United Sates Office of Prevention, Pesticides EPA 738-R-93-OM
Environmental Protection And Toxic Substances September 1993
Agency ^ (750BW) ^^
&EPA Registration
Eligibility Decision (RED)
*
Glyphosate
Recycled/Recyclable
Primed with Scy/Canota Ink cm paper that
contains 81 toast 50% recycled fiber
-------
I
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
FEE | 6 1994
OFFICE OF
PREVENTION, PESTICIDES AND
TOXIC SUBSTANCES
CERTIFIED KAIL
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 IREP)
Document 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 facts
and the Pesticide Rerecri st rat ion 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' sResponse Formf 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 iCa 11-In 'Response
Form and Requirements Status and Registrant's Response Form. These
forms are in the appendices to the RED.
Recycl»d/R»cyclabte
PiMttf wWi Soy/CMWU fc* on p>p*f B»l
eoma>m «i«Mt S0% meydM fiber
-------
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 RID.
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 pavs of Your Receipt of this Letter
1. For each product which is subject to this RED, you Bust
complete, sign and submit the data call-in (DCI) 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 toe DCI forms are to be sent to the
Special Review and Reregistration Division (use the mailing
distribution code RED-SRRD-0178 for your generic response}*
2. Mo 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
1. 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
-------
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 with 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 with the Agency, you must contact Eric Feris within two weeks
of your receipt of the RED. The Agency intends to have one
combined* meeting with interested registrants. Zf 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
-------
-------
i
United States Prevention, Pesticides EPA-73B-F-93-On
Environmental Protection And Toxic Substances September 1993
Agency f7508W)
R.E.D. FACTS
Glyphosate
Pesticide All pesticides sold or distributed in the United States must be
Reregistration 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 reregistration, EPA announces this
and explains why in a Reregistration Eligibility Decision (BED) document.
This fact sheet summarizes the information hi 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 were
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.
-------
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 naonoammonium salt of glyphosate is an active ingredient in an
additional seven herbicide/growth regulator products. This form of
giyphosate was initially registered after November 1984, so it is not subject
to reregistration or included in this RED. However, in reassessing the
existing glyphosate tolerances (maximum residue limits in or on food and
feed), EPA included those for the monoammonium salt.
Regulatory
History
EB^ issued a Registration Standard for glyphosate in June 1986
(NTIS PB87-103214). The Registration Standard required additional
phytotoxicity, environmental fate, toxicology, product chemisisy and
residue chemistry studies. All of the data required have been submitted
and reviewed, or were waived.
Human Health
Assessment
Toxfcity
Glyphosate is of relatively low oral and dermal acute toxicity. It has
been placed in Toxicity Category HI 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 gains in
both sexes at the highest dose levels. A dermal study with rabbits showed
slight reddening and swelling of the skin, decreased food consumption in
males and decreased enzyme production, at the highest dose levels.
Several chronic toxicity/carcinogenicity studies using rats, mice and
beagle dogs resulted in no effects based on the parameters examined, or
resulted in 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 carcuiogenicity 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.
-------
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 onJy 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 in urine and feces. Enforcement methods are
available to detect residues of glyphosate and AMPA in or on plant
commodities, in water and in animal 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 mam' 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 created 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
carcinogeniciry), 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. %vho report
numerous incidents of eye and skin irritation from splashes during mixing
-------
i
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 in the
few, narrow exceptions allowed in 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 glyphosae's low acute toxiciry. 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
in 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 tour REI set by the WPS.
Environmental Environmental Fate
Assessment 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
-------
I
glyphosate by drift. EPA therefore 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
Required
EPA is requiring three generic studies (Her n Vegetative Vigor,
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 c
Non-Aquatic Uses - End-use products that are not registered for
aquatic uses must bear the following label statement:
Do not apply directly to wafer, to areas where surface miter 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.
-------
• 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 in the RED, all statements required by these
two PR Notices must appear on product labeling exactly as instructed in
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:
e. 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 or
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 their 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."
° 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:
0 No new entry restrictions must be added. However, any entry
restrictions on current product labeling must be retained.
-------
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 a Notice of Availability published in the Federal Register.
To obtain a copy of the REP document or to submit written comments,
please contact the Pesticide Docket, Public Response and Program
Resources Branch, Field Operations Division (7506C)r 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 XNT1S), 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.
-------
i
-------
i
REREGISTRATION ELIGIBILITY DECISION DOCUMENT
GLYPHOSATE
LIST A
CASE 0178
US Environmental Protection Agency
Office of Pesticide Programs
Special Review and Reregsitration Division
-------
i
-------
GLYPHOSA TE RED
September 1993
GLYPHOSATE REREGISTRATION ELIGIBILITY TEAM
Office of Pesticide Programs:
Special Review and Reregistration Division
Eric Feris 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
Bernice 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
-------
GLYPHOSA TE RED
September 1993
TABLE OF CONTENTS
GLOSSARY OF TERMS AND ABBREVIATIONS vi
EXECUTIVE SUMMARY viii
I. INTRODUCTION 1
II. 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
III. 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
-------
GLYPHOSA TE RED
September 1993
f. Reproductive Toxicity 16
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
C. 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
-------
GLYPHOSA TE RED
September 1993
A. Determination of Eligibility 57
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 - Table of the Generic Data Requirements and Studies Used to Make the
Reregistration Decision
iv
-------
GLYPHOSA TE RED
September 1993
Appendix C -
Appendix D -
Appendix E -
Appendix F -
Citations Considered to be Part of the Data Base Supporting the
Reregistration of Glyphosate
List of Available Related Documents
Pesticide Reregistration Handbook
Generic and Product-Specific Data Call-In
! Attachment 1 - Chemical Status Sheet
! Attachment 2 - 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.
! Attachment 5 - EPA Acceptance Criteria
! Attachment 6 - List of all Registrant(s) sent this Data Call-In
! Attachment 7 - Cost Share/Data Compensation Forms
-------
GLYPHOSA TE RED
September 1993
a.i.
CAS
CFR
CSF
EEC
EP
EPA
FIFRA
FFDCA
FR
HOT
LC50
LD
50
LD|0
LEL
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 orppm.
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
VI
-------
GLYPHOSA TE RED
September 1993
MATC 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).
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
PAD I Provisional Acceptable Daily Intake
ppm Parts Per Million
RE I 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
-------
GLYPHOSA TE 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 broad leaf 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
monoammonium salt of glyphosate.
In June 1986, the Agency issued the document "Registration Standard for Pesticide
Products Containing Glyphosate as the Active Ingredient" (NTIS #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 necessitates the labelling of some
VIM
-------
GLYPHOSA TE RED
September 1993
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 II 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 the revised labels, the Agency will determine
whether to re-register a product based on whether or not that product meets the requirements
in Section 3(c)(5) of FIFRA. End use products containing glyphosate in combination with
other active ingredients will not be re-registered until the Reregistration Eligibility Decisions
for all active ingredients contained in that product are issued and all the active ingredients
contained in the product are also eligible for reregistration. However, product specific data for
these products are being called in at this time.
IX
-------
GLYPHOSA TE 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 "the 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 determine 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
ofglyphosate. Except where explicitly noted otherwise, the term "glyphosate," when used
in this document, refers to either the technical acid or the isoproplyam ine 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
1 EPA's reviews of data on the set of registered uses considered for EPA's analysis may be obtained from the OPP P
Field Operations Division (H7506C), Office of Pesticide Programs, EPA, Washington, DC 20460.
-------
GLYPHOSA TE RED
September 1993
CASE OVERVIEW
A. Chemical Overview
The following active ingredient(s) are covered by this Reregistration
Eligibility Document:
Common Name:
Chemical Name:
CAS Registry Number:
OPP Chemical Codes:
Empirical Formula:
Trade Names:
glyphosate
N-phosphonomethyl glycine
38641-94-0
103601 (isopropylamine salt)
103603 (sodium salt)
C3H8N05P
Roundup, Rodeo, Shackle
Basic Manufacturer: 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.
-------
GLYPHOSA TE 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-in use.
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
(proso), 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 Galea), carrot (including tops), cashew, cauliflower, celery,
chard (swiss), cherimoya, cherry, chestnut, chicory, cocoa, coffee, collards,
cranberry, cress (water), cucumber, currant, date, dewberry, eggfruittree (canistel),
eggplant, elderberry, endive (escarole), fig, filbert (hazelnut), garlic, gooseberry,
gourds, groundcherry (strawberry tornato/tomatiHo), guava, hickory nut, horseradish,
huckleberry, jaboticaba, jackfruit, kale, kitembilla (ceylon gooseberry), kiwi fruit,
kohlrabi, leek, lettuce, litchi nut, loganberry, longan, loquat, macadamia nut
-------
GLYPHOSA TE RED
September 1993
(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 than tangelo, 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:
agricultural fallow/idleland, agricultural rights-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.
-------
GLYPHOSA TE 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 % glyphosate, isopropylamine salt
0.50 % glyphosate, isopropylamine salt
Manufacturing Use
94.00 % glyphosate, isopropylamine salt
Pelleted/Tableted
83.50 % glyphosate, 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 salt
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
-------
GLYPHOSA TE 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 other 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 % glyphosate, 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
-------
GLYPHOSA TE 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.
Glyphosate Usage
Site
non-ag areas
almonds
Multiple Acres
Treated (xlOOO)
unknown
350-390
Pounds AI
(xlOOO)
3000-7000
500-550
-------
GLYPHOSA TE RED
September 1993
apples
barley
cherries
com, field
cotton
hay /pasture
dry edible beans/peas
grapefruit
grapes
lemons
other ag sites
oranges
peaches
peanuts
pears
pecans
plums/prunes
rice
sorghum
soybeans
spring wheat
sugarcane
potatoes
sunflowers
sweet corn
tomatoes
green beans/peas
walnuts
\\T~\n\ f*r \\T\\f*Q\
75-275
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
T.S.CI i i <;n
65-200
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
5-40
25-30
100-150
2,200-2,400
50-60
5-35
25-30
25-40
5-15
15-30
5-20
100-125
9<;n AS.CI
8
-------
GLYPHOSA TE RED
September 1993
TOTAL 12,985-20,280 11,398-18,745
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.
D. Data Requirements
Data required in the June 1986 Registration Standard forglyphosate 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.
SCIENCE ASSESSMENT
A. Product Chemistry
o
II
OH-C-CH,-NH-CH?-PO,H,
£ t. iJ •=!
MGLCCULAn STTIUCTURi: Or GLYPIIOSA1I
-------
GLYPHOSA TE RED
September 1993
Empirical Formula:
Molecular Weight:
CAS Registry No.:
Shaughnessy No.:
C3H8N05P
169.07
38641-94-0
103601 (isopropylamine salt, IPA)
103603 (sodium salt)
B.
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 Ib/ft3.
Human Health Assessment
1. Toxicology Assessment
The toxicological 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)(i)
Acute Inhalation (i)
Result
> 4320 mg/kg
>2g/kg
Not Required
Category
III
III
N/A
1-MRPD 00067039
The following table is derived from MPs considered
toxicologically similar to glyphosate technical.
10
-------
GLYPHOSA TE RED
September 1993
Acute Toxicity
Test
Eye Irritation (i)
Dermal Irritation (2)
Skin Sensitization (3)
Result
mild irritation, clears in 7
days
slight irritation
negative
Category
III
IV
N/A
1-MRPD 41400603
2 -MRTD 41400604
3 - MRPDs 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 were 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. Based on the reduced
11
-------
GLYPHOSA TE RED
September 1993
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 10,
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)
c. 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 included: (1) In the females:
decreased body weight gains; and (2) In the males: increased
incidence of cataracts and lens abnormalities, decreased urinary
12
-------
GLYPHOSA TE RED
September 1993
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 > 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, 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 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
13
-------
GLYPHOSA TE RED
September 1993
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 ratherthan 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 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.
14
-------
GLYPHOSA TE RED
September 1993
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). Developmental 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 > 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)
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
15
-------
GLYPHOSA TE RED
September 1993
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,
F2a 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
-------
GLYPHOSA TE 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 typhimurium 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 E. coli 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-glyphosate 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 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
17
-------
GLYPHOSA TE RED
September 1993
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
-------
GLYPHOSA TE RED
September 1993
Other Toxicological 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 contains 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 toxicologically significant.
k. 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 (ADI) of 0.3 mg/kg body weight for glyphosate per se.
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 the high dose group. JMPR
19
-------
GLYPHOSA TE RED
September 1993
acknowledged that there is no effect at the highest dose tested in the
26-month rat study.
2. 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 perse.
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 perse.
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
-------
GLYPHOSA TE RED
September 1993
The available storage stability data indicate that residues of
glyphosate and its metabolite AMPA are stable under frozen storage
conditions (-20°C): in or on plant commodities 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
toxicity. Therefore, occupational and residential exposure data are
not required to support the reregistration of glyphosate. (For these
21
-------
GLYPHOSA TE RED
September 1993
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
eyewearfor 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 (REI) 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 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.
22
-------
GLYPHOSA TE RED
September 1993
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.
3. 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
well as tolerances recommended for 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
23
-------
GLYPHOSA TE RED
September 1993
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.
Guideline/Commodity
Referencesl
} 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
} 171 -4 (c) and (d): Residue Analytical Methods
\111-4 (e): Storage Stability
, 00036223,00036231,00037688,
, 00044423,00051982,00053002,
, 00061559,00063714,00065751,
00065752,00067425,00076805,00078823,00078824,
, 00108149,00108151,00108175,
, 00108231,00111945,00111949,
, 00164729,40502601,40541304
00028853,00036222, (
00038770,00038979, (
00053005,00060108, (
00108133,00108144,1
00108176,00108186, (
00122715,00159419,1
00039142,00040083,00051980,00053002,00061553,
00061555,00108129,00108132,40502605,40532004,
41940701
24
-------
GLYPHOSA TE RED
September 1993
Guideline/Commodity
Referencesl
§ 171 -4 (k) (1): Magnitude of the Residue in Plants
Root and Tuber Vegetables Group
- Artichokes, Jerusalem
- Beets, garden
- Carrots
- Chicory
- Horseradish
- Parsnips
- Potatoes
N/A
00108159
00108159
N/A
N/A
N/A
00108151,41947001
- Radish
- Rutabagas
- Salsify
- Sugar beets
00108159
N/A
N/A
00039381,00108151
- Sweet potato
- Turnips
Leaves of Root and Tuber
Vegetables Group
- Beets, greens
- Chicory leaves
- Sugar beet tops
- Turnip tops
Bulb Vegetables Group
-Garlic
- Onions (green and dry bulb)
Leafy Vegetables (except Brassica)
Group
- Celery
- Lettuce (head and leaf)
- Spinach
00108151
40835201
N/A
N/A
00039381,00108151
40835201
N/A
40783101
N/A
00108159
N/A
25
-------
GLYPHOSA TE RED
September 1993
Guideline/Commodity
Referencesl
Brassica Leafy Vegetables Group
- Broccoli
- Cabbage
- Cauliflower
-Kale
- Mustard greens
40802801,40802801
00108159
N/A
N/A
40802801,40802801
Legume Vegetables
(Succulent/Dried) Group
- Beans (succulent and dried)
- Lentils
- Peas (succulent and dried)
- Soybeans
(processed commodities)
00108159
00108159
00108159
00015759,00015760,00015761,00015762,00015763,
00015764,00015765,00015766,00015767,00024503,
00033954,00038908,00040084,00061555,00108153,
00108203
00061555,00108153,00156793
Foliage of Legume Vegetables
fSucculent/Dried') Group
- Bean vines and hay
- Lentil forage and hay
- Pea vines and straw
- Soybean forage and hay
00108159
00108159
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)
00039142
40159401
Pome Fruits Group
Stone Fruits Group
00108129
00111949
26
-------
GLYPHOSA TE RED
September 1993
Guideline/Commodity
Referencesl
- Plums (fresh prunes)
00111949
Small Fruits and Berries Group
- Blackberries
- Blueberries
- Cranberries
- Grapes
(processed commodities)
- Raspberries
Tree Nuts Group
- Almond hulls
00053002
00038770,00108132
40785303
00111945
00111945
Cereal Grains Group
- Barley
(processed commodities)
- Corn (field and fresh)
(processed commodities)
-Oats
(processed commodities)
-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
00038908,00040087,00044422,00108203
N/A
00023336,00023512,00037687,00038908,00040085,
00048284,00108203,40502602
40502604,41478101
00038908,00040087,00044422,00108203
N/A
00038908,00040087,00044422
N/A
N/A
N/A
00038908,00040087,00044422,00108203,00109271,
40502601
40502603
00038908,00040086,00044426,00108203,00122715,
41484301
00150835
00038908,00040087,00044422,00108203
27
-------
GLYPHOSA TE RED
September 1993
Guideline/Commodity
Referencesl
- Corn forage and fodder
- Oat forage, hay, and straw
- Rice straw
- Rye forage and straw
- Sorghum forage and fodder
- Wheat forage and straw
Grass Forage. Fodder, and Hay
Group
Non-grass Animal Feeds (forage,
fodder, straw, and hay) Group
- Alfalfa seed
00023336,00023512,00037687,00038908,00040085,
00048284,00108203,40502602
00038908,00040087,00044422,00108203
00038908,00040087,00044422
N/A
00038908,00040087,00044422,00108203,00109271,
40502601
00038908,00040086,00044426,00108203,00122715
00076805,00108147
00076805,00108147
40541304
Miscellaneous Commodities
- Acerola
- Atemoya
- Asparagus
- Avocados
- Bananas
- Breadfruit
- Canistel
- Carambola
- Cherimoya
- Cocoa beans
- Coconut
- Coffee beans
- Cotton
(processed commodities)
- Dates
-Figs
-Genip
- Guavas
- Jaboticaba
- Jackfruit
00108144,40642401
00108149
00108175
40149401
40149401
00051980,00051981
00060103,00061553,00108176,00108153,00108203
00061553,00108176,00108153
40149401
00059050
40149401
40149401
28
-------
GLYPHOSA TE RED
September 1993
Guideline/Commodity
Referencesl
- Kiwi fruit
- Litchi Nut (Lychee)
- Longan
- Mamey Sapote
(Mammee Apple)
- Mangoes
-Okra
- Olives
(processed commodities)
- Palm oil
- Papayas
- Passion Fruit
- Peanuts
(processed commodities)
- Persimmons
- Pineapple
- Pistachio
- Sapodilla
- Sapote (black and white)
- Soursop
- Sugar apple
- Sugarcane
(processed commodities)
- Tamarind
- Tea
- Watercress
§ 171 -4 (h): Magnitude of the
Residue in Plants Resulting from
the Use of Irrigation Water
§171-4 (j): Magnitude of the Residue in Meat, Milk, Poultry,
and Eggs
§ 171 -4 (g): Magnitude of the
Residue in Fish
40580401
N/A
00108175,42398401
00108175,42398401
00063713
00144341,00028852
00144341,00028852
40149401
N/A
00111945
40149401
40149401
00108140
00108168
40149401
00078823,00078824
N/A
00039381,40541305
00108115,40532001-03
00036229,00076491,00154311,00155120
29
-------
GLYPHOSA TE RED
September 1993
Guideline/Commodity
Referencesl
§ 171 -4 (f): Nature and Magnitude
the Residue in Drinking and
Irrigation Water
§171-4 (i): Magnitude of the
Residue in Food Handling
Establishment
§171-5: Reduction of Residues
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 Reregistration Support (CBRS# 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
Glyphosate 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. (MRID
41689101)
(3) Photodegradation on Soil
(4)
Glyphosate is stable to photodegradation on soil.
