
._. Seuuifiviiy to metal ions and metal determined
.. Stability at normal and elevated temperatures'
Sensjtivity to sunlight determined
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SUBDIVISION F
Guideline

81-1
81-2

81-3
81-4
81-5
81-6
Study Title

Acute Oral Toxicity in the Rat
Acute Dermal Toxicity in the Rat, Rabbit or Guinea
Pig
Acute Inhalation Toxicity in the Rat
Primary Eye Irritation in the Rabbit
Primary Dermal Irritation Study
Dermal Sensitization in the Guinea Pig
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81-1 Acute Oral Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?

I. Identify material tested (technical, end-use product, etc).
2. At least 5 young adult rats/sex/group.
3. Dosing', single oral may be administered over 24 hrs.
4."_, _ Vehicle control if other than water.
•$._ _ Doses tested, sufficient to determine a toxicity category or a limit dose (5000 mg/kg).
6. Individual observations at least once a day.
7. Observation period to last at least 14 days, or until ail test animals appear normal whichever is longer.
8. Individual daily observations.
9. Individual body weights.
10. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study:
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81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig

ACCEPTANCE CRITERIA

Does your study meet the following acceptance criteria?

1- Identify material tested (technical, end-use product, etc).
2. At least 5 animals/sex/group.
3..! Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
4. Dosing, single dermal.
.1- Dosing duration at least 24 hours.
6--t_ .. Vehicle control, only if toxicity of vehicle is unknown.
7-_ : .„ Doses tested, sufficient to determine a toxicity category or a limit dose (2000 rag/kg).
8. Application site clipped or shaved at least 24 hours before dosing.
9._ Application site at least 10% of body surface area.
10- Application site covered with a porous nonirritating cover to retain test material and to prevent
• ingestion.
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be .required for every study.
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81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?

1. Identify material tested (technical, end-use product, etc).
2. Product is a gas, a solid which may produce a significant vapor hazard based on toxiciry and expected use
or contains particles of inhalable size for man (aerodynamic diameter 15 pm or less).
3. At least 5 young adult rats/sex/group.
4. Dosing, at least 4 hours by inhalation.
5. Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
^'Zl" Chamber temperature, 22° C (±2°), relative humidity 40-60%.
7.. _71 Monitor rate of air flow.
8.^""' Monitor actual concentrations of test material in breathing zone.
9.^ Monitor aerodynamic panicle size for aerosols.
10. Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of
respirable substance).
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
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81-4 Primary Eye Irritation in the Rabbit

ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?

1. Identify material tested (technical, end-use product, etc).
2.. Study not required if,material is corrosive, causes severe ..'-,.'
dermal irritation or has a pH of <2 or .Ml.5.
3. 6 adult rabbits.
4, Dosing, instillation into the conjunctiva! sac of one eye
per animal.. , . , .
5.___ Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if a solid, paste or paniculate substance.
6. Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 24 hours. , , '
8. Eyes examined and graded for irritation before dosing and
. at ls, 24, 48,.an.d 72 hr, .then daily until eyes are normal
or 21 days (whichever is shorter).
9.* Individual daily observations.
Criteria marked with an * are supplemental and may not be required for .every study.
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81-5 Primary Dermal Irritation Study

ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria? .

I. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a pH of .! 1.5.
3. 6 adult animals.
4. Dosing, single dermal.
5. Dosing duration 4 hours.
6.— __ application site shaved or clipped at least 24 hours prior to dosing.
?•„_. Application site approximately 6 cm1.
8." Application site covered with a gauze patch held in place with nonirritating tape.
9. Material removed, washed with water, without trauma to applkation site.
10. Application site examined and graded for irritation at 1, 24, 48 and 72 hr, then daily until normal or 14
days (whichever is shorter).
11.* Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
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81-6 Dermal Sensitization in the Guinea Pig

ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria? .,

I- Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a
" pHof_<2or.>11.5.
3. One of the following methods is utilized:
Freund's complete adjuvant test
Guinea pig maximization test .
Split adjuvant technique
Buehlertest, , .- ... , ..'..'
___ Open epicutaneous test ,
>. Mauer optimization test .
Footpad technique in guinea pig. .
4.J Complete description of test.
5.f Reference for test.
6. Test followed essentially as described in reference document.
7. Positive control included (may provide historical data conducted within the last 6 months).
Criteria marked with an * are supplemental and may not be required for every study.
-------
Attachment 6
List of all Registrants sent this DCI
-------
-------
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-------
-------
Attachment 7
Cost Share/Data Compensation Forms
-------
-------
^•••••••1^