(MRID 41335101)
Aerobic Soil Metabolism
30
-------
GLYPHOSA TE RED
September 1993
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 silty 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 was 93-100% of the
applied material. (Accessions 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 the 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.
31
-------
GLYPHOSA TE RED
September 1993
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 (DT50) 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 all 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
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
32
-------
GLYPHOSA TE RED
September 1993
the lack of a significant amount of rainfall between sampling
intervals in combination with the amount of time between
sampling intervals and the high absorptive 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 were
<0.05 ppm in the 6-12 inch soil layer. In New York at 14 and
30 DAT average residues were detected 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 (DT50) (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 142 days
! California 958 days
! Georgia 896 days
! Minnesota 302 days
33
-------
GLYPHOSA TE RED
September 1993
\ New York 240 days
! Ohio 119 days
! Texas 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)
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 >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
34
-------
GLYPHOSA TE RED
September 1993
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, [14C]residues were 0.108 and 0.048
ppm, 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 at28 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
35
-------
GLYPHOSA TE RED
September 1993
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
-------
GLYPHOSA TE 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(ads) 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 C02, 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
-------
GLYPHOSA TE 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
Species
Bobwhite
quail
% AI
83%
LD50 (95% CL)
> 2000 mg/kg
Conclusions
practically non-toxic to upland game birds
One avian single-dose oral study on either a waterfowl species (preferably mallard duck) or an upland
species (preferably bobwhite quail) was required. These data indicate that technical glyphosate is
practically non-toxic to an upland bird species on an acute oral basis. The guideline 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 mallard duck) and one on
an upland game bird species (preferably a bobwhite quail), were required. These data indicate that the
technical glyphosate is no more than slightly toxic to birds on a dietary basis. The guideline requirement
is fulfilled for both studies. (Study IDs 94171 and 00086492)
38
-------
GLYPHOSA TE RED
September 1993
(c) Avian Reproduction
Avian Reproduction Findings
Species
Mallard duck
Mallard duck
Bobwhite
quail
% AI
83%
Tech
90.4%
Tech
83%
Tech
Reproductive
Impairment
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 that technical glyphosate is not expected to cause reproductive impairment The
guideline requirements 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 LD50
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
LC50 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
-------
GLYPHOSA TE RED
September 1993
(2) Effects on Non-Target Fish
(a) Acute Toxicity to Freshwater Fish
Acute Toxicity to Freshwater Fish Findings
Species
% AI
48-hr LC50
(95%CL)
Conclusions
Bluegill sunfish
96.5%
• 24 mg/1
Fathead
Minnow
87.3%
84.9 mg/1
(72.9-99.3)
ranges in toxicity from slightly non-toxic to practically non-toxic
to both cold water and warm water fish
Bluegill sunfish
83%
120 mg/1 (111-
130)
Rainbow Trout
83%
86 mg/1 (70-
106)
Rainbow Trout
96.7%
140 mg/1 (120-
170)
Fathead
minnow
96.7%
97 mg/1 (79-
120)
Channel catfish
96.7%
130 mg/1 (110-
160)
Bluegill sunfish
96.7%
140 mg/1 (110-
160)
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 on freshwater fish is fulfilled. (Study IDs 00108112,00108171,
234395,097661, and 249160)
40
-------
GLYPHOSA TE RED
September 1993
(b) Chronic Toxicity to Freshwater Fish
Chronic Toxicity 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
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 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
Species
Bluegill
sunfish
Rainbow
Trout
Channel
catfish
Rainbow
Trout
Bluegill
sunfish
Fathead
Minnow
Rainbow
Trout
Bluegill
sunfish
Rainbow
Trout
%AI
(TPA salt)
41.8%
41.8%
41.36%
41.36
41.36%
41.36%
62.4%
62.4%
*41.2% +
15.3 "AA"
surfactant
96-hr LC50
(95% CL)
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 (8.7-14)
14 mg/1 (8.7-24)
9.4 mg/1 (5.6-16)
> 1000 mg/1
>1000mg/l
120 mg/1 (56-180)
Conclusions
ranges in toxicity from moderately toxic to practically non-
toxic to both warmwater and coldwater fish
41
-------
GLYPHOSA TE RED
September 1993
Acute Toxicity to Freshwater Fish
Findings from Studies using Formulated Products
Rainbow
Trout
Bluegill
sunfish
Bluegill
sunfish
Rainbow
Trout
Bluegill
sunfish
Rainbow
Trout
Fathead
minnows
Rainbow
Trout
Bluegill
sunfish
Channel
catfish
Bluegill
sunfish
Rainbow
Trout
*40.7% +
15%"W"
surfactant
*40.7% +
15%"W"
surfactant
*41.2% +
15.3%
"AA"
surfactant
7.03% +
0.5% "X-
77"
7.03%+
0.5% "X-
77"
51%
41%
41%
41%
41%
41%
41%
150 mg/1 (100-
320)
>100mg/l
>180mg/l
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)
Testing 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,
42
-------
GLYPHOSA TE RED
September 1993
00070895,00070897,00070896,00078661,00078662,00078658,00078655,00078656,00078659,
00078664, 00078665,249160)
Surfactant Test Findings
Species
Fathead
minnow
Rainbow
trout
Rainbow
Trout
Channel
Catfish
Bluegill
sunfish
Bluegill
sunfish
% AI
MONO818
Tech 100%
MONO818
Tech 100%
MON0818
MON0818
Tech 100%
MONO818
Tech 100%
MONO818
Tech 100%
96-hour LCSO
(95% CL)
1.0 mg/1 (1.2-
1.7)
2.0 mg/1 (1.5-
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)
(c) Summary of Findings
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 LC50s provided values of 86 ppm and
140 ppm. Based on these tests, technical glyphosate
ranges 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 an application rate much
43
-------
GLYPHOSA TE RED
September 1993
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 LC50
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 LC50 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 LC50 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 LC50 values of 150 and >100 mg/l,
respectively. Also, neither rainbow trout (LC50 240
mg/l) nor bluegill (LC50 830 mg/l) were very sensitive
to the x-77(.5) surfactant and glyphosate(7.03%).
The surfactant MON0818 has been tested
separately, producing an LC50 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 LC50 value of 0.65 mg/l. Based
upon available data products containing MON08I8
must include the statement, "This pesticide is toxic to
fish."
44
-------
GLYPHOSA TE RED
September 1993
(3) Effects on Aquatic Invertebrates
(a) Acute Toxicity to Freshwater Invertebrates
Acute Toxicity to Freshwater Invertebrates Findings
Species
Daphnia magna
Chironomus
plumosus
% AI
83% tech
96.7%
tech
48-hr LCSO (ppm)
780
55(31-97)
Conclusions
ranges in toxicity from slightly toxic to
practically non-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 fulfil led.
(Study ID 00108172, and 249160)
(b) Chronic Toxicity to Freshwater Invertebrates
Chronic Toxicity to Freshwater Invertebrates Findings
Species
Daphnia magna
%AI
99.7%
tech
Results
MATC > 50 -<
96mg/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 249160)
Acute Toxicity to Freshwater Invertebrates
Findings from Studies using Formulated Products
Species
% AI
(IPA salt)
48-hr LC50
(ppm)
Conclusions
Daphnia magna
62.4%
869 (703-
1019s!
ranges in toxicity from moderately toxic to practically non-toxic
45
-------
GLYPHOSA TE RED
September 1993
Acute Toxicity to Freshwater Invertebrates
Findings from Studies using Formulated Products
Daphnia magna
Daphnia magna
Daphnia magna
Daphnia magna
Gammarus
pseudolimnaeus
Chironomus
plumosus
Daphnia pulex
Daphnia magna
Gammarus
pseudolimnaeus
Ephemerella
'walker i
7.03% +
X-77
surfactant
@0.5%
41.2% +
"AA"
surfactant
@ 15.3%
40.7%
MON2139
+ 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
1112/1
46
-------
GLYPHOSA TE RED
September 1993
Acute Toxicity 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 by 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 LC50
(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 LC50 of 780 ppm (mg/1) 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.
In addition to these acute studies, a fish life-
cycle study indicates technical glyphosate has a
47
-------
GLYPHOSA TE RED
September 1993
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 LC50 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 LC50 was 310
ppm which would indicate it is practically non-toxic to
Daphnia. The third combination consisted of 40.7
percent isopropylamine and 15 percent of a surfactant
identified as "W." The resultant LC5o 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
-------
GLYPHOSA TE 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 LC50) 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
Results
Conclusions
Grass shrimp
96.7%
tech
LC50 281 ppm
(207-381)
ranges in toxicity from slightly to practically non-toxic to
marine organisms
Fiddler crab
96.7%
tech
LC50 934 ppm
(555-1570)
Atlantic oyster
96.7%
tech
TL50>10mg/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 slightly toxic to the
Atlantic oyster. Acute toxicity testing on an estuarine fish species is normally required. However, since
there is such an extensive data set for this chemical, the Agency can determine that glyphosate
49
-------
GLYPHOSA TE RED
September 1993
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 LC50 of 281 ppm was
determined for grass shrimp (Palaemonetas
vulgar!s). In a study on fiddler crabs (Uca pugilator),
it was determined that the 96-hour LC50 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 TL50 for
Atlantic oyster greater than 10 ppm indicating
glyphosate is slightly toxic.
(5) Effects on Non-Target Insects
(a) Acute Toxicity Testing
Acute Toxicity to Honeybees Data
Species
Honeybee
acute oral
Honeybee
acute oral
Honeybee
acute contact
Honeybee
acute contact
AI%
tech*CP67573
36%MON2139
tech*CP67573
36%MON2139
Results
oralLD50>
lOO^g/bee
oralLD50>
lOOug/bee
contact LD50 >
lOO^g/bee
contact LD50 >
100ng/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 acute oral toxicity. These data
satisfy guideline requirements for nontarget insect studies when glyphosate is used as a general use
herbicide. (Fiche No. 00026489)
50
-------
GLYPHOSA TE RED
September 1993
(b) Summary of Findings
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 LD50 values greater
than 100 ug/bee. Results from the honeybee acute
contact toxicity study indicates both technical and
formulated glyphosate are practically nontoxic to the
honey bee with LD50 values greater than 100 ug/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
Species
Selenastrum
capricornutum
Navicula
pelliculosa
Skeletonema
costatum
Anabaenaflos-
aquae
Lemnagibba
%AI
96.6
96.6
96.6
96.6
96.6
Results
4 day EC50 = 12.5
mg/1
4 Day EC50 = 39.9
mg/1
4 day EC50 = 0.85
mg/1
4dayEC50 = 11.7
mg/1
7dayEC50 = 21.5
mg/1
Based on the results of the preceding studies, the data indicates that the 4 day EC50 ranged from 0.85 mg/1
to 39.9 mg/1 for four aquatic plant species, and a 7 day EC50 of 21.5 mg/1 for one aquatic species. Based
51
-------
GLYPHOSA TE RED
September 1993
on the data submitted, the requirements for Tier I and Tier H 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. (MRIDs 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 EC50 ranged from 0.85 mg/l to
39.9 mg/l for four aquatic plant species, and a 7 day
EC50 of 21.5 mg/l for one aquatic species.
Aseed 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 Ib
ai/A resulted in <25 % effect on the spectrum of
monocots and dicots tested.
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 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
52
-------
GLYPHOSA TE RED
September 1993
reregistration eligibility of glyphosate. 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.
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 (LC50 > 4640). The articles of Hoerger
and Kenaga (1972) and Kenaga (1973) were
consulted in order to estimate the maximum
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)
<2> 5.0625 Ibs ai/A
Short grass I 1215
53
-------
GLYPHOSA TE RED
September 1993
Long grass
Leafy crops
Forage; small insects
Pods; large insects
Fruit
557
632
294
61
35
Comparing these residues to the dietary data for both
bobwhite and mallards (LC50 > 4640; 1/5th the LC50 > 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
-------
GLYPHOSA TE 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 LC50 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 LC50s 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.
(c) Terrestrial Plants and Aquatic Macrophytes
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 Ib
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 10.0lba.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)
No vegetative vigor (123-1) plant studies have
been conducted. Based on the use patterns, the
method of application and the chemical properties of
55
-------
GLYPHOSA TE RED
September 1993
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 LC50, aquatic
organisms= 1/20 LC50). 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.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
56
-------
GLYPHOSA TE RED
September 1993
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 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.
57
-------
GLYPHOSA TE RED
September 1993
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
tolerancesfor 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 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,
58
-------
GLYPHOSA TE RED
September 1993
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 0; 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
(exceptsoybeans) 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
-------
GLYPHOSA TE 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 tolerancesfor"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.
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.
60
-------
GLYPHOSA TE RED
September 1993
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 per se 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.
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
61
-------
GLYPHOSA TE RED
September 1993
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.
A12-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).
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.
62
-------
GLYPHOSA TE RED
September 1993
Commodity
Current Tolerance '
(ppm)
Tolerance 2
Reassessment (ppm)
Comment/Correct Commodity
Definition
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
Bahiagrass
Bermudagrass
Bluegrass
Bromegrass
Fescue
Forage grasses
Grasses, forage
Orchardgrass
Ryegrass
Timothy
Wheat grass
Bananas
Beets
Beets, sugar
Breadfruit
Canistel
Carambola
Carrots
Cherimoya
Chicory
Citrus fruits
Cocoa beans
Coconut
Coffee beans
Cotton, forage
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
1
15
Revoke and establish at
100
Revoke and establish at
100
Revoke
Revoke
Revoke
Revoke
Revoke
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
Coffee beans, green
63
-------
GLYPHOSA TE RED
September 1993
Commodity
Cotton, hay
Cottonseed
Cranberries
Dates
Figs
Forage grasses
Grasses, forage
Fruits, small and berries
Genip
Grain crops
Grapes
Guavas
Horseradish
Jaboticaba
Jackfruit
Kiwifruit
Leafy vegetables
Longan
Lychee
Mamy sapote
Mangoes
Nuts
Olives
Papayas
Parsnips
Passion fruit
Peanut, forage
Persimmons
Current Tolerance !
(ppm)
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
0.5
0.2
Tolerance 2
Reassessment (ppm)
Revoke
Revoke
Revoke
0.2
Revoke
Revoke
Revoke
Revoke
0.1
Revoke
Comment/Correc/ Commodity
Definition
Not in Table II, Subdivision O,
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
Peanuts, vines
No registered uses
64
-------
GLYPHOSA TE RED
September 1993
Commodity
Pineapple
Pistachio nuts
Pome fruits
Potatoes
Radishes
Rutabagas
Salsify
Sapodilla
Sapote, black
Sapote, white
Seed and pod vegetables
Seed and pod vegetables,
forage
Seed and pod 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
Wheat, grain
Wheat, straw
Current Tolerance !
(ppm)
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
N/A
N/A
Tolerance 2
Reassessment (ppm)
Revoke
Revoke
Revoke
5
0.2
Revoke
200
Revoke
Revoke
5.0
85 (proposed)
Comment/Correc/ Commodity
Definition
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 II, Subdivision O,
PAG
Stone fruits group
No registered uses
Turnips, roots
Bulb vegetables group
Cucurbit vegetables group
Fruiting vegetables group
Brassica leafy
vegetables group
see Codex harmonization Table
65
-------
GLYPHOSA TE RED
September 1993
Commodity
Current Tolerance !
(ppm)
Tolerance 2
Reassessment (ppm)
Comment/Correc/ Commodity
Definition
Tolerances listed under 40 CFR §180.364(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
Grain crops
Hops
0.1
0.1
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
Cereal grains group
and
Forage, fodder, and straw of
cereal grains group
66
-------
GLYPHOSA TE RED
September 1993
Commodity
Leafy vegetables
Nuts
Pome fruits
Root crop vegetables
Seed and pod vegetables
Stone fruit
Current Tolerance !
(ppm)
0.1
0.1
0.1
0.1
0.1
0.1
Tolerance 2
Reassessment (ppm)
Comment/Correc/ Commodity
Definition
Leafy vegetables (except
Brassica) group
and
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 II, 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
1 Tolerances are for the combined residues of glyphosate and its metabolite AMPA.
2 Tolerances are now for glyphosate per se.
67
-------
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
Beans (dry)
Cattle meat
Cattle milk
Cattle, edible offal
Cottonseed
Eggs
Hay or fodder (dry) of grasses
Kiwifruit
Maize
Oats
Peas (dry)
Pig meat
Pig, edible offal
Poultry meat
Rape seed
Rice
MRL (Step)
(mg/kg)
20 (CXL)
2 (CXL)
0.1
(CXL)
0.1
(CXL)
2 (CXL)
0.5
(CXL)
0.1
(CXL)
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)
U.S. Tolerance
(ppm)
0.1 (Cereal grains group, except wheat)
0.2 (Legume vegetables group, except
soybeans)
0.5 (Cattle, liver & kidney)
15
100 (Grass forage, fodder, and hay
group)
0.2
0.1
0.1 (Cereal grains group, except wheat)
0.2 (Legume vegetables group, except
soybeans)
0.5 (Hogs, liver & kidney)
0.1 (Cereal grains group, except wheat)
Recommendation
increase U.S. tolerances
decrease U.S. tolerance
increase U.S. tolerance
increase U.S. tolerances
68
-------
Commodity
Sorghum
Soya bean fodder
Soya bean forage (green)
Soya bean (dry)
Soya bean (immature seeds)
Straw and fodder (dry) of cereal grains
Sweet corn (corn-on-the-cob)
Wheat
MRL (Step)
(mg/kg)
0.1
(CXL)
20 (Step 8)
5 (Step 8)
5 (Step 8)
0.2
(CXL)
100 (CXL)
0.1
(CXL)
5 (CXL)
U.S. Tolerance
(ppm)
0.1 (Cereal grains group, except wheat)
15 (Soybeans, hay)
15 (Soybeans, forage)
20 (Soybeans)
0.2 (Forage, fodder, and straw of cereal
grains group, except wheat straw)
0.1 (Cereal grains group, except wheat)
4 (proposed)
Recommendation
increase U.S. tolerance
Wheat bran, unprocessed
Wheat flour
Wheat whole meal
40 (Step 6)
0.5
(Step 8)
5 (Step 8)
12 (proposed)
12 (proposed)
proposal
increase U.S. tolerance
proposal
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.
69
-------
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. tolerances exist; and (ii)
Codex MRLs have been established, but U.S. tolerances do not exist.
2. Labeling Rationale
While studies show that glyphosate is no more than slightly toxic to birds 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
The 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
70
-------
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 glyphosate and do not affect the
reregistration eligibility of glyphosate. (See Appendices for the Generic Data Call-In
Notice.)
Name of Study
Tier II 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
All 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
71
-------
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, 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 CFR §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
72
-------
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 93-11 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 sold 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 (REI)
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 Primarily Intended for Home Use: For products primarily 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 glyphosate
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
-------
1. Boldedreferences were reviewed on 4/26/90. Unbolded references were reviewed in the Residue Chemistry
Science Chapter of the Reregistration Standard dated 7/15/85. Otherwise, references were reviewed as noted.
75
-------
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 P.
-------
i
-------
I
i,
8 i
! i
I* I
8
i
m
6
i i i
I
I i i I I
i ! 1
1 ! 1
! I I M
i !
i 1
i
s
i
i
I
I i i
I I I
a* *
s i
i i
-------
lOltgt . OlfphoMt*, iMprapfiMlw nit,
•It*.
vaim
tiMioai *«port
•It* MM! DM Group*
D*t*i 05 JtfL IMS
p»t»t a
m* OrfMB*
M* Amp C**»f*if DM*.
•LftCMBWf
rooo CHOP
MAUL HUT
MEAOntUlT (tHBAtrnVT)
MUUIU IPIOUT*
BUCRNHBAT
CAIMGK, omn
CWUUKMR>tH
CMAKBOLA f JJU.U)
CMMOT IIMCtADIIIO TOM)
CMHZV
Pood/PMd «•••
CHOf
PMd^PMd 0*M
Pood/PMd D*M
POO04V8KD CROP
wimHnEiixm> POOD
TtMUnmilAl. MODMVB CHOP
nmntfRiu. POOO «»OP
9VKKBKMSIIE* POOD CHOP
CELKRt
P00d/P**i O»M
Pood/PMd VM*
POOd/P*** MM
Poed/PMd VIM
Pooi/)P**4 ••••
POOd/PMrf 8*M
M«»
-------
IOJCDI - OlfphoMt*, Imafropjlmmln* unit
LOW
Q*n*tal Chmicil Rwort
•it* •Ml V*« Ortrnpi
05
CHARD, *«»•
CftBRINOTJk
0** droop.,.»**«***»**
^fWIHBOTHIfcl* FOOD CfNM*
POOD CWW
POOD CROff
«•••
Poad/PMli ?' M
»•••
cmcoRf
CStftON (CITRUB)
CITHOB HTMIM onrm THAU «UMIU>
COCOA
ctvrn
COTJJWOS
CROP
CROP
Paod/r**d «•••
PO09 CROP
MI> POOD CROP
"COM
imnrecsriBDi
f JI&
IWL
CROP
CROP
CORD, rnutt
COTTON
ciuuiinmi
CRKfl, Ml'BR
COCWDBR
CURRJUR
DHtt
t IHL POOD+PHU) CROP
t IkSi POOtM>PWD CROP
POOO CROP
tmnMnau. POOD CROP
f00H ^no|i
p VOOfi C9KHP
fMfltmitjUpti wwo cw>p
MM
MM
MM
MM
MM
-------
I
s .
il
.1:
"
i
1
1
*»
*
i
i
i I
: s
£ S
I
1
i ':
I I
i
M
t
!
lllllllllll
i
! I I S 8 I I I 8 S 8 I I
i i i ! i ! i i I i I I I
iiiiiiiiiiiti
i i i i i
ll
§ i
\ i i
: I
-------
i
&
•r
41
4
£
j
i
t
i i
IK ,
t O 1
. S . £
»"* «p* »
IIs !
S 1 a
• *
h 4»
J3
• f • m
> • • • *
> S 2 5 2
[ ! 2 1 1
>. ^ %» •«»
! S i
s | a g
b JJ m M »*
•
&
i i i &
§ 1 S i
5
s
! i
s i
e §
iiiii
i i §
£ ! I
i I i
I i i
s
s
m
I
i
s
:
i i S i i
I i
i
i
-------
i
J 8.
S i
D
*
U
I
II .
l\ I
I
8 ! 8
2 2 £
i ! i i I I I i i I i
1 I I I ! I I I I I I I ! 1] I ! !
I
S *
I E
i
1
I
|
I
i
i i i i 1 §
C 6 S C % C
If!!
i i i i
i i
i
i
I
£
i
-------
i
£ I
S I I
III
§
i I
|
i
•
!i
• 8 « i
M *! •
3lf '<
•p
I I I I 1 I
I I I I I I
! i 8 1 1 1
A A A A A A
! 8 I 1 1 I
t t i i i a
M M |Pl M «M M
|
1 . .
I
S
I i
- C
S I
8 £
I I I
i g i i s
I I I I
I I I I
1112
8
i I
i i
i i
d d
-------
i
*
H
- S
6 m
8 S
I
«M
i
I I I I I I I I ! i I I I 1 i I i I
I 1 I! I I ! I I I I I I 1 I I I I
W
i
i
$33332323
i I i i
I
I i
s a
-------
!
z i
I 2
i
I
I
-
\l •
o
•
| 1 f
j i i
I § § I I §
inn
- ~ S
e
§
s
s
8 .
S . E
1 I I
i i i i i i
S n »«
-------
IOKOI .
«*
TKITfCALB
wnn
inn
imct(LTI«T«t> MEM
AQUATIC
mtt tuunKrtom
OMIPHI RBLKASB
LOU
*Mrai Ckmlcal *«f>ort
•it* ind «•• Group*
D«t«i OS JOT, IttS
»«• Oroup.......................... VM anup OtMory D««e.
pood/PMd MM
Peed/PMd MM
mtunniu. pooiHPno CMP Peod/pMd MM
WOO CMt
mmtmtut, POOD+PMO CHOP Poorf/Pm) Mf
Peod/PMd «••
Poed/PMd
tmusiiitJiti ram CHOP
Paod/P*«l ****
muwmtiu.
ttnmftiM. MN-naD CHOP
BOH-FOOO CHOP
MM.POOD
AQVATIC MOH-rOOO OUTUOOIt
RMKNHXMi MOM-POOD CHOP
•on-Pood/Hon-PMd VBM
MM-P«atf/HM-PMd «M*
*Mi-Paad/llM-r*«d VIM
«•••
Moa-Pood/P.cm-P*«d
-------
io MO I
•it*.. ........ , .............. . ............
poRin momma (MFOMBTWIOH PROGRAMS)
man nuns (WA ot umractrsini
COLT COOMB TOR*
MUBMRHItt-IMPTf
ROWtMOlD/DOMISTtC DmttlMO* OUTDOOR mNl*M
tNMISfRIiU. ARKAS fOOTDOOR)
to
NONAGXICULTUIUU.
IWNAGKICVLTVlua WCULTIVATTO JUUtM/BOIU
onuuamu. HMD/OK IRADC HUBS
»'
NMOITTML MfO/ON CHAM TWWS
AHD/OR sinra' nina
HEIUMCBOUB ruum
unms wto TURT
OMtMKIirU. LAW* AMD TW
ORMUmnkl. MOOT •HRttM JMD VtRU
OMMBItTM. WOODf SMIIfM MID VtHM
NOODT IMIUU Ann vims
Ult*
0*n*ml Chwileal Report
wid V«* Oroupi
Dmt«i 0» JVI. lit I
«•* armip.
0m Group Cat*fBty IMIO.
Kon-Pont/llaa-PMrf «•••
0***
YnuamuM. ww-rooo CIWF
INDOOR
Mniotmuit,
MM-POOO
M«l-Pood/Ron-P*«d
Otct
MR-MOD CROP
Ran-Pix>d/Hon-P*«l
•on-Paod/Ho«.r*«i
MH-POOD CROP »o«-Po«i/*on-P««<» Of*(
TBIUUtmilAL HM-POOO«OOIIKNM RHIM Ro«-Pood/lloo-P««l «•••
HOH-POOD CRO •ott
RMIM »a«.peod/iion-pMd «•*•
ROH-POOO CROP
lhMi-Paod/»on-P««i
Von-Pood/Rfin-P»«4
MOW-POOD CTO Ron-Poorf/llon-PMd »•••
-------
S I
& I
i
4
1
1
i
i
i
«
4
*#
& 1
I i c
>• :
t * \
** **4 •
•I,' 1
1«
•H
«4
•
•
I
!
«•
f
•
I
i
t
•w
e
*
***
e
i : s s
1125
: ! 1 I !
H H
Ml!
i i i i
i
1 i e «
§ § 1 |
?« K e
B M ^
* 8 S
tie*
* T 1
I i ! §
,
i
|
. i § §
s 1 i 1
1 1 I -
III *
1
I
1
i
1
i
i
I
i
§
-------
i
i
** »*
if
t
. :
555
1
*
11
5 i
s I I
i
8 8
IU 141
Ik tk
* *
I §
.= !*
s» • 5
1
S 2
S
1
1
8
S .
r s
-------
i
-------
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 glyphosate 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 Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR, Part
158. The reference numbers accompanying each test refer
to the test protocols set 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
patterns:
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
0 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.
-------
Data Supporting Guideline Requirements for the Reregistration of Glyphosate
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-2A Start. Mat. & Mnfg. Process
61-2B Formation of Impurities
62-1 Preliminary Analysis
63-2 Color
63-3 Physical State
63-4 Odor
63-5 Melting Point
63-6 Boiling Point
63-7 Density
63-8 Solubility
63-9 Vapor Pressure
63-10 Dissociation Constant
63-11 Octanol/Water Partition
63-12 pH
63-13 Stability
63-17 Storage stability
all
all
all
all
all
all
all
all
all
all
all
all
all
all
all
AC
00161333
00161333
40405401,00161333
00161333
00161333
00161333
00161333
00161333
00161333
00161333
41096101,00161333
00161333
00161333
00161333
00161333,40559301
41573601, 00039142, 00061553,
00040083, 00061555, 00051980,
00108129, 00053002, 00108102
-------
Data Supporting Guideline Requirements for the Reregistration of Glyphosate
REQUIREMENT
USE PATTERN
CITATION(S)
ECOLOGICAL EFFECTS
71 -1A Acute Avian Oral - Quail/Duck
71-2A Avian Dietary - Quail
71-2B Avian Dietary - Duck
71-3 Wild Mammal Toxicity
71-4A Avian Reproduction - Quail
71-4B Avian Reproduction - Duck
72-1A Fish Toxicity Bluegill
72-1B Fish Toxicity Bluegill - TEP
72-1C Fish Toxicity Rainbow Trout
72-1D Fish Toxicity Rainbow Trout -
TEP
72-2A Invertebrate Toxicity
72-2B Invertebrate Toxicity - TEP
72-3B Estuarine/Marine Toxicity -
Mollusk
ABCDFGH
ABCDFGH
ABCDFGH
ABCDFGH
ABCDG
ABCDG
ABCDFGH
ABCDG
ABCDFGH
ABCDG
ABCDFGH
ABCDG
ABCD
00108204
00108107
00076492
00076492
00108207
00036328,00111953
00136339, GS-0178025
15296, 152599, 152601, 152767
00108112,00108205
00070895, 00078661, 00070897,
00078662, 00078655, 00078664,
00078656, 00078665, 00078658,
00108205, 00078659, 00124760,
GS0178025, 5298, 152766, 152903,
155477
00108172
00070893, 00078666, 00078657,
00124762, 00078660, GS0178025,
0078663, 152597, 152600, 152602, 152768
00108110
-------
Data Supporting Guideline Requirements for the Reregistration of Glyphosate
REQUIREMENT
USE PATTERN
CITATION(S)
72-3C
72-4B
72-5
122-1A
122-2
Estuarine/Marine Toxicity -
Shrimp
Life Cycle Invertebrate
Life Cycle Fish
Seed Germination/Seedling
Emergence
Aquatic Plant Growth
ABCD
ABCDGH
ABCDGH
BDG
BDG
00108111
00124763
00108171
40159301
40236901 , 40236902, 40236903,
123-2
Aquatic Plant Growth
141 -1 Honey Bee Acute Contact
TOXICOLOGY
81 -1 Acute Oral Toxicity - Rat
81-2 Acute Dermal Toxicity-
Rabbit/Rat
81-4 Primary Eye Irritation - Rabbit
81-6 Dermal Sensitization - Guinea
Pig
82-1A 90-Day Feeding - Rodent
82-2 21 -Day Dermal - Rabbit/Rat
83-1A Chronic Feeding Toxicity -
Rodent
BDG
ABGH
ABCDFGH
ABCDFGH
ABCDFGH
ACDFH
40236904, 40236905
40236901, 40236902, 40236903,
40236904, 40236905
00026489
00067039,41400601
00067039,41400602
41400603,41400604
00137137, 00137138, 00137139, 00137140
00036803, 40559401
00098460
00098460, 00093879
-------
Data Supporting Guideline Requirements for the Reregistration of Glyphosate
REQUIREMENT
USE PATTERN
CITATION(S)
83-1 B
83-2A
83-2B
83-3A
83-3B
83-4
84-2A
84-2B
84-4
85-1
Chronic Feeding Toxicity - Non-
Rodent
Oncogenicity - Rat
Oncogenicity - Mouse
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Gene Mutation (Ames Test)
Structural Chromosomal
Aberration
Other Genotoxic Effects
General Metabolism
ACDFH
ACDFH
ACDFH
ABCDFGH
ABCDFGH
ACDH
ABCDFGH
ABCDFGH
ABCDFGH
ACDFGH
00162912,
41728701,
00130406,
00046362
00046363
00081674,
00078620,
00046364,
00078619,
40767101,
41728701,00153374
41643801,00093879
00150564
00105995,41621501
00132683
00132681,00132685
00132686,00132685
40767102
ENVIRONMENTAL FATE
161-1
161-2
161-3
162-1
162-3
162-4
163-1
Hydrolysis
Photodegradation - Water
Photodegradation - Soil
Aerobic Soil Metabolism
Anaerobic Aquatic Metabolism
Aerobic Aquatic Metabolism
Leaching/Adsorption/
ABCDFGH
ABCDG
AG
ABFGH
CD
CD
ABCD
00108192
41689101
41335101
42372501
42372502
42372503
00108192
Desorption
-------
Data Supporting Guideline Requirements for the Reregistration of Glyphosate
REQUIREMENT USE PATTERN CITATION(S)
164-1 Terrestrial Field Dissipation ABH 42765001
164-2 Aquatic Field Dissipation CD 42383201
164-3 Forest Field Dissipation G 41552801
165-1 Confined Rotational Crop AC 42372504,41543201,41543202
165-3 Accumulation - Irrigated Crops CD 42372505,40541305
165-4 Bioaccumulation in Fish ABCDG 41228301
RESIDUE CHEMISTRY REFERENCES ARE CONTAINED IN THE BODY OF THE RED UNDER SECTION III, B
-------
Appendix C
Citations Considered to be Part of the Data Base
Supporting the Reregistration of Glyphosate
-------
GUIDE TO APPENDIX C
CONTENTS OF 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.
UNITS OF ENTRY. The unit of entry in this bibliography is
called a "study". In the case of published materials, this
corresponds closely to an article. In the case of unpublished
materials submitted to the Agency, the Agency has sought to
identify documents at a level parallel to the published article
from within the typically larger volumes in which they were
submitted. The resulting "studies" generally have a distinct
title (or at least a single subject), can stand alone for
purposes of review and can be described with a conventional
bibliographic citation. The Agency has 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.
C-1
-------
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 as the
author. When no author or laboratory could be identified,
the Agency has shown the first submitter as the author.
b. 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.
c. 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.
d. Trailing Parentheses. For studies submitted to the Agency
in the past, the trailing parentheses include (in addition
to any self-explanatory text) the following elements
describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received".
(2) Administrative Number. The next element immediately
following the word "under" is the registration
number, experimental use permit number, petition
number, or other administrative number associated
with the earliest known submission.
(3) Submitter. The third element is the submitter. When
authorship is de-faulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The final
element in the trailing parentheses identifies the
EPA accession number of the volume in which the
original submission of the study appears. The six-
digit accession number follows the symbol "CDL",
which stands for "Company Data Library". This
accession number is in turn followed by an alphabetic
C-2
-------
suffix which shows the relative position of the study
within the volume.
C-3
-------
00015759 Kahrs, R.A.; Cheung, M.W. (1979) Tank Mixes of Metolachlor (
plus Linuron or Metribuzin plus Glyphosate--Soybeans; Tank M
of Metolachlor (8E) plus Linuron or Metribuzin plus Paraquat
Soybeans: No and Minimum Tillage Applications: Report No. AB
79029. Summary of studies 237821-B through 237821-Q. (Unpub-
lished study received Mar 16, 1979 under 100-583; submitted
Ciba-Geigy Corp., Greensboro, N.C.; CDL:237821-A)
00015760 Kincaid, L. (1979) Metolachlor + Glyphosate + Linuron; Dual
Roundup 4E + Lorox SOW: AG-A No. 4763 I, II. (Unpublished stu
including letter dated May 23, 1978 from J.D. Riggleman to R
ert A. Kahrs, received Mar 16, 1979 under 100-583; prepared
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 SOW: AG-A No. 4886 I,II.
(Unpublished study including letter dated May 23, 1978 from
Riggleman to Robert A. Kahrs, received Mar 16, 1979 under
100-583; prepared in cooperation with E.I. du Pont de Nemour
Co., Inc. and ADC Laboratories, submitted by Ciba-Geigy Corp
Greensboro, N.C.: CDL:237821-C)
00015762 Searcy, V.; Herman, D. (1979) Metolachlor + Glyphosate +
Linuron; Dual 8E + Roundup 4E + Lorox SOW: AG-A No. 4893 1,1
(Unpublished study including letter dated May 23, 1978 from
Riggleman to Robert A. Kahrs, received Mar 16, 1979 under
100-583; prepared in cooperation with E.I. du Pont de Nemour
Co., Inc. and ADC Laboratories, submitted by Ciba-Geigy Corp
Greensboro, N.C.; CDL:237821-D)
00015763 Rose, W.; Worsham, D. (1979) Metolachlor + Glyphosate + Linu
Dual 8E + Roundup 4E + Lorox SOW: AG-A No. 4956 I,II A. (Unp
lished study including letter dated May 23, 1978 from J.D. R
gleman to Robert A. Kahrs, received Mar 16, 1979 under 100-5
prepared in cooperation with Rocky Mount Experiment Station,
Laboratories and E.I. du Pont de Nemours & Co., Inc., submit
by Ciba-Geigy Corp., Greensboro, N.C.; CDL:237821-E)
00015764 Kincaid, L. (1979) Metolachlor (Dual(R) 8E); Glyphosate (Rou
4E); Metribuzin (Sencor SOW): AG-A No. 4765 I,II. (Unpublish
study including letter dated May 23, 1978 from J.D. Rigglema
Robert A. Kahrs, received Mar 16, 1979 under 100-583; prepar
C-4
-------
in cooperation with ADC Laboratories and E.I. du Pont de Nem
& Co., Inc., submitted by Ciba-Geigy Corp., Greensboro, N.C.