&EPA
United States Environmental Protection Agency
Washington, DC 20450
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
Pan* A»af*v»a*

OUt Na. 2070-0107
2070-0037
Aaaraval bf>lfM S-s:
PubOc rtoortlno burden for this collection o( Information is estimated to average 15 minutes per response,
£5 for rivX* instructions, searching existing data sources, gathering "d mato
ompleUng and reviewing the coBectton of Information. Send comments ***»**»
asoect of it^^llsS^^-'ia^^on^ redudn this burden.
^
w PI/MBS, U.S. Environmental Protection Agency, 401 M St.. S.W, Washington. DC 2W60; and to the Off*
^Management and Budget, Paperwortc Reduction Project (2070-0106), Washington, DC 20503.

Please fill In blanks below.
Company Nama
**»«
Company Numbair
ICertMythat:

1 For each study cited in support of registration or reregistratten under the
* RodanSdaM (FIFRA) that is an exclusive use study. I am the original data submitter, or I have
written permission of the original data submitter to ctte that study.

2 Thatfor each study dted h support of registration or rertgistratfen under FIFRA that is NOT an Delusive use
2' IwSSfS** o*.S£5tter. or I have obtained me <^ P"*^"™g? Kg"**' *
hav«Ino«fia« m writing the companyOes) that submitted data I have dted;•«« hajja oftere*»•<•>***„-„
eonttensfittoA for those data in accordance with sections 3(C)(1)(D) and 3(c)(2)(D) of FIFRA, and (b) wmmence
negotiation to determine which data are subject to the compensation requirement of FIFRA and the amount of
compensation due, If any. The companies I have notified are: (check one)

I ] AH companies on the data submitters' fist for the active ingredient fisted on this term (Cite-All
Methoclor Cite-All Option under the Selective Method). (Also sign the General Offer to Pay
betow.)

fl The companies who have submitted the studies listed on the back of this tonn or attached
sheets, oriIndicated on the attached -Requirements Status and Registrants' Response Form.

3. Thatlluwiwvtouslycoi*>iWi^
registration or reregistration under FIFRA.
Hmi «nd Tllto (PiMM TyM «r Mnt)
Oat*
I hereby offer and agree to pay compensation to other ptrsons, with regard to the
* FlFRA MCtton$ 3(c)(l)(P)«nd3(c){2)(D).
atgnatura m.
Data
MMM and Till* (»laua Typa af Print)
EPA form S57041 (4-tO)
-------
-------
United States Environmental Protection Ageney
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
OUI M*.
1070-0107
1070-0057
M SOI-
Public reoortina burden for this collection of Information Is estimated to average IS minutes per response, Including
time for Viewing instructions, searching existing data sources, gathering and maintaining the data needed, and
comoletina and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of Information, Including suggestions for reducing this burden, ^^Sonrjation PoHcy
Branch PM-223, U.S. Environmental Protection Agency, 401 M St., S.W, Washington. DC 2M60; and to the Otficx
oSgTmenTand Budget. Paperwork Reduction Project (2070-0106), Washington. DC 20*03. .

Please fill In blanks below.
Cotnptny K*m«
Karoo
Company Number
EPA
Number
t Certify that:

My company is wilting to devalp and submit the data required by EPA under the authority of the Federal
FunfltekJe and RodentfckJe Act (FIFRA). if necessary. However, my company would preer to
» agrtVmem with one or more Registrants to develop Jointly or .hare in the cost of developing
firm has offered in writing to tnter into *ueh an agreement. That offer was Irrevocable and inducted a
f^ M iSuSb! ^IStraStIon decision under section 3(c){2)(B)(no^FIF^H final agreement on al
rmVcoutd not be reached otherwise. This offer was made to the following flrm(s) on the foltowing
date(s): _
Kern* •! Flm(»)
OHw
Certftiealtom
, and that the statements that I havemadeon
. I acknowledge that any knowingly false or
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