CDL:237821-F)
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
Riggleman to Robert Kahrs, received Mar 16, 1979 under 100-5
prepared in cooperation with ADC Laboratories and E.I. du Po
de Nemours Co., Inc., submitted by Ciba-Geigy Corp., Greensb
N.C.; CDL:237821-G)
00015766 Searcy, S.; Herman, D. (1979) Metolachlor (Dual 8E); Glyphos
(Roundup 4E); Metribuzin (Sencor SOW): AG-A No. 4895 I,II.
(Unpublished study including letter dated May 23, 1978 from
Riggleman to Robert A. Kahrs, received Mar 16, 1979 under 10
583; prepared in cooperation with ADC Laboratories and E.I.
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); Glyphosa
(Roundup 4E); Metribuzin (Sencor SOW): AG-A No. 4958 I,II A.
(Unpublished study including letter dated May 23, 1978 from
Riggleman to Robert A. Kahrs, received Mar 16, 1979 under 10
583; prepared in cooperation with ADC Laboratories and E.I.
Pont de Nemours & Co., Inc., submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:237821-1)
00023336 Monsanto Company (1974) Residues of Glyphosate, Atrazine and
Simazine in or on Field Corn Grain, Sweet Corn and Corn Fora
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/
Atrazine plus Paraquat or Glyphosate—Corn: Summary of Resid
Data: Report No. ABR-79105. (Unpublished study received Dec
1979 under 100-583; prepared in cooperation with Chevron Che:
ical Co. and others, submitted by Ciba-Geigy Corp., Greensbo
N.C.; CDL:241647-A)
00024503 Monsanto Company (1974) Summary of Residue Data. (Unpublishe
study received Jan 16, 1978 under 524-285; CDL:232680-B)
C-5
-------
00027235 Monsanto Company (1979) Analytical Residue Method for
N-Phosphonomethylglycine (Glyphosate) and Aminomethylphospho
acid in Sugarcane, Bagasse, Raw Sugar and Molasses. (Unpubli
study received Dec 28, 1979 under 524-332; CDL:099157-B)
00028852 Monsanto Company (1976) Glyphosate Residues in Peanuts folio
Preemergent Treatment with Roundup Herbicide. (Unpublished s
received Feb 22, 1980 under 524-308; CDL:099306-A)
00028853 Monsanto Company (19??) Analytical Residue Method for
N-(Phosphonomethyl) glycine, Aminomethylphosphonic acid and
N-Nitroso-N(phosphonomethyl) glycine in Peanuts. (Unpublishe
study received Feb 22, 1980 under 524-308; CDL:099306-B)
00033954 Monsanto Company (1973) Summary and Conclusion: Residue Data
(Unpublished study received Dec 30, 1975 under 524-308; CDL:
224062-A)
00036222 Monsanto Company (1974) Analytical Residue Method for
N-Phosphonomethyl glycine and Aminomethylphosphonic acid in
and Water. Method B dated Nov 21, 1974. (Unpublished study
received Sep 25, 1975 under 6G1679; CDL:095356-A)
00036223 Monsanto Company (1974) Analytical Residue Method for
N-Phosphonomethyl glycine and Aminomethylphosphonic acid in
Forage and Grain. Method B dated Mar 1, 1974. (Unpublished s
received Sep 25, 1975 under 6G1679; CDL:095356-B)
00036229 Kramer, R.M.; Beasley, R.K.; Steinmetz, J.R.; et al. (1975)
Interim Report on CP 67573, Residue and Metabolism. Part 28:
Determination of Residues of Glyphosate and Its Metabolite i
Fish: Agricultural Research Report No. 378. (pp. 1-13 only;
unpublished study received Sep 25, 1975 under 6G1679; submit
by Monsanto Co., Washington, B.C.; CDL:095356-1)
00036231 Monsanto Company (1975) Analytical Residue Method for
N-Phosphonomethylglycine and Aminomethylphosphonic acid in F
Tissue. Method dated Sep 2, 1975. (Unpublished study receive
Sep 25, 1975 under 6G1679; CDL:095356-K)
00036328 Fink, R. (1975) Final Report: One Generation Reproduction
Study--Mallard Duck: Project No. 139-101. (Unpublished study
received Sep 26, 1975 under 6G1679; prepared by Truslow Farm
Inc., submitted by Monsanto Co., Washington, B.C.; CDL:09648
C-6
-------
00037687 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
Roundup, Lasso and Blades. (Unpublished study received Apr 1
1979 under 524-285; CDL:238167-B)
00037688 Monsanto Company (1979) Analytical Residue Method for
N-Phosphonomethyl Glycine, Aminomethylphosphonic acid and
N-Nitrosoglyphosate in Field Corn Forage, Fodder and Grain.
Method dated Jan 22, 1979. (Unpublished study received Apr 1
1979 under 524-285; CDL:238167-C)
00038770 Cowell, J.E.; Taylor, A.L.; Stranz, J.L.; et al. (1974) Fina
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 metho
entitled: Roundup and metabolite residue analytical method.
(Unpublished study received Oct 4, 1974 under 5fl560; submit
by Monsanto Co., Washington, B.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 Researc
Report No. 335. (Unpublished study received Oct 4, 1974 unde
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, Sma
Grains, Soil and Water: Agricultural Research Report No. 325
(Unpublished study received Jan 31, 1977 under 524-308;
submitted by Monsanto Co., Washington, B.C.; CDL:095787-B)
00038979 Cowell, J.E.; Taylor, A.L.; Stranz, J.L.; et al. (1974) Roun
and Metabolite Residue Analytical Method. (Unpublished study
ceived 1974 under 5G1561; submitted by Monsanto Co., Washing
B.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, B.C.; CDL:094958-B)
00039142 Beasley, R.K.; Kramer, R.M.; Carstarphen, B.A.; et al
1975
C-7
-------
Summary of Glyphosate (Roundup) Residue Studies in Citrus Fr
and Processed Fractions. (Unpublished study received Jan 26,
1976 under 6G1734; submitted by Monsanto Co., Washington, D.
CDL:095065-A)
00039377 Conkin, R.A.; Hannah, L.H.; Stewart, E.R. (1975) Residue Dat
for Roundup on Rice and in Fish. (Unpublished study received
26, 1975 under 6H5106; submitted by Monsanto Co., Washington
B.C.; CDL:094900-C)
00039381 Kramer, R.M.; Arras, D.D.; Beasley, R.K.; et al. (1975) Fina
Report on CP 67573 Residue and Metabolism: Agricultural Rese
Report No. 372. (Unpublished study received Sep 25, 1975 und
6G1679; prepared in cooperation with Washington State Univ.
others, submitted by Monsanto Co., Washington, B.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. (Un
lished study received Aug 13, 1975 under 5F1536; CDL:094866-
00040085 Monsanto Company (1975) Glyphosate Residues in Corn. (Unpub-
lished study received Aug 13, 1975 under 5F1536; CDL:094866-
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. (Unpublishe
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 stu
received on unknown date under SG1523; CDL:094036-C)
00044426 Monsanto Company (1973) Roundup Metabolite in Various Grains
C-8
-------
(Unpublished study received on unknown date under 5G1523, CD
094155-F)
00046362 Rodwell, D.E.; Tasker, E.J.; Blair, A.M.; et al. (1980)
Teratology Study in Rats: IRDC No. 401-054. (Unpublished st
including IRDC no. 999-021; received May 23, 1980 under 524-
prepared by International Research and Development Corp.,
submitted by Monsanto Co., Washington, B.C.; CDL:242516-A)
00046363 Rodwell, D.E.; Tasker, E.J.; Blair, M.; et al. (1980) Terato
Study in Rabbits: IRDC No. 401-056. (Unpublished study recei
May 23, 1980 under 524-308; prepared by International Resear
and Development Corp., submitted by Monsanto Co., Washington
B.C.; CDL:242516-B)
00048284 Monsanto Company (1973) Residue Data. (Compilation; unpublis
study received on unknown date under 524-EX-21; CDL:223373-E
00051980 Monsanto Company (1975) Residue Results. (Unpublished study
ceived Jun 3, 1976 under 524-308; CDL:096177-D)
00051982 Monsanto Company (1976) Analytical Residue Method for
N-Phosphonomethylglycine and Aminomethylphosphonic acid in G
Coffee Beans. Method dated May 1, 1976. (Unpublished study
received Jun 3, 1976 under 524-308; CDL:096177-F)
00051983 Malik, J.M.; Curtis, T.S.; Marvel, J.T. (1975) Final Report
CP67573, Residue and Metabolism; Part 24: The Metabolism of
67573 in Coffee Plants: Agricultural Research Report No. 344
(Unpublished study received Jun 3, 1976 under 524-308; submi
by Monsanto Co.xx Washington, B.C.; CDL:096177-1)
00053005 Beasley, R.K.; Steinmetz, J.R.; Taylor, A.L.; et al. (1977) .
lytical Residue Method for N-Phosphonomethyl glycine and Ami
methylphosphonic acid in Forage Legumes and Grasses: Report
MSL-0061. Method dated Jun 28, 1977. (Unpublished study rece
Sep 16, 1980 under 524-308; submitted by Monsanto Co.,
Washington, B.C.; CDL:099625-B)
00059050 Interregional Research Project Number 4 (1978) Summary of
Glyphosate Residues in Guava. (Unpublished study received No
19, 1980 under 1E2443; CDL:099739-A)
00060103 Baszis, S.R.; Cowell, J.; Lottman, M.; et al. (1980) Glyphos
Residues in Cotton following Topical Treatment with Roundup
C-9
-------
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-N
troso-N-(Phosphonomethyl)glycine in forages and grains. (Unp
lished study received Nov 12, 1980 under 524-EX-54; submitte
Monsanto Co., Washington, B.C.; CDL:099720-A)
00061555 Monsanto Company (1974) Residue Results. (Unpublished study
ceived on unknown date under 524-EX-24; CDL:095345-J)
00061559 Monsanto Company (19??) Analytical Residue Method for
N-Phosphonomethyl glycine (Glyphosate) and Aminomethylphosph
acid in Sugarcane, Sugarcane Leaves, Bagasse, Sugar and
Molasses, Irrigation Water and Soil. (Unpublished study rece
Mar 11, 1976 under 524-308; CDL:095141-E)
00063713 Monsanto Company (1979) Summary of Glyphosate Residues in
Papaya. (Unpublished study received Nov 20, 1980 under 524-3
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, Soi
and Water. Undated method 1. (Unpublished study received May
1977 under 524-308; CDL:229787-C)
00065752 Monsanto Company (1966?) Analytical Residue Method for
N-(Phosphonomethyl)-glycine, Aminomethylphosphonic Acid and
Nitroso-N(phosphonomethyl)-glycine in Forages, Grains and Wa
Undated method 2. (Unpublished study received May 12, 1977 u
524308; CDL:229787-D)
00065753 Frazier, H.W.; Rueppel, M.L. (1976) Crop Metabolism Studies
N(Phosphonomethyl)-glycine: N-Nitrosoglyphosate: Report No.
Interim rept. (Unpublished study received May 12, 1977 under
524-308; submitted by Monsanto Co., Washington, B.C.; CDL:
229787-E)
00067039 Birch, M.D. (1970) Toxicological Investigation of CP 67573-3
Project No. Y-70-90. (Unpublished study received Jan 30, 197
C-10
-------
under 524-308; prepared by Younger Laboratories, Inc., submi
by Monsanto Co., Washington, B.C.; CDL:008460-C)
00067425 Monsanto Company (1980) Residues of Glyphosate and Other
Herbicides in Wheat following Chemical Fallow Applications o
Roundup Tank Mix Combinations. Includes method dated Jul 1,
and undated methods entitled: 2,4-D in wheat forage, straw a
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 an
grain; Metribuzin and metabolites in wheat forage, straw and
grain. (Unpublished study, including published data, receive
Dec 29, 1980 under 524-308; CDL:243990-A; 2t3991)
00070893 LeBlanc, G.A.; Surprenant, B.C.; Sleight, B.H., III (1980) A
Toxicity of Roundup to the Water Flea (Daphnia magna): Repor
#BW-80-4-636; Monsanto Study No. BN-80-079. (Unpublished stu
including letter dated Feb 21, 1980 from R. Oleson to Robert
Foster, received Apr 2, 1981 under 524-308; prepared by EG &
Bionomics, submitted by Monsanto Co., Washington, B.C.;
CDL:244749-B)
00070895 LeBlanc, G.A.; Surprenant, B.C.; Sleight, B.H., III (1980) A
Toxicity of Roundup to Rainbow Trout (Salmo gairdneri): Repo
#BW-80-4-635; Monsanto Study No. BN-80-074. (Unpublished stu
received Apr 4, 1981 under 524-308; prepared by EG & G,
Bionomics, submitted by Monsanto Co., Washington, B.C.; CDL:
244749-D)
00070897 LeBlanc, G.A.; Surprenant, B.C.; Sleight, B.H., III (1980) A
Toxicity of Roundup to Bluegill (Lepomis macrochirus): Repor
#BW-80-4-634; Monsanto Study No. BN-80-075. (Unpublished stu
received Apr 2, 1981 under 524-308; prepared by EG & G,
Bionomics, submitted by Monsanto Co., Washington, B.C.; CDL:
244749-F)
00076491 Sleight, B.H., III (1973) Research Report Submitted to Monsa
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 Bionom
Inc., submitted by Monsanto Co., Washington, B.C.; CDL:12064
00076492 Fink, R. (1973) Final Report: Eight-day Dietary LC50--Bobwhi
Quail: Project No. 241-106. (Unpublished study received Nov
1973 under 524-308; prepared by Environmental Sciences Corp.
C-11
-------
submitted by Monsanto Co., Washington, B.C.; CDL:120640-D)
00076805 Baszis, S.R.; Serdy, F.S.; Dubelman, S. (1980) Glyphosate
Residues in Pasture Grasses, Legumes and Alfalfa following
Postemergent Spot Treatment with Roundup Herbicide: Report N
MSL-1140. Includes method dated Jul 1, 1979. (Unpublished st
received May 11, 1981 under 524-308; submitted by Monsanto C
Washington, B.C.; CDL:070083-A)
00077227 Branch, D.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; submi
by Monsanto Co., Washington, B.C.; CDL:070170-G)
00077228 Branch, O.K.; Stout, L.D.; Folk, R.M. (1981) Primary Eye Irr
tion of MON 2139 NF-80-W to Rabbits: EHL 800297. (Unpublishe
study received Jul 1, 1981 under 524-308; submitted by Monsa
Co., Washington, B.C.; CDL:070170-H)
00077229 Branch, O.K.; Stout, L.D.; Folk, R.M. (1981) Primary Skin Ir
tation of MON 2139 NF-80-W to Rabbits: EHL 800296. (Unpublis
study received Jul 1, 1981 under 524-308; submitted by Monsa
Co., Washington, B.C.; CDL:07D170-I)
00077230 Branch, O.K.; Stout, L.D.; Folk, R.M. (1981) Acute Oral Toxi
of MON 2139 NF-80-AA to Rats: EHL 800290. (Unpublished study
received Jul 1, 1981 under 524-308; submitted by Monsanto Co
Washington, B.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; submi
by Monsanto Co., Washington, B.C.; CDL:070170-K)
00077232 Branch, O.K.; Stout, L.D.; Folk, R.M. (1981) Primary Eye Irr
tion of MON 2139 NF-80-AA to Rabbits: EHL 800293. (Unpublish
study received Jul 1, 1981 under 524-308; submitted by Monsa
Co., Washington, B.C.; CDL:070170-L)
00077233 Branch, O.K.; Stout, L.D.; Folk, R.M. (1981) Primary Skin Ir
tation of MON 2139 NF-80-AA to Rabbits: EHL 800292. (Unpubli
study received Jul 1, 1981 under 524-308; submitted by Monsa
Co., Washington B.C.; CDL:070170-M)
00077234 Branch, O.K.; Stout, L.D.; Folk, R.M. (1981) Acute Oral Toxi
C-12
-------
of Mon 0139 to Rats: EHL 800257. ( Unpublished study receive
Jul 1, 1981 under 524-308; submitted by Monsanto Co., Wash-
ington, B.C.; CDL:070170-N)
00077235 Branch, D.K.; Stout, L.D.; Folk, R.M. (1981) Acute Dermal
Toxicity of MON 0139 to Rabbits: EHL 800258. (Unpublished st
received Jul 1, 1981 under 524-308; submitted by Monsanto Co
Washington, B.C.; CDL:070170-0)
00077236 Branch, D.K.; Stout, L.D.; Folk, R.M. (1981) Primary Eye Irr
tion of MON 0139 to Rabbits: EHL 800260. (Unpublished study
received Jul 1, 1981 under 524-308; submitted by Monsanto Co
Washington, B.C.; CDL:070170-P)
00077237 Branch, D.K.; Stout, L.D.; Folk, R.M. (1981) Primary Skin Ir
tation of MON 0139 to Rabbits: EHL 800259. (Unpublished stud
received Jul 1, 1981 under 524-308; submitted by Monsanto Co
Washington, B.C.; CDL:070170-Q)
00077238 Dubelman, S.; Steinmetz, J.R. (1981) Glyphosate Residues in
Water following Application of Roundup Herbicide to Flowing
ies of Water: MSL-1486. Final rept. Includes method dated Se
1980. unpublished study received Jul 1, 1981 under 524-308;
prepared in cooperation with Analytical Biochemistry Labs,
submitted by Monsanto Co., Washington B.C.; CDL:070170-R)
00077301 Monsanto Company (1975) Residue Results. (Compilation;
unpublished study, including published data, received Mar 11
1976 under 524-308; CDL:095141-A)
00078619 Shirasu, Y.; Moriya, M.; Ohta, T. (1978) Microbial Mutagenic
Testing on CP67573 (Glyphosate). (Unpublished study received
25, 1979 under 524-308; prepared by Institute of Environment
Toxicology, Japan, submitted by Monsanto Co., Washington, D.
CDL:238233-A)
00078620 Kier, L.D.; Flowers, L.J.; Hannah, L.H. (1978) Final Report
Salmonella Mutagenicity Assay of Glyphosate: Test No. LF-78-
(Unpublished study received Apr 25, 1979 under 524-308; sub-
mitted by Monsanto Co., Washington, B.C.; CDL:238233-B)
00078655 Thompson, C.M.; Griffen, J.; Boudreau, P. (1980) Acute Toxic
of MON 2139 NF-80W (AB-80-363) to Rainbow Trout (Salmo gaird
ri): Static Acute Bioassay Report #26316. (Unpublished study
received Jul 1, 1981 under 524-308; prepared by Analytical B
C-13
-------
Chemistry Laboratories, Inc., submitted by Monsanto Co.,
Washington, B.C.; CDL:070171-B)
00078656 Thompson, C.M.; Griffen, J.; (1980) Acute Toxicity of MON 21
NF80W (AB-80-364) to Bluegill Sunfish (Lepomis macrochirus):
Static Acute Bioassay Report #26315. (Unpublished study rece
Jul 1, 1981 under 524-308; prepared by Analytical Bio Chemis
Laboratories, Inc., submitted by Monsanto Co., Washington, D
CDL:070171-C)
00078657 Forbis, A.D.; Boudreau, P. (1980) Acute Toxicity of MON
2139-NF-80W (AB-80-365) to Daphnia magna: Static Acute Bioas
Report #26317. (Unpublished study received Jul 1, 1981 under
524-308; prepared by Analytical Bio Chemistry Laboratories,
Inc., submitted by Monsanto Co., Washington, B.C.; CDL:07017
00078658 Thompson, C.M.; Griffen, J.; Forbis, A.D. (1980) Acute Toxic
of MON 2139 NF-80-AA (AB-80-367) to Rainbow Trout (Salmo gai
neri): Static Acute Bioassay Report #26319. (Unpublished stu
received Jul 1, 1981 under 524-308; prepared by Analytical B
Chemistry Laboratories, Inc., submitted by Monsanto Co.,
Washington, B.C.; CDL:070171-E)
00078659 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. (Unpublis
study received Jul 1, 1981 under 524-308; prepared by Analyt
Bio Chemistry Laboratories, Inc., submitted by Monsanto Co.,
Washington, B.C.; CDL:070171-F)
00078660 Boudreau, P.; Forbis, A.D. (1980) The Acute Toxicity of MON
NF-80-AA (AB-80-369) to Daphnia magna: Static Acute Bioassay
Report #26320. (Unpublished study received Jul 1, 1981 under
524-308; prepared by Analytical Bio Chemistry Laboratories,
Inc., submitted by Monsanto Co., Washington, B.C.; CDL:07017
00078661 Thompson, C.M.; Griffen, J. (1981) Acute Toxicity of MON 013
(Lot LURT 12011) (AB-81-072) to Rainbow Trout (Salmo gairdne
Static Acute Bioassay Report #27202. (Unpublished study rece
Jul 1, 1981 under 524-308; prepared by Analytical Bio Chemis
Laboratories, Inc., submitted by Monsanto Co., Washington, D
CDL:070171-H)
00078662 Griffen, J.; Thompson, C.M. (1981) Acute Toxicity of MON 013
(Lot LURT 12011) (AB-81-073) to Bluegill Sunfish (Lepomis ma
C-14
-------
chirus): Static Acute Bioassay Report #27201. (Unpublished s
received Jul 1, 1981 under 524-308; prepared by Analytical B
Chemistry Laboratories, Inc., submitted by Monsanto Co.,
Washington, B.C.; CDL:070171-1)
00078663 Forbis, A.D.; Boudreau, P. (1981) Acute Toxicity of MON 0139
(Lot LURT 12011) (AB-81-074) to Daphnia magna: Static Acute
assay Report #27203. ( Unpublished study received Jul 1, 198
under 524-308; prepared by Analytical Bio Chemistry Laborato
ries, Inc., submitted by Monsanto Co., Washington, B.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 B
Chemistry Laboratories, Inc., submitted by Monsanto Co.,
Washington, B.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. (Unpublis
study received Jul 1, 1981 under 524-308; prepared by Analyt
Bio Chemistry Laboratories, Inc., submitted by Monsanto Co.,
Washington, B.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, 1
under 524-308; prepared by Analytical Bio Chemistry
Laboratories, Inc., submitted by Monsanto Co., Washington, D
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, 198
under 524- 308; CDL:245567-A)
00078824 Monsanto Company (1980) Glyphosate Residues in Brewed and
Instant Tea following Postemergent Directed Treatment in Tea
Plantations with Roundup Herbicide: MSL-1582. (Unpublished s
received Jun 17, 1981 under 524-308; CDL:245567-B)
00081674 Schroeder, R.E.; Hogan, G.K. (1981) A Three-Generation
Reproduction Study with Glyphosate in Rats: Project No. 77-2
C-15
-------
(Unpublished study received Sep 22, 1981 under 524-308; prep
by Bio/dynamics, Inc., submitted by Monsanto Co., Washington
B.C.; CDL:245909-A)
00093879 Lankas, G.R.; Hogan, G.K. (1981) A Lifetime Feeding Study of
Glyphosate (Roundup Technical) in Rats: Project No. 772062.
(Unpublished study received Jan 20, 1982 under 524-308; prep
by Bio/dynamics, Inc., submitted by Monsanto Co., Washington
B.C.; CDL:246617-A; 246618; 246619; 246620; 246621)
00094971 Grabiak, M.C.; Malik, J.M.; Purdum, xx.R. (1981) A
Reinvestigation of the Static Exposure of Channel Catfish to
14C-Labeled Glyphosate, N-(Phosphonomethyl) Glycine: Report
MSL-2056. (Unpublished study, including final bioconcentrati
report no. 27497, received Mar 2, 1982 under 524-308; submit
by Monsanto Co., Washington, B.C.; CBL:246876-A)
00098460 Johnson, B.E.; Nair, K.P.C.; Riley, J.H.; et al. (1982) 21-d
Bermal Toxicity Study in Rabbits: 401-168; Monsanto No. IR-8
195. (Unpublished study received Apr 12, 1982 under 524-308;
prepared by International Research and Bevelopment Corp., su
mitted by Monsanto Co., Washington, B.C.; CBL:247228-A)
00105995 Street, R. (1982) Letter sent to R. Taylor dated Jul 6, 1982
Roundup herbicide: Addendum to pathology report for a three-
generation reproduction study in rats with glyphosate. (Unpu
lished study received Jul 7, 1982 under 524-308; submitted b
Monsanto Co., Washington, BC; CBL:247793-A)
00108097 Rueppel, M.; Suba, L.; Conoyer, M.; et al. (1973) Final Repo
on CP 67573, Residue and Metabolism: Part 10: The Metabolism
CP 67573 in Soybeans, Cotton, Wheat, and Corn: Agricultural
Research Report No. 304. (Unpublished study received Nov 12,
1973 under 4G1444; submitted by Monsanto Commercial Products
Co., St. Louis, MO; CBL:093849-B)
00108098 Colvin, L.; Miller, J.; Marvel J. (1973) Final Report on CP
67573 Residue and Metabolism: Part 8: The Gross Metabolism o
... (CP 67573-14C) in the Laboratory Rat following a Single
Bose: Agricultural Research Report No. 297. (Unpublished stu
received Nov 12, 1973 under 4G1444; submitted by Monsanto
Commercial Products Co., St. Louis, MO; CBL:093849-C)
00108099 Colvin, L.; Miller, J.; Marvel, J. (1973) Final Report on CP
67573 Residue and Metabolism: Part 9: The Gross Bistribution
C-16
-------
... CP 67573-14C in the Rabbit: Agricultural Research Report
298. (Unpublished study received Nov 12, 1973 under 4G1444;
mitted by Monsanto Commercial Products Co., St. Louis, MO; C
093849-D)
00108100 Colvin, L.; Moran, S.; Miller, J.; et al. (1973) Final Repor
CP 67573 Residue and Metabolism: Part 11: The Metabolism of
CP 50435-14C in the Laboratory Rat: Agricultural Research Re
No. 303. (Unpublished study received Nov 12, 1973 under 4G14
submitted by Monsanto Commercial Products Co., St. Louis, MO
CDL:093849-E)
00108101 Moran, S.; Colvin, L.; Rueppel, M.; et al. (1973) Final Repo
on CP 67573 Residue and Metabolism: Part 12: The Isolation a
Identification of the Metabolites of CP 67573-14C Excreted b
the Laboratory Rat: Agricultural Research Report No. 306. (U
published study received Nov 12, 1973 under 4G1444; submitte
Monsanto Commercial Products Co., St. Louis, MO; CDL: 093849
00108107 Fink, R. (1973) Final Report: Eight-day Dietary LC50--Mallar
Ducks: Technical CP67573: Project No. 241-107. (Unpublished
study received Jul 12, 1974 under 5F1536; prepared by Enviro
mental Sciences Corp., submitted by Monsanto Co., Washington
DC; CDL:094171-1)
00108110 Bentley, R. (1973) Acute Toxicity of Roundup (Technical) to
Atlantic Oyster (Crassostrea virginica). (Unpublished study
received Jul 12, 1974 under 5F1536; prepared by Bionomics, I
submitted by Monsanto Co., Washington, DC; CDL:094171-L)
00108111 Bentley, R. (1973) Acute Toxicity of Roundup (Technical) to
Grass Shrimp (Palaemonetas vulgaris) and Fiddler Crab (Uca
pagilator). (Unpublished study received Jul 12, 1974 under
5F1536; prepared by Bionomics, Inc., submitted by Monsanto,
Washington, DC; CDL:094171-M)
00108112 Merrill, L. (1973) Acute Toxicity of Roundup to Bluegill
(Lepomis macrochirus). (Unpublished study received Jul 12,
under 5F536; prepared by Bionomics, Inc., submitted by Monsa
Co., Washington, DC; CDL: 094171-N)
00108115 Lauer, R.; Cowell, J.; Stranz, J.; et al. (1974) Final Repor
CP 67573, Residue and Metabolism: Part 18: Determination of
idues in Meat, Milk and Eggs: Agricultural Research Report N
326. (Unpublished study-received Jul 12, 1974 under 5F1536;
C-17
-------
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 N
309. (Unpublished study received Jul 12, 1974 under 5F1536;
submitted by Monsanto Co., St. Louis, MO; CDL:094180-C)
00108129 Monsanto Co. (1976) Residue Studies and Methods of Analysis
Use of Glyphosate in Pome Fruit Orchards. (Compilation;
unpublished study received Sep 7, 1976 under 524-308;
CDL:095269-C)
00108132 Cowell, J.; Lottman, C.; Cable, M.; et al. (1976) Determinat
of Roundup Herbicide Residues in Raisins: Report No. 440. Fi
rept. (Unpublished study received Jan 11, 1977 under 524-308
submitted by Monsanto Co., Washington, DC; CDL:095703-A)
00108133 Monsanto Co. (1976) Residue Studies in Green and Dry Alfalfa
Metabolism Studies in Pasture Crops: Glyphosate. (Compilatio
unpublished study received Jan 11, 1977 under 524-308;
CDL:095704-A)
00108140 Monsanto Co. (1975) Glyphosate Residue and Metabolism Studie
Sugarcane and Soils. (Compilation; unpublished study receive
Jul 1, 1976 under 6G1826; CDL:095972-B)
00108144 Monsanto Co. (1977) Study: Residue and Metabolism Analyses o
Roundup on Specific Foodstuffs. (Compilation; unpublished st
received Feb 14, 1978 under 524-EX-44; CDL:096821-A)
00108147 Monsanto Co. (1977) Residue and Metabolism: Roundup on Forag
Grasses, Legumes and Pasture Crops. (Unpublished study recei
May 9, 1978 under 524-308; CDL:097094-B)
00108149 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 PI
Sciences, submitted by Monsanto Co., Washington, DC;
CDL:096631-A)
00108151 Monsanto Co. (1976) Residue, Uptake and Metabolism Studies:
C-18
-------
Roundup. (Compilation; unpublished study received Dec 22, 19
under 524-EX-43; CDL:096684-A)
00108153 Monsanto Agricultural Products Co. (1975) Residues: Glyphosa
on Soybeans & Cotton. (Compilation; unpublished study receiv
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
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 t
Fathead Minnow (Pimephales promelas, Rafinesque). (Unpublish
study received Dec 27, 1978 under 524-308; submitted by Mons
Co., Washington, DC; CDL:097759-B)
00108172 McAllister, W.; Forbis, A. (1978) Acute Toxicity of Technica
Glyphosate (AB-78-201) to Daphnia magna. (Unpublished study
ceived Dec 27, 1978 under 524-308; prepared by Analytical Bi
Chemistry Laboratories, Inc., submitted by Monsanto Co., Was
ngton, DC; CDL:097759-C)
00108173 Monsanto Co. (1978) Residue Studies for Use of Roundup Herbi
in Aquatic Situations. (Compilation; unpublished study recei
Dec 27, 1978 under 524-308; CDL:097760-A; 097761; 097762)
00108174 Monsanto Co. (1975) Efficacy of Roundup on Corn and Other Gr
(Compilation; unpublished study received Dec 3, 1975 under
5F1536; CDL:097859-A)
00108175 Monsanto Co. (1979) Residue Studies--Bananas; Olives: Roundu
(Compilation; unpublished study received Jun 20, 1979 under
524-308; CDL:098332-A)
00108176 Monsanto Co. (1975) Residue Studies and Methods of Analysis
Pre-emergent Use of Glyphosate in Cotton. (Compilation; un-
published study received May 20, 1976 under 6F1798; CDL:
098511-A)
00108186 Monsanto Co. (1976) Residue Studies and Methods of Analysis
C-19
-------
Use of Glyphosate in Pome Fruit Orchards. (Compilation; unpu
lished study received Sep 7, 1976 under 524-308; CDL:228995-
00108192 Brightwell, B.; Malik, J. (1978) Solubility, Volatility,
Adsorption and Partition Coefficients, Leaching and Aquatic
Metabolism of MON 0573 and MON 0101: Report No. MSL-0207. Fi
rept. (Unpublished study received Jun-12, 1978 under 524-308
submitted by Monsanto Co., Washington, DC; CDL:234108-A)
00108200 Grapenthien, N.; Jenkins, D.; (1973) Report to ...: Milk and
Tissue Residue Study with ... CP 67573 in the Cow: IBT No.
632-03894. (Unpublished study received Jun 21, 1978 under
524-308; prepared by Industrial Bio-Test Laboratories, Inc.,
submitted by Monsanto Co., Washington, DC; CDL:234152-A)
00108203 Cowell, J.; Kramer, R.; Lottman, C.; et al. (1978) Residues
Crops following Spot Treatments with Roundup Herbicide: Repo
No. MSL-0282. Final rept. (Unpublished study received Jul 11
1978 under 524-308; submitted by Monsanto Co., Washington, D
CDL:234319-B)
00108204 Fink, R.; Beavers, J.; Brown, R. (1978) Final Report: Acute
LD50--Bobwhite Quail: Technical Glyphosate: Project No. 1391
(Unpublished study received Jul 14, 1978 under 524-308; prep
by Wildlife International, Ltd. and Washington College,
submitted by Monsanto Co., Washington, DC; CDL:234395-A)
00108205 McAllister, W.; Forbis, A. (1978) Acute Toxicity of Technica
Glyphosate to Bluegill Sunfish (Lepomis macrochirus): Static
Acute Bioassay Report. (Unpublished study received Jul 14, 1
under 524-308; prepared by Analytical Bio Chemistry Laborato
ries, Inc., submitted by Monsanto Co., Washington, DC; CDL:
234395-B)
00108207 Fink, R.; Beavers, J. (1978) Final Report: One-generation
Reproduction study--Bobwhite Quail: Glyphosate Technical:
Project No. 139-141. (Unpublished study received Nov 13, 197
under 524-308; prepared by Wildlife International, Ltd.,
submitted by Monsanto Co., Washington, DC; CDL:235924-B)
00108231 Conkin, R.; Serdy, F.; Street, R. (1979) A Short Residue Met
for Glyphosate, Active Ingredient in Roundup Herbicide: MSLO
(Unpublished study received Jul 30, 1979 under 524-308;
submitted by Monsanto Co., Washington, DC; CDL:238888-A)
C-20
-------
00109271 Monsanto Co. (19??) Crop Residues and Tolerances. (Unpublish
study received Apr 9, 1982 under KS 82/1 for Monsanto; CDL:
247348-B)
00111945 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
Fruit following Postemergent Directed Treatments with Roundu
Herbicide: Report No. MSL-0454. Final rept. (Unpublished stu
received Nov 20, 1978 under 524-EX-47; prepared in cooperati
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: Proj
No. 139-143. (Unpublished study received Nov 13, 1978 under
524-308; prepared by Wildlife International Ltd., submitted
Monsanto Co., Washington, DC; CDL:235924-A)
00122715 Steinmetz, J.; Cowell, J. (1982) Glyphosate Residues in Whea
Grain following Ropewick Wiper Treatment with Roundup Herbic
MSL-2569. (Unpublished study received Dec 17, 1982 under 524
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 #28746.
(Unpublished study received Dec 27, 1982 under 524-308; prep
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-ho
Acute Toxicity of Roundup (AB-82-035) to Gammarus pseudolim-
naeus: Dynamic Acute Bioassay Report #28747. (Unpublished st
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) Chro
Toxicity of Glyphosate (AB-82-036) to Daphnia magna under Fl
through Test Conditions: Chronic Toxicity Final Report ABC
#28742. (Unpublished study received Dec 27, 1982 under 524-3
prepared by Analytical Bio-Chemistry Laboratories, Inc., sub
C-21
-------
mitted 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, 1
under 524-308; prepared by Bio/dynamics, Inc., submitted by '.
santo Co., Washington, DC; CDL:251007-A; 251008; 251009; 251
251011; 251012; 251013; 251014)
00132681 Li, A.; Kier, L.; Folk, R. (1983) CHO/HGPRT Gene Mutation As
with Glyphosate: EHL Study No. ML-83-155. Final rept. (Un-
published study received Nov 15, 1983 under 524-308; submitt
by Monsanto Co., Washington, DC; CDL:251737-B)
00132683 Li, A.; Kier, L.; Folk, R. (1983) In vivo Bone Marrow
Cytogenetics Study of Glyphosate in Sprague-Dawley Rats: Stu
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
Plasma and Bone Marrow Levels of Glyphosate following Intrap
toneal Administration in the Rat: Study No. 830109. (Unpubli
study received Nov 15, 1983 under 524-308; submitted by Mons
Co., Washington, DC; CDL:251737-F)
00132686 Williams, G.; Tong, C.; Dirks, R.; et al. (1983) The Hepatoc
Primary Culture/DNA Repair Assay on Compound JJN-1020 Using
Hepatocytes in Culture: NDItln vitro Facility Experimental N
083183A; Sponsor Order No. AH-83-181. (Unpublished study
received Nov 15, 1983 under 524-308; prepared by Naylor Dana
Institute for Disease Prevention, submitted by Monsanto Co.,
Washington, DC; CDL:251737-G)
GS0178-003 Suba, L. (1976) Metabolism of CP67573 in Representative
Vegetables and Rotation Crops: Final Report No. 406.
Unpublished study prepared by Monsanto Agricultural
Research Dept. 57 p.
GS0178-004 Brightwell, B. (1978) Bioaccumulation and Metabolism
of Glyphosate in Channel Catfish (Ictalurus punctatus: Final Repo
No. MSL-0381. Unpublished study prepared by Monsanto Agricultural
Research Dept. 34 p.
GS0178-014 Lauer, R.; Cowell, J.; Briggs, L.; et al. (1974) Roundup
C-22
-------
and Metabolite Residue Method Development for Animal Tissues
Products: Appendix C. Unpublished study prepared by Monsanto
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.
p.
GS0178-019 Storherr, R. (1980) Letter sent-to E. Zager dated Sept.
19, 1980: Glyphosate HPLC Method trial on tomatoes and
cottonseed. 3 p.
GS0178-020 Storherr, R. (1981) Letter sent to M. Nelson dated Jan
19, 1981: Method trial on PP #OF2329, glyphosate in or on
peanuts, by an HPLC procedure. 3 p.
GS0178-022 Zee, K. (1975) Memorandum to J. Cummings dated Nov 1,
1975: PP #5F1536. Method tryout for glyphosate on soybeans.
GS0178-023 Zee, K. (1977) Memorandum to J. Cummings dated Feb 9,
1977: PP #6F1733 and 6F1758. Method tryout for glyphosate in
beef liver. 2 p.
GS0178-025 Folmar, L.; Sanders, H.; Julin, A. (1979) Toxicity of the
herbicide glyphosate and several of its formulations to fish
aquatic invertebrates. Arch. Environm. Contam. Toxicol .
8:269-278.
GS0178-028 Monsanto Co. (1976) Information to Support
Establishment of a Food Additive Tolerance for Glyphosate in
Palm Oil: Special Report No. 424. Vol 1 of 1, Sections A-J.
Unpublished study. 41 P.
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)
Lethal Dietary Toxicities of Environmental Pollutants to Bi
U.S.F.W.S. Special Scientific .Report—Wildlife No. 191.
Hoerger and Kenaga (1972) Pesticide Residues on Plants.
C-23
-------
Correlation of Representative Data as a Basis for Estimation
their Magnitude in the Environment. Environmental Quality.
Academic Press, N.Y.1:9-28.
Kenaga (1973) Factors to be considered in the Evaluation of
Pesticides to Birds in their Environment. Environmental
Quality, Academic Press, N.Y.IJ.: 166-181.
Leonard, W.H. and Martin, J.H. (1963) Cereal Crops. Part V.
Rice, Sorghum, and Millets, page 635.
USDA, The biologic and economic assessment of 2,4,5-T,
Cooperative Impact Assessment Technical Bulletin Number 1671
Wauchope (1978) The Pesticide Content of Surface Water Draining
from Agricultural Fields - A Review, J. Environ. Qual., Vol
7.7, No. 4.
00067039 Birch, M.D. (1970) Toxicological Investigation of CP 67573-3
Project No. Y-70-90. (Unpublished study received Jan 30, 19
under 524-308; prepared by Younger Laboratories, Inc., submi
by Monsanto Co., Washington, B.C.; CDL:008460-C)
40159301 Bohn, J. (1987) An Evaluation of the Preemergence Herbicidal
Activity of CP-70139: Lab Project ID: 056337. Unpublished
study prepared by Monsanto Agricultural Co. 25 p.
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.
Unpublished study prepared by Malcolm Pirnie, Inc. 23 p.
40236903 Hughes, J. (1987) The Toxicity of Glyphosate Technical to
Skeletonema costatum: Lab Project ID: 1092-02-1100-3.
Unpublished study prepared by Malcolm Pirnie, Inc. 24 p.
40236904 Hughes, J. (1987) The Toxicity of Glyphosate Technical to
Anabaena flosaquae: Lab Project ID: 1092-02-1100-4.
Unpublished study prepared by Malcolm Pirnie, Inc. 23 p.
40236905 Hughes, J. (1987) The Toxicity of Glyphosate Technical to Le:
gibba: Lab Project ID: 1092-02-1100-5. Unpublished study
C-24
-------
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 prepare
Bio/dynamics, Inc. 20 p.
41400604 Blaszcak, D. (1988) Primary Dermal Irritation Study in Rabbi
for Glyphosate Technical (Wetcake): Lab Project Number: 4887
Monsanto Reference No. BD-88-114. Unpublished study prepare
Bio/dynamics, Inc. 17 p.
ACCSN: 252142
A
B
C
D
MRID:
MRID:
MRID:
MRID:
00137137
00137138
00137139
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-
007. (Unpublished study received Jan 5, 1984 under 524-308;
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/dynami
Project No. 4235-82; Monsanto Reference No. BD-83-008.
(Unpublished study received Jan 5, 1984 under 524-308; prepa
by Bio/dynamics, Inc., submitted by Monsanto Co., Washington
DC; CDL: 252142-B)
00137139 Maibach, H. (1982) [Toxicity: 14C-glyphosate in Monkeys].
(Unpublished study received Jan 5, 1984 under 524-308; prepa
by Univ. of California--San Fransisco, School of Medicine,
submitted by Monsanto Co., Washington, DC; CDL:252142-C)
00137140 Franz, T. (1983) Evaluation of the Percutaneous Absorption o
Roundup Formulations in Man Using an in vitro Technique:
Monsanto Study No. UW-81-346. Final rept. (Unpublished stu
received Jan 5, 1984 under 524-308; prepared by Univ. of
Washington, School of Medicine, submitted by Monsanto Co.,
Washington, DC; CDL:252142-D)
40405401 Hirsch, R.; Augustin, D. (1987) Nitrosamine Analyses of Roun
Herbicide, rodeo Herbicide, MON 0139 and Polado Technical:
C-25
-------
Laboratory Project ID R. D. No. 835. Unpublished study prep
by Monsanto Agricultural Company. 212 p.
41400601 Blaszcak, D. (1988) Acute Oral Toxicity Study in Rats for
Glyphosate Technical (Wetcake) ...: Lab Project Number: 4885
Monsanto Reference No. BD-88-114. Unpublished study prepare
Bio/dynamics, Inc. 18 p.
41400602 Blaszcak, D. (1988) Acute Dermal Toxicity Study in Rabbits f
Glyphosate Technical (Wetcake): Lab Project Number: 4886-88:
Monsanto Reference No. BD-88-114. Unpublished study prepare
Bio/dynamics, Inc. 17 p.
41573601 Herre, B.; Korndorfer, C.; Barclay, J. (1990) Product Chemis
Data to Support the Registration of the 62% Solution of the
Isopropylamine Salt of Glyphosate (MON-0139): Storage Stabi
Study: Lab Project Number: MSL-6199: 1006. Unpublished s
prepared by Monsanto Agricultural Co. 12 p.
40559401 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.
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; prep
by Bio/dynamics, Inc., submitted by Monsanto Co., Washington
B.C.; CDL:246617-A; 246618; 246619; 246620; 246621)
00036803 Street, R.W.; Conkin, R.A.; Edwards, G.A.; et al. (1980) A
Three-Month Feeding Study of Glyphosate in Mice: Special Rep
# MSL-1154. (Unpublished study received Jul 2, 1980 under 5
308; submitted by Monsanto Co., Washington, B.C.; CDL:242799
00098460 Johnson, D.E.; Nair, K.P.C.; Riley, J.H.; et al. (1982) 21-d
Dermal Toxicity Study in Rabbits: 401-168; Monsanto No. IR-8
195. (Unpublished study received Apr 12, 1982 under 524-308
prepared by International Research and Development Corp.,
submitted by Monsanto Co., Washington, B.C.; CDL:247228-A)
00153374 Reyna, M. (1985) Twelve Month Study of Glyphosate Administer
by Gelatin Capsule to Beagle Dogs: Project No. ML-83-137: St
No. 830116. Unpublished study prepared by Monsanto Company
Environmental Health. 317 p.
C-26
-------
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; prep
by Bio/dynamics, Inc., submitted by Monsanto Co., Washington
B.C.; CDL:246617-A; 246618; 246619; 246620; 246621)
41643801 Stout, L.; 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 Administer
by Gelatin Capsule to Beagle Dogs: Project No. ML-83-137: St
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., submitte
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, 198
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 st
including IRDC no. 999-021; received May 23, 1980 under 524-
prepared by International Research and Development Corp.,
submitted by Monsanto Co., Washington, B.C.; CDL:242516-A)
00046363 Rodwell, D.E.; Tasker, E.J.; Blair, M.; et al. (1980) Terato
Study in Rabbits: IRDC No. 401-056. (Unpublished study rece
May 23, 1980 under 524-308; prepared by International Resear
and Development Corp., submitted by Monsanto Co., Washington
B.C.; CDL:242516-B) 00105995 Street, R. (1982) Letter sent t
Taylor dated Jul 6, 1982: Roundup herbicide: Addendum to
pathology report for a three-generation reproduction study i
rats with glyphosate. (Unpublished study received Jul 7, 19
under 524-308; submitted by Monsanto Co., Washington, DC;
CDL:247793-A)
C-27
-------
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; submi
by Monsanto Co., Washington, DC; CDL:247793-A)
41621501 Reyna, M. (1990) Two Generation Reproduction Feeding Study w
Glysophate in Sprague-Dawley Rats: Lab Project No: MSL-10387
Unpublished study prepared by Monsanto Agricultural Co. 115
00078620 Kier, L.D.; Flowers, L.J.; Hannah, L.H. (1978) Final Report
Salmonella Mutagenicity Assay of Glyphosate: Test No. LF-78-
(Unpublished study received Apr 25, 1979 under 524-308;
submitted by Monsanto Co., Washington, B.C.; CDL:238233-B)
00132681 Li, A.; Kier, L.; Folk, R. (1983) CHO/HGPRT Gene Mutation As
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)
00132683 Li, A.; Kier, L.; Folk, R. (1983) In vivo Bone Marrow
Cytogenetics Study of Glyphosate in Sprague-Dawley Rats: Stu
No. 830083. (Unpublished study received Nov 15, 1983 under
308; submitted by Monsanto Co., Washington, DC; CDL:251737-D
00078619 Shirasu, Y.; Moriya, M.; Ohta, T. (1978) Microbial Mutagenic
Testing on CP67573 (Glyphosate). (Unpublished study receive
April 25, 1979 under 524-308; prepared by Institute of
Environmental Toxicology, Japan, submitted by Monsanto Co.,
Washington, B.C.; CDL:238233-A)
40767101 Ridley, W.; Mirly, K. (1988) The Metabolism of Glyphosate in
Sprague Dawley Rats--Part I. Excretion and Tissue Distributi
of Glyphosate and Its Metablites following Intravenous and 0
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.
00132685 Ridley, W., Dietrich, M.; Folk, R.; et al. (1983) A Study of
C-28
-------
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)
Study No.: UW-81-346; Date: 8/30/83; No MRID or Accession No.)
"Pesticides Contaminated with N-nitroso Compounds, proposed policy 45
42854 (June 25, 1980)"
00152596 Thompson, C.; McAllister, W. (1983) Acute Toxicity of Liqua
to Rainbow Trout (Salmo gairdneri): Report #30409. Unpubli
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. Unpubli
study prepared by Analytical Bio-Chemistry Laboratories, Inc
46 p.
00152601 Thompson, C.; McAllister, W. (1983) Acute Toxicity of Passag
Rainbow Trout (Salmo gairdneri): Report No. 30412. Unpubli
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 Bioa
Report No. 30415. Unpublished Monsanto Study No. AB-83-120
prepared by Analytical Bio-Chemistry Laboratories, Inc. 46
00152597 Burgess, D.; Forbis, A. (1983) Acute Toxicity of Liqua-Wet t
Daphnia magna: Report No. 30410. Unpublished study prepare
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 prepare
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 prepare
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
30416. Unpublished Monsanto Study No. AB-83-122 prepared by
C-29
-------
Analytical Bio-Chemistry Laboratories, Inc. 36 p.
41335101 Shepler, K. ; McGovern, P. (1989) Photodegradation of Carbon-
Glyphosate in/on Soil by Natural Sunlight: Lab Project Numb
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:
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 Suppo
the Registration of MON-8783 (FallowMaster): Storage Stabil
Study: Laboratory Project ID MSL-6537, R. D. No. 819.
Unpublished study prepared by Monsanto Agricultural Company.
p.
00162912 Ruecker, F. (1986) Addendum to One-year Toxicology Study in
with Glyphosate: Special Report MSL-5927. Unpublished adde
prepared by Monsanto Agricultural Co. 6 p.
00046364 Rodwell, D. E.; Wrenn, J. M.; Blair, A. M.; et al. (1980)
Dominant Lethal Study in Mice: IRDC No. 401-064. (Unpublis
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 Glyphosa
and MON-7200/15100: Project No. MSL-7642; R.D. No. 924.
Unpublished study prepared by Monsanto Agricultural Co. 59
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)
C-30
-------
00053002 Monsanto Company (1980) Summary: Glyphosate. Includes undat
method entitled: Analysis of Glyphosate in cranberries; unda
method entitled: Glyphosate and metabolite; and undated meth
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, 0. (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;
093861-A)
00136339 Thompson, C.; Mcallister, W. (1978) Acute Toxicity of Techni
Glyphosate (AB-78-165) to Rainbow Trout (Salmo gairdneri).
(Unpublished study received Dec 5, 1978 under 524-308; prepa
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 sev
0,0-Dialkyl alpha-acyloxyethyl phosphonates. Agricultural a
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 Blue
Sunfish (Lepomis macrochirus): Static Bioassay Report No. 30
Unpublished Monsanto Study No. AB-83-121 prepared by Analyt
Bio-Chemistry Laboratories, Inc. 46 p.
00152903 Cohle, P.; McAllister, W. (1983) Acute Toxicity of Passage t
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 adjuv
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.
(Unpublished study received on unknown date under 4G1444;
prepared by Huntingdon Research Centre, submitted by Monsant
Co., Washington, B.C.; CDL:093848-R)
C-31
-------
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 Monsan
Agricultural Co. 42 p.
41689101 Castle, S. ; Ruzo, L. ; Kathryn, S. (1990) Degradation Study:
Photodegradation of Carbon 14 Glyphosate in a Buffered Aqueo
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
carbon 14 Glyphosate in Sandy Loam and Silt Loam Soils with
Biometer Flask: Supplement to MRID 41742901: Unpublished st
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 41723
Unpublished study prepared by Monsanto Agricultural Comp. 1
42372503 Honegger, J. (1992) Addendum to MSL-10576: Aerobic Aquatic
Metabolism of ocarbon 14a Glyphosate: Supplement to MRID
41723601: Unpublished study prepared by Monsanto Agricultur
Comp. 6 p.
42383201 Goure, W. (1992) Aquatic Dissipation of Glyphosate and AMPA
Water and Soil Sediment Following Application of Glyphosate
Irrigated Crop and Forestry Uses: Addendum to
MSL-8332/Supplement to RD 898. Unpublished study prepared b
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 Monsan
Agricultural Co. 555 p.
42372504 Honegger, J. (1992) Addendum to MSL-9811: Confined Rotationa
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. 1
41543201 Nicholls, R. (1990) Confined Rotational Crop Study of Glypho
Part I: In-Field Portion: Lab Project Number: EF-88-22.
Unpublished study prepared by Pan-Agricultural Labs., Inc.
C-32
-------
p.
41543202 McMullan, P.; Honegger,J.; Logusch, E. (1990) Confined
Rotational Crop Study of Glyphosate Part II: Quantitation,
Characterization and Identification of Glyphosate and Its
Metabolites in Rotational Crops: Lab Project Number: MSL-981
Unpublished study prepared by Monsanto Agricultural Labs. 8
42372505 Goure, W. (1992) Addendum to MSL-7633: Irrigated Crop Study.
Determination of Glyphosate Residues in Crops, Irrigation Wa
Sediment and Soil Following Treatment of Irrigation Source w
Rodeo Herbicide: Supplement to MRID 40541305: Unpublished s
prepared by Monsanto Agricultural Comp. 22p.
40541305 Kunstman, J. (1988) Volume 5: Irrigated Crops
Study--Determination of Glyphosate Residues in Crops, Irriga
Water, Sediment, and Soil following Treatment of Irrigation
Source with Rodeo: Laboratory Project No. MSL-7633. Unpubli
study prepared by Monsanto Agricultural Co. 203 p.
41228301 Forbis, A. (1989) Uptake, Depuration and ioconcentration of
Carbon 14-Glyphosate to Bluegill Sunfish (Lepomis macrochiru
Project ID MSL-9304. Unpublished study prepared by Analytic
Biochemistry Laboratories, Inc. 425 p.
40541301 Bodden, R.; Patanella, J.; Feng, P. (1988) Volume 1:
Metabolism Study of Synthetic ^Carbon 13/Carbon
14 —Labeled Glyphosate and Aminomethylphosphonic Acid in
Lactating Goats: Laboratory Project No. HLA 6103-113:
MSL-7458. Unpublished study prepared by Monsanto Co. 129p.
40541302 Bodden, R.; Feng, P.; Patanella, J. (1988) Volume 2:
Metabolism Study of Synthetic ^Carbon 13/Carbon
14 --Labeled Glyphosate and Aminomethylphosphonic Acid in
Laying Hens: Laboratory Project No.: HLA 6103-112:
MSL-7420. Unpublished study prepared by Monsanto Co. 126p.
40541303
Pijanowski, P. (1988) Volume 3: Validation of an Analytical
Method for the Determination of Glyphosate Residues in
Animal Tissues: Laboratory Project No. MSL-7358.
Unpublished study prepared by Monsanto Co. 65 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.
C-33
-------
00159419 Kuntsman, J. (1985) Validation of a New Residue Method for Analys:
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
C-34
-------
Fractions following Recirculating Sprayer and Preharvest Topic;
Treatments with Roundup Herbicide: Report No. MSL-3259: Project
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: OGlyphosate . Includes undated
method entitled: Analysis of Glyphosate in cranberries; undatec
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 Processii
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.
40502604 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 Number: MSL-9797. Unpublished study preparec
by Monsanto Agricultural Co., in cooperation with Texas A&M
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 Kuntsman, 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.
C-35
-------
138 p.
41484301 Allin, J. (1989) Glyphosate Residues in Wheat Grain and Straw afte
Preharvest Treatment with Roundup Herbicide: R.D. No. 983.
Unpublished study prepared by Monsanto Agricultural Co. 436 p,
00150835 Monsanto Co. (1984) YGlyphosate Residues in Wheat Grain, Straw anc
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 anc
Seed following Scattered Spot Treatment with Roundup Herbicide;
Laboratory Project No. MSL-7482. Unpublished study prepared b^
Monsanto Co. 121 p.
40642401 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 Coffee 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: Projec
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.
C-36
-------
00144341 Steinmetz, J. (1984) Glyphosate Residues in Peanuts and Peanut
Fractionation Products Following Postemergent Polyester/Acrylic
Pipewick Treatments with Roundup Herbicide: Report No. MSL-339^
Job/Project No. 7163. Unpublished study prepared by Monsanto
Co. in cooperation with ABC Laboratories, Inc. and Craven Labo]
atories, Inc. 116 p.
40541305 Kunstman, J. (1988) Volume 5: Irrigated Crops Study--Determinatic
of Glyphosate Residues in Crops, Irrigation Water, Sediment, ai
Soil following Treatment of Irrigation Source with Rodeo: Labo-
ratory Project No. MSL-7633. Unpublished study prepared by Moi
santo Agricultural Co. 203 p.
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 YCarbon-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 YCarbon 14"-
Glyophosate and "Non-aged" Sandy Loam Soil Substrate, Part I ai
Part II. Unpublished compilation prepared by Monsanto Co. 324j
C-37
-------
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 for 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
-------
i
Appendix E
Pesticide Reregistration Handbook
-------
-------
i
PESTICIDE SERESISTRATIQH HANDBOOK
HOW TO RESPOND TO THE
REREGISTRATION ELIGIBILITY DOCUMENT (RED)
OFFICE OF PESTICIDE PROGRAHS
ENVIRONMENTAL PROTECTION AGENCY
OCTOBER 1991
,- -
••t '!*•
-------
-------
PRODUCT REREGISTRATIOK HANDBOOK
TABLE Of CONTENTS
I. Introduction
A. Purpose and Content 1
B. Rercgistration Eligibility Document 1
C. Rercgistration Process 1
IX. Instructions for Responding
A. How and When to Respond . 2
B. When No Response Is Needed 5
B. Where to Respond 6
III. Submission of Data and Labels/Labeling
A. Generic Data 6
B* Product Specific Data 7
1, Product Chemistry 7
2* Acute Toxicity 8
3. Product Performance 9
C. Labels/Labeling 10
Appendix
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}
-------
i
-------
PESTICIDE REREGISTRATION HANDBOOK
I. INTRODUCTION
A. gurpQge and Contentof this Handbook
This Handbook provides instructions to registrants on how to
xespond to the Rercgistration 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 labels/labeling which may be required to be submitted.
Detailed instructions are in the Appendix.
B. The Reregistration Eligibility __poeument tREDJ
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-ln
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 Reregistration 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.
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.
-------
i
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 BED, registrants must
submit or cite any data and labels/labeling required for each
product. EPA has until 14 months after the RID 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 l inert is permitted only if all data
for it have been submitted and EPA determines
that the inert does not pose any unreasonable adverse
effects in that product).
Products which meet all of these criteria will be*
reregistered. 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..
XX. INSTRUCTIONS FOR RESPONDING •
A. Hov 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 toe active ingredient in the RED [i.e.,
manufacturing use products, end use products and special local need
(8LN or Section tic) registrations] are subject to the requirements
of the RED. Figure I summarizes how and when to respond to the
RED. A step-by-step explanation follows.
Step 1. Ajre Expedited Label Ch&naes Required? in some
instances, EPA may conclude that certain changes to product
labels/labeling must be implemented rapidly. Xf the RED requires
expedited label/labeling changes, registrants must submit the items
below by the deadline specified is the RED. Xf expedited label
changes are not required, go to Step 2.
a. Application for Registration (EPA Form 8570-1). Complete
-------
and sign the font. In Section II, insert the phrase "Expedited,
Amendment in Response to the Reregietration Eligibility Document
for (insert ease name for chemical) .** Applications for expedited
label changes will be processed as applications for amended
registration, use only am original application font with a red
identifier number in ':he upper right-hand corner.
b. Five (5) copies of revised draft label and labeling.
Refer to the RED for label/labeling changes and follow the
instructions in Section III.C. and the Appendix of this Handbook
for revising the label and labeling for each product.
Btep-^£. Are data requ.Ve:dl X? the RED requires generic or
product specific data, you must follow the directions in the data
call-in notice in the RED. All registrants Bust respond for all
products within 90 flays of receipt; products for which an adequate
response is not received on time will be subject to suspension. No
timeextensionswill be given fpyresponding within 90days.
gtep_^. Are Uses of a _Pe_stlcige Eligible for Rereqistra^lop?
If any uses of the active ingredient (s) covered by the RED are
eligible for reregistration, follow these instructions. If no uses
are eligible, pp 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 (HP«), end-use products (EPS) and
special local needs registrations (SLNs), Bust submit the items
below for each product within S months of the date of issuance of
the RED:
a. Application for Reregistration (use EPA Perm 8570-1).
Complete and sign the form. In Section II of that form, check the
box "Other" and insert the phrase "Application for Reregistration.11
Use only an original application form with a red identifier number
in the upper right-hand corner.
b. Five (5) copies of revised draft label and labeling.
Refer to the RED for labeling changes specific to the active
ingredientr follow the instructions in Section III.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.
-------
i
FIGURE 1. BOW 1KB VEEN TO RESPOND TO THE REREGISTRATION
ELIGIBILITY DOCDHENT (RED) FOR KANUPACTURING USE
PRODUCTS (MPs), END-USE PRODUCTS (EPS) tad SPECIAL
LOCAL HEEDS REGISTRATIONS (8LHS).
STEP it A.-e expedited label revisions required?
¥es ^r No
m^
Submit application
and labels on
expedited schedule
specified in RED.
STEP 2:
STEP 3:
Are data required?
Yes >^ Ho
r
Submit fonts within
to days for generic
and product specific
data.
Are any of the uses on the label
eligible for reregistration?
Yes
Are any uses on the label
ine.ligj.ble. for reregistration?
Yes
Do you wish to
dej-etj* ineligible
uses from label?
No
For each HP i IP
i 8LN <24c) submit
application within
8 months. If
the submission
is acceptable,
the label vill be
stamped accepted
as an amendment.
Ho reregistration
vill be issued.
Yes
For each MP i EP
i SLN (24c) submit
applieatioa vithin
8 months, if
•the submission
is acceptable,
the label vill be
stamped accepted
and a notice of
reregistration
vill be issued.
No further response
necessary. Await
the outcome of
EPA's review.
-------
i
c. Product Specific Data. You Bust follow the instructions
ia the Data Call-in Notice ia toe RED and ia section III of this
Handbook. Responses to the data call ia are due within AILJiays of
receipt of the RED and submission or citation of data is due within
a Boa^ba of the issuance of the RED.
d. Two (2) copies of the current Confidential Statement of
Formula (EPA Font 8570-4, revised February 85). Two completed and
signed CSF forms must be submitted for the basic formulation and
for each alternate formulation. Zf 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 fora.
e. Certification With Respect to Citation of Data (EPA Form
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. Wfcep ffo Response is l^^efled
Zf no uses of a pesticide are eligible for rercgistration, it
is unlikely that you will be required to submit product specific
data or labeling. Uses of an active ingredient may be declared
ineligible for 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.
Zn 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. Zf
some or all of the previously ineligible uses become eligible for
reregistration, EPA will start the reregistration process for
products containing only eligible uses.
Zn 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).
Zn such cases, the chemical's uses will not be eligible fbr
reregistration until the additional 'generic data have been
submitted to and reviewed and found acceptable by EPA. Zf 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.
Zf the data are not submitted, products containing the active
ingredient may be suspended.
-------
I
C. Where -to Respond
By U.S. Mail;
Document Processing Desk {insert distribution code)
Office of Pesticide Programs (H7504C)
Environmental Protection Agen<2y
401 H Street, S.W.
Washington, D.C. 20460-0001
By express mail or by hand delivery:
Document Processing Desk (insert attribution code)
Office of Pesticide Programs (H7504C)
Room 266A, Crystal Hall 2
1921 Jefferson Davis Highway
Arlington, VA 22202
'These mailing addresses and the following distribution codes
sust be used to assure the timely receipt and processing of your
submissions. Mot using them may significantly delay the handling
of your submissions:
RED-SRRD-xxx (where xxx is the case- eode given on the front of
the RED)—use this distribution code for all responses pertaining
to or containing generic da^a. Such responses include the 90-day
response forms for generic data or hard -copies of generic data.
RED-RD-PMxa: (where xx is the Product Manager team 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 must 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. Zn 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.
-------
i
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 Dal 1-In Notice in the RED,
registrants oust 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. ProductSpepifip Data
Product specific data may be required for the reregistration
of each pesticide product in three areas—product chemistry, .acute
toxicity and efficacy.
!• 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 HPs, EPS and SLNs (24c's) are
specified in the Data Call-in Notice in the RED. In addition:
--If you cite data from another identical, registered
product, you oust 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 vas 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 Jcnown inert ingredients into four
categories:
—Inerts of toxicological concern (List 1) for which available
data demonstrate toxic effects of concern (includes about 50
chemicals).
-------
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 are available (includes up to
2,000 chemicals).
— Inerts of minimal concern (List 4) which are generally
regarded as innocuous (includes about 290 chemicals) .
When a RED is issued and any uses of an active ingredient are
declared eligible for reregistration, all products eontainir-n that
active ingredient will be 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
will be unaffected by the inerts strategy.
Consistent with the strategy on inerts, * product containing
a List 1 inert ingredient will not be reregistered until a full
risk assessment of the product lias been conducted, based OB 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 reragistration.
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.
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
-------
sain 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 nay choose to conduct their own studies.
3. Product Performance
i
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 nice,11 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. EjffAcaey^Pjita__Subj>j._s_sio_n Waiver_Pol4cy
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.
-------
10
• «..
b. glains and Products for Which Efficacy Data Genera3Jy
Are Required
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
say 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
To remain 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
n«w uses or labeling changes that do not pertain to reregistration
aust 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 (PR)
Notices, regulations, regulatory decisions and policies issued by
EPA which are relevant to the pesticide. Your1 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.
-------
I
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}
-------
i
-------
Conf/dfnttff Bugtnnt tnformmttan: Pan Mot Contain N*tfon»l Scciffff]
tnform»tlon (C.O. 120951
ton*
MM No MMMOM. Af
oEPA
WMMngtao. OC IO4BO
Confidential Statement of Formula
D
AtMmaM FermutMton
SOT (rtttfueUotw MI 8wk
i. mma *no AoorM* 01 Appnc»nj/Rini»ir«nc fintfuae at* t (we/
2. Name sncl Address of Producer (Include ZIP Code)
3, PlWMCI H»m»
4, R«rMr«tk>n No /FH» Symbol
f. Powxh/Ort «f Buft OwwNy
8. EPA ff oduct Mr/T*tcn No
em use ONLY
11. Suppltor NMIM • Ad»*M
II. EPA ft*. No.
•. Amount % «tf NM|li
14 CwtlMUnMfi
18. Typed Nairn of Approving Official
17 Total Weight
18 Sianaluro of Approving OffM»l
FPA Putin HUTU.* MM »-•*« fc—J— -"««-
19. Till*
10. ffwn* No. fftwtafc
-------
Instruct ions for Completing j£he Confidential Statement jaf
forpula
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. nil 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 12.
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. •
-------
.B. INSTRUCTIONS FOR IABEI, COHTEHTS
40 CFR 156.10 and Pesticide Regulatory (F.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 vill not be accepted if
it is false or misleading. [40 CFR 156.10(b))
Item 2. COMPANY NAME AND ADDRESS - The name and address of the
producer, registrant or person for whom the product -is produced are
regui4.~d 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 end of the label text. The net
contents must be expressed in the largest suitable unit, e.g., "1
pound 10 ounces" rather than "26 ounces.* In addition to English
units, net contents may be expressed in metric units. [40 CFR
156.10(d) 3
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.,11 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
EPA has reclassified chemicals from inert ingredient status to,
active ingredient status,* registrants of affected products must'
change the 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.
Item 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"
i|j Square Inches All Capitals M4nimum ,T_ype__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 156.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING, or
CAUTION) is required on the front panel immediately below the child
hazard warning statement. {40 CFR 156.10(h)(1)(i)].
-------
Item 7C. SKULL i CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal, or
inhalation toxicity, the vord "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)(1)(i)}.
Item 7D. STATEMVJfT OF PRACTICAL TREATMENT - A Statement Of
practical treatment (first aid or other} shall appear on the label
of pesticide prod acts in toxicity Categories I, II, and III. [40
CFR 156.10(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT - the statement "see Side (or Back)
Panel for Additional Precautionary Statements" is required on the
front panel for all piquets, unless all required precautionary
statements appear on the front panel. (40 CFR 156.10(h)(l)(iii)].
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The precautionary
statements listed below must appear together on the label under the
heading "PRECAUTIONARY STATEMENTS." The preferred location is at
the top of the side,or back panel preceding the directions for use,
and it is preferred that these statements be surrounded by a block
outline. Each of the three hazard warning statements must be
headed by the appropriate hazard title. [40 CFR 156.10 (h) (2)]
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a hazard
exists to humans or domestic animals, precautionary statements are
required indicating the particular hazard, the route (s) of exposure
and the precautions to be taken to avoid accident, injury or
damage. - [40 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)J
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY Precautionary
statements relating to flammability of a product are required to
appear on the label if it meets the criteria in the PHYS/CHEM
Labeling Appendix. The requirement is based on the results of the
flashpoint determinations and flame extension tests required to be
submitted for all products. These statements are to be located in
the side/back panel precautionary statements section, preceded by
the heading "Physical/Chemical Hazards." Note that no signal word
is used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d) requires
that all pesticide formulations/uses be classified for either
general or restricted use. Products classified for restricted use
may be limited to use by certified applicators or persons under
their direct supervision (or may be subject to other restrictions
that may be imposed by regulation). If your product has been
classified for restricted use, then these requirements apply:
-€ •*:
-------
1. All 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. The statement "Restricted Use Pesticide" must appear at
the top of the front panel of the label. The statement
'must be set in type of the same minimum siie as required
for human hazard signal word [see table in 40 CTR
156.10 (h) U) (iv)]. No statements of any kind may appear
above this RUP statement. .
b. The reason,for the the restricted use classification must
appear below the RHP statement. The RED will prescribe
this statement.
c. A summary 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 supervision and only for those uses covered
by the Certified Applicator's Certification.** The RED
will specify what statement must be used.
2. some but not all uses restricted. If the RED states that some
uses are classified for restricted use, and some are
unclassified, several courses of action are available:
a. You may label the product for Restricted use. If you do
so, you may include on the label uses that are
unrestricted, but you may not distinguish them on the
label as being unrestricted.
b. You may delete all restricted uses from your label and
submit draft labeling bearing only unrestricted uses.
.. c. You may * split" 'your registration, i.e., register two
separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted
• 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
-------
I
accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are required to
bear storage and disposal statements. These statements are
developed for specific containers, sizes, and chemical content.
These instructions must be grouped and appear under the heading
•Storage and Disposal" in the directions for use. This heading
must be set in the same type sizes as required for the child hazard
warning. Refer to P.R. Notices 83-3 and 84*1 to determine the
storage and disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must be stated
in terms which can be easily read and understood by the average
person likely to use or to supervise the use of the pesticide.
When followed, directions must be adequate to protect the public
from fraud and from personal injury and to prevent unreasonable
adverse effects on the environment. [40 CFR 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 those accepted in connection with
registration of the product. Collateral labeling must be made part
of the response to the.RED and submitted for review.
-------
f
-------
LABEL FORMAT FOR UNCLASSIFIED PRODUCTS
-
II
II
1
1
•
I
' ! ' *t
f
turn
§i
flC CO "
i°|||
* *
*
s
1
•
1 '
* * I* 1
1— 1 r
Sis
o<
!; •••••'!•
i , !
cc 11 I
Q_ {I -' f
ii § I
' , ,*|
I
=J I
s z i
u. • fc. • J
§ Q 1
ID I
g (J 1
o i
ii Ss
» t * »
1
«•» *
'I
*
tf
1 es *
1 it
I ef |
stpi
.
*
I Hi
If!"
i 1
i g
iw 1
1 if 1
S !' !
1 Ift S
•
*
4» 1
1 111
I
-------
rneCAUTONAHV IfAftMEMff
HAf AMI TO HUMANS
I OOMISNC ANMAl*
OANQtft
HAtAflM
UMCHONl fW WK
I » I MMAM tf f d*Wl
Mt •*•*•! H • UMPtW
IMKNIIIViRMttMINr
HI
^STORAGE AND
DISPOSAL
•fOMOIl
OOPOSM,;
RESTRICTED USE
PESTICIDE
Due to (insert reason*)
*a*RMi. MU m NR» wi wur it cnmnn AmjantM CM
*1125™ Wini Wi8cr WWWKM *» «•" »« west
awoca M iw ctmrtto nrrucMm'a
(*for example, "Due to high acute toxiclty.11)
PRODUCT
NAME
ACTWf MOH[PCNf:
i
i
TOTAL
in OP MMOMI.ON
KEEP OUT OP REACH OP CHILDREN
DANGER-POISON
imfttMNi at raAcncM.
PWMtti
PtMMID:
VON INN:
fMfYfi:
•it mm ram. ran noomoMM. PWOMITONMIV w Annum
' ISTAtUSMMCNT NO,
IPA HCO«T MIKMI NO,
NfTCONflNIt:
OlOPt;
CNOf!
WAIWANTTtTATCMIMT
p
o
H
I
n
H
en
3
i
OT
en
w
-------
^roUef Ion Agency
has asserted a confidential
information claim concerning
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-
ZEAL 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: 1 UJB.C. 136-136y.
1156.10 Labeling requirement*.
(a) General—(1) Contents of the
label Every pesticide products shall
bear a label containing the informa-
tion specified by the Act and the regu*
-------
1156.10
lations in this Part. The contents of a
label must show clearly and promi-
nently the following:
(1) The name, brand, or trademark
under which the product is sold as pre-
scribed in paragraph (b) of this see-
don;
(li) The name and address of the
producer, registrant, or person for
whom produced as prescribed in para*
graph (c) of this section;
Oil) The net contents as prescribed
in paragraph (d) of this section;
Civ) The product registration
number as prescribed in paragraph (e)
of this section; .
(v) The producing establishment
number as prescribed in paragraph Cf >
of this section;
(vi) An ingredient statement as pre-
scribed in paragraph (g) of this sec-
tion;
(vii) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section;
(viii) The directions for use as pre-
scribed in paragraph (i) of this section;
and
The use classiflcation(s) 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 custom*
-ary conditions of purchase and use.
(ii) All required label text must:
-------
Agency
false of misleading statement
Concerning the effectiveness of the
product as a pesticide or device;
(ill) A false or misleading statement
.bout the value of the product for
purposes other than as a pesticide or
device;
(iv> A false or misleading comparison
with other pesticides or devices;
Cv) Any statement directly or indi-
rectly implying that the pesticide or
device is recommended or endorsed by
any agency of the Federal Govern-
ment;
Non-numerical and/or compara-
tive statements on the safety of the
product, including but not limited to:
(A) "Contains all natural ingredi-
ents";
(B) "Among the least toxic chemi-
cals known"
CO "Pollution approved"
(6) Final printed labeling, (i) Except
as provided in paragraph (a)(6XiI> of
this section, final printed labeling
must be submitted and accepted prior
to registration. However, final printed
labeling need not be submitted until
draft label texts have been provision-
ally accepted by the Agency.
(11) Clearly legible reproductions or
photo reductions will be accepted for
unusual labels such as those silk*
screened directly onto glass or metal
containers or large bag or drum labels,
Such reproductions must be of micro-
film reproduction quality.
$156.10
(b) Name, brand, or trademark. (1)
The name, brand, or trademark under
which the pesticide product is sold
•hall appear on the front panel of the
label.
(2) No name, brand, or trademark
may appear on the label which:
Ci) Is false or misleading, or
CM) Has not been approved by the
Administrator through registration or
supplemental registration as an addi-
tional name pursuant to 1 152.132.
(c) Name and address of producer,
registrant, or person for whom pro-
duced. An unqualified name and ad-
dress given on the label shall -be con-
sidered as the name and address of the
producer. If the registrant's name ap-
pears on the label and the registrant is
not the producer, or if the name of the
person for whom the pesticide was
produced appears on the label., it must
be qualified by appropriate wording
such as "Packed for * » *,*' "Distribut-
ed by " * V* or "Sold by ..... to show
that the name is not that of the pro-
ducer.
(d) Net weight or measure of con-
tents. (1) The net weight or measure
of content shall be exclusive of wrap-
pers or other materials and shall be
the average content unless explicitly
stated as a tntntT^ifn quantity.
(2) If the pesticide is a liquid, the
net content statement shall be in
terms of liquid measure at 88* F (20'C)
and shall be expressed in conventional
American units of fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide is solid or semi-
solid, viscous or pressurized, or is a
mixture of liquid and solid, the net
content statement shall be in terms of
weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be
stated in terms of the largest suitable
units. Le., "i pound 10 ounces", rather
than "26 ounces."
CS) In addition to the required units
specified, net content may be ex-
pressed in metric units.
C6) Variation above mintTmm* eon-
tent or around an average is permissi-
ble only to the extent that it repre-
sents deviation unavoidable in good
manufacturing practice. Variation
below a stated »«fo<"*^Tn is not permit-
ted. In no case shall the average con-
-------
§ 156.10
tent of the packages to * shipment fall
below the stated Derate content.
on whlut appears and shall run par-
SeT to It. The registration number
and the required identifying phrase
S£l not appear to such a manner as
to suegest or Imply recommendation
or endorsement of the product by the
Agency*
(f> Producing establishments regis-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA Est.", of the
final establishment at which the prod-
uct was produced may appear in any
suitable location on the label or imme-
diate container. It must appear on the
wrapper or outside container of the
package if the EPA establishment reg-
istration number on the Immediate
container cannot be clearly read
through such wrapper or container.
(g) Ingredient statement— (.1) Gener-
al The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active ingredient, the total per-
centage by weight of all inert ingredi-
ents; and if the pesticide contains ar-
senic to any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active ingredients must be
designated by the term "active ingredi-
ents" and the inert ingredients by the
term "Inert Ingredients," or the singu-
lar forms of these terms when appro-
priate. Both terms shall be in the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" is
not required for pesticides which con-
tain 100 percent active ingredients.
Unless the ingredient statement is a
complete analysis of the pesticide, the
term "analysis" shall not be used as a
heading for the ingredient statement.
(2) Position of ingredient statement
(!) The ingredient statement is nor-
mally required on the front panel of
40 CFR Ch. I (7-1-89 Edition)
label. If there is mn outside con.
tmer °* wraPP*1" though which the
ingredient statement cannot be clearly
read, the ingredient statement must
also appear on such outside container
or wrapper. If the size or form of the
package makes it impracticable to
place the ingredient statement on the
front panel of the label, permission
may be granted for the ingredient
statement to appear elsewhere.
(II) The text of the ingredient state-
ment must run parallel with other
text on the panel on which it appears,
and must be clearly distinguishable
from and must not be placed to the
body of other text.
(3) Names to be used in ingredient
statement. The name used for each In-
gredient shall be the accepted
common name, if there is one, fol-
lowed by the chemical name. The
common name may beoised alone only
if it is well known. If no common name
has been established, the chemical
name alone shall be used. In no case
will the use of a trademark or proprie-
tary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of section 25(c)(6).
(4> Statements of percentages. The
percentages of ingredients shall be
stated to terms of weight-to-weight.
The sum of percentages of the active
and the inert ingredients shall be 100.
Percentages shall not be expressed by
a range of values such as "22-25%." If
the uses of the pesticide product are
expressed as weight of active ingredi-
ent per unit area, a statement of the
weight of active ingredient per unit
volume of the pesticide formulation
shall also appear to the ingredient
statement.
(5) Accuracy of stated percentages,
The percentages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-
turing batches, the value stated for
each active Ingredient shall be the
lowest percentage which may be
present.
(8) Deterioration. Pesticides which
change to chemical composition sig-
nificantly must meet the following la-
beling requirements:
78
-------
CD
Agency
la cases where It is determined
pesticide formulation changes
composition significantly,
must bear the following
^ in a prominent position on
libel: "Not for sale or use after
rdateJ."
The product must meet all label
js up to the expiration time indi-
fl on the label.
(7 inert ingredients. The Adminis-
trator may require the name of any
toe t ingredient(s) to be listed in the
ingredient statement if he determines
Uiat such ingredient(s) may pose a
bizard to man or the environment.
(h) Werf*nffs and precautionary
statement*. Required warnings and
precautionary statements concerning
§ 156.10
the general areas of lexicological
hazard including hazard to children,
environmental hazard, and phyiical 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.
CD 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*.
Y*MM^MIk> •Mt^MMMi^^
lODOiy GMNpOIWf
HI
IV
Up to «nd ftduovq so
DmntfLO*
Up lo and including £
ims/DMr.
Up to «nd irxAxSng 200
From 10 thru 500 mg/k§.
Pram .2 Ihru 2 mg/«K_.
FIQRI 200 tfni SKW ii-
ComMl opaelty
iMnibl*
7 a»y».
from 900 Mu 5000 ng/
Fiwn 2. ttni 20 me/m*,
Pwm 2,000 «n» 20.000™
No comMJ opacity:
Mtttion imtrttUt
Tfliyt
GfHttr Vwn SOOO m§/
&**ttrtfwn:
20,000,
Stan i
Sw«« feiittlion «t 72
hour*
hours
l«72
MM or SK0M MWion «
72 hours.
(i) HuTnan hazard signal toond—(A)
Toxictty Oa2e0ory /. All pesticide prod-
ucts meeting the criteria of Toxicity
Category I shall bear on the front
panel the signal word "Danger." In ad-
dition if the product was assigned to
Toxicity Category I on title basis of its
oral, inhalation or dermal toxldty (as
distinct from skin and eye local ef-
fects) the word "Poison" shall appear
in red on a background of distinctly
contrasting color and the skull and
crossbones shall appear In immediate.
proximity to the word "poison."
(B) Toxicity Category II. All pesti-
cide products meeting the criteria of
.Toxicity Category II shall bear on the
front panel the signal word "Warn-
ing."
(C) Toxicity Category III. All pesti-
cide products meeting the criteria of
Toxicity Category HI shall bear on
the front panel the signal word "Cau-
tion."
(D) Toxicity Category IT, All pesti-
cide products meeting the criteria of
Toxicity Category IV shall bear on the
front panel the signal word "Caution."
(E) Use of signal words. Use of any
signal word(s) associated with a higher
Toxicity Category is not permitted
except when the Agency determines
that such labeling is necessary to pre-
vent unreasonable adverse effects on
man or the environment. In no case
shall more than one human hazard
signal word appear on the front panel
of a label.
(U) Child hazard warning. Every pes-
ticide product laoel shall bear on the
front panel the statement "keep out of
reach of children," Only in cases
where the likelihood of contact with
children during distribution, market-
ing, storage or use is demonstrated by
the applicant to be extremely remote,
or if the nature of the pesticide is such
79
-------
1156.10
that it i* approved for use on Infants
or small children, may the Administra-
tor waive this requirement.
CiilJ Statement of practical treat-
ment— *
statement of practical treatment (first
aid or other) shall appear on the front
panel of the label of an pesticides fall-
ing into ToxicitF Category I pn the
basis of oral, inhalation or dermal tox-
Jdty. The Agency may, however,
permit reasonable variations to 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"
ana t>» skull and crossbones.
(B) OJter toxicity categories. The
statement of practical treatment is not
required on the front panel except as
described in paragraph (hXIXiliXA) of
this section. The applicant may, how-
eve:* include such a front panel state-
ment %t his option. Statements of.
practical treatment are, however, re-
quired elsewhere on the label in
accord with paragraph (h)(2) of this
section if they do not appear on the
front panel.
(iv) Placement and prominence. All
the require front panel warning state-
ments shall be grouped together on
the label, and shall appear with suffi-
cient prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use. The following table
shows the tnhiimtun type size require-
40 CFH Ch. I (7-1-if Idltion)
ments for the front panel warning
statements on various sizes of labels:
Sis* or labai *rontpa«ai * «•*•»
Sandunds
51010-
Abova 101015.
aignai
word, ail
10
12
14
16
I
10
It
(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
/'Physical 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.
Tabcrty
catagory
PwcaufiOBaiy statarnants by tnocrty category
Oral. hhaJafen. or tfarmal
Stun and ay* toca)
W.
IV.
Fatal (poisonous} I swaBowad EtohaJad or absorbad
trough akin]. Do not braatna vapor [dust or spray
nwt]. Do net gat at ayaa. on akin, or on etotning
[Fforrt panal stalamant of practical traatmant ra-
May bt fatal tf aiMllpwact Clnhaiad or
through ttw akinl. Do net eraatti* vapors tdu«t or
•pray tniat]. Do not gat in ayaa. on akin, or en
ctotlnoy, [Appnjpriaii flrat aid atatatnants raoiarad.].
HarmhH If awaflowad Onhalad or abaorbad through ttw
akin]. Avoid braathing vapors [dual or spray MM].
Avoid eontact with atari {ayat or clothing]. [Appro-
priata first aid atatamant rsquirad.].
{No praeaulienary atatsmants raquinad]
Conosiva. eauaas aya and akin damaga [or akin
kritation]. Do not gat in ayaa, on akin, or on
tioMng. Waar gogglas or fact aMatd and jifcper
gkjwas whan handling. Harmful or fatal If swaNowad.
[Appropnata flrat aid statainant raojjirao'.j
Causas aya land akinl irritation. Do not gat m ayaa,
on skin, or en clothing. Harmful N awaHowad. lAp-
propriata first aid statamant raqwrad.1
QOfwKSf 1Wtft Vyft, 9y9V Of CIOVWI00 IR OBM Gn
oontaet immadiataty flush ayas or akin with planty of
walar. Qat mablcal anantion I kritation parsists.
[No praeautionary statamants raqulrad.1
80
-------
b
trial Protection Agency
Where a
non target
humans and domestic ani-
**T.T nreeautionary statements are re-
0*r/ stating the nature of the
and the appropriate preeau-
to avoid potential accident,
or damage. Examples of the
statements and the dream-
tinder which they ai*. required
tA> i* * P<^ticide intended for out»
400r use contains an active Ingredient
-rfth a EPBiTTiTTt*-^*" acute oral LD** of
or less, the statement "This Pesti-
is Toxic to Wildlife" is required.
HI) If a pesticide intended for out-
4oor use contains an active ingredient
Jt3i a fish acute LC* of 1 ppm or less,
lite statement "This Pesticide is Toxic
to Fish" is required.
If a pesticide intended for out-
door use contains an active ingredient
with an avian acute oral LD« of 100
tag/kg or less, or a subacute dietary
§156,10
LCt* of 500 ppm or less, the statement
This Pesticide is Toxic to Wildlife" is
required.
CD) If either accident history or field
studies demonstrate that use of the
pesticide may result in fatality to
birds, fish or ?«*mm*iK 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. .
(P> 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:
AaqwnMtaxt
(A) PMSSUWZeO CONTMNfltS
point ft or
20*
'. lhara is a flashback at
FMipoM •bpv*23* F«d Ml Ov*r KT F or H t»
•mw «MraJon • more fwn tt In long tt
et 9 in torn 9m 9mm,
Contam§ undar oraaaura. Kaap away
•ra, aparkt, «nd naaMd aurtaoat. Do not emetura or momanm
oontainaf. Expoaurv to tampvraturaa flboyf 130* f (My
tenting
•parks, ami op*n Hum, Do not punelura or ineinarata <
Expowra to umpatiiuraa aoowa 110* f nay eauw burning.
Al mm prmunaKi cormiBira.-. „.... , „ , —
MxuMHft unowr praMura. OB not UM or nora nnr i
Mm. Do not Dunettrc or InpincnM eontiintr.
Mmpcratum •bovo 130* f may eauM bunting.
nm or open
ijowaura ^
9) rttMMUMimiTtn OantuHU»
ttftokrMiert.,.-, - , . . . .....
AfrWt KT F W«f •*» Wf Ifff P „,„,„„-,-„-„-,,„-„„-„,,, , „ --,
Exfrwnaly Hamnabla. Kaap aw«y tram fm, aparto,
awtaeas.
Do not MM or «ora naar haat or apan flatna.
and haatad
(i) Directions for Use—
-------
i 156.10
(B) The libel bears e 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.
(iii) Exceptions to requirement for
direction for use— Detailed direc-
tions for use may be oooitted from la-
belLng of pesticides wj» ,ch are intended
for use only by manufacturers of prod-
nets other than pest cide products in
their regular manufacturing processes,
provided that:
CD The label dearly shows that the
product is intended for u:* only in
manufacturing processes and specifies
the type(s) of products involved.
(2) Adequate information such as
technical data sheets or bulletins, is
available to the trade specifying the
type of product -involved and its
proper use in manufacturing process-
es;
C3) The product will not come into
the hands of the general public except
after incorporation into finished prod-
ucts; and
(*) 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:
CD The label clearly states that the
product is for use only by physicians
or veterinarians;
C2> 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.
CO Detailed directions for use may
be omitted from the labeling of pesti-
cide products which are intended for
use only by f ormulators in preparing
pesticides for sale to the public, pro-
vided that:
CD There is information readily
available to the formulators on the
composition, toxicity, methods of use,
applicable restrictions or limitations,
40 CFR Ch. I (7-149 Edition)
and effectiveness of the product tot
pesticide purposes;
C2) 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;
(J) The product as finally manufac-
tured, formulated, mixed, or repack-
aged is registered; and
CO The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
C2) Content* of Directions for Use.
The directions for use shall include
the following, under the headings "Di-
rections for Use":
Ci) The statement of use classifica-
tion as prescribed in paragraph (iv»
82
-------
. ylronm«ntal *¥*t»eti«i Agency
. Any limitations or restrictions on
leouired to prevent unreasonable
* effects, such as:
Required intervals between ap-
and harvest of food or feed
ff 156.10
considered a false or misleading state-
ment under the statutory definitions
clm)Rotational crop restrictions.
Warnings as required against use
AT certain crops, animals, objects, or
in or adjacent to certain areas,
CReservedl
For restricted use pesticides, a
ent that the pesticide may be
applied under the direct supervision of
ratified applicator who is not phys-
iLny present at the .site of application
but nonetheless available to the
person applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who is physically present.
Directly below this statement on
the front panel, a summary statement
of the terms of restriction imposed as
a precondition to registration shall
appear. If use is restricted to certified
applicators, the following statement is
required: "For retail sale to and use
only by Certified Applicators or per-
sons under their direct supervision and
only for those uses covered by the Cer-
tified Applicator's certification." If,
however, other regulatory restrictions
are imposed, the Administrator will
define the appropriate wording for the
terms of restriction by regulation.
(40 FR 28268. July S. 1075; 40 FR 32326.
Aug. 1, 1875; 40 FR 38571, Aug. 21. 1975. as
amended at 43 FR 5788, Feb. 9. 1978. Redes-
Ignated and amended at 53 FR 15991, 15999.
May 4. 19881
83
-------
i
-------
I
Appendix F
Generic and Product-Specific Data Call-In
-------
I
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
GENERIC AND PRO_PUCT_ SPECIFIC *"""*
DATACALL-IN NOTICE
FEB I 61994
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
Shee_t. 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
Section III below. Your response must state;
1. How you will comply with the requirements set forth in
this Notice and its Attachments 1 through 7? or
2. 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 Registrants Response Form, (see section
III-B); or
3. Why you believe EPA should not require your submission
of data in the manner specified by this Notice (see
section III-D). *
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
-------
i
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 - Why You are Receiving this Notice
Section II - Data Required by this Notice
Section III - Compliance with Requirements of this Notice
Section IV - Consequences of Failure to Comply with this
Notice
Section V - Registrants" Obligation to Report Possible
Unreasonable Adverse Effects
Section VI - Inquiries and Responses to this Notice
The Attachments to this Notice are:
1 - Data Call-in 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
Toxicology Data Requirements for Rereaistration
5 — EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms
SECTIQH 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 NOTICE
II-A. DATA REQUIRED
The data required by this Notice are specified in the
Reouirements Status and Registrant's Response Forms: Attachment 3
-------
i
(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:
703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if the
OECD recommended test standards conform to those specified in the
Pesticide Data Requirements regulation (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 t 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)£B1
NOTICES ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data_Call-in does not in
any way supersede or change therequirements of anv previous Data
Call-infsi. 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.
-------
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 FORRESPONDING 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 are: (a) voluntary cancellation, (b) delete use(s),
(c) claim generic data exemption, (d) agree to satisfy the
generic data requirements imposed by this Notice or (e) request a
data waiver(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 Form!.
(contained in Attachments 2 and 3, respectively).
The Data calj.«rin Response forms must be submitted as part of
every response to this Notice. The Requirements jstatus 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 ResponseForms and the
Requirements Status and _Reqistra_ntls_ 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 DataCall-in Response Forms
(Attachment 2), indicating your election of this option*
Voluntary cancellation is item number 5 on both Data gall-In
Response^,,,gojpnXsJ. 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.
b. Use Deletion —
You may avoid the requirements of this Notice by eliminating
the uses 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 Form
(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 Requ irements
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
-------
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;
(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 Formula11 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]i, 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 Ill-C.l. of this Notice and comprise options 1 through 6
of item 9 in the instructions for the Requirements Status and
Registrant' s_Respqnse 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,F.ojrm 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 RequirementsStatus andRegistrant'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 SpecificData 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-Cal1-In
Response Fonnf and the Requirements Status and Registrant * s
Response Formf for product specific data (contained in
Attachments 2 and 3, respectively). The Pata.._CajyLji|nr.,Response
Forp 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 Formf 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 be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
b. Satisfying the Product Specific Data Requirementsof
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 7 a and 7b (agree to satisfy the product specific
data requirements for an HUP 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 to 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
-------
i
1. Generic Data
If you acknowledge on the Generic Data Call-in Response Fona
•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 gtatus 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) 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
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 statusand
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 be 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 Registrant1^
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 requested 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 Sharein_Cost to Develop Data
10
-------
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
differences through binding arbitration.
Otion 3_. ...Offer o Share J.n th& Cost of Data Deveoment
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
of a registrant who has in good faith sought and continues to
seek to enter into a joint data development/ cost sharing program,
but the 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
Fora 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
-------
I
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
claar.lv 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 n*[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.11 The term "specimens", according to 40 CFR
12
-------
i
16O.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.'
13
-------
Option 5. Upgrading a Study
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.11 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
14
-------
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.
i
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'sResponseForm 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' sResponse 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) I 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)
Potion 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 Jji 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
-------
i
acute toxicity data and certain efficacy data and only if IPA has
indicated in the attached data tables that your product and at
least one other product are similar for purposes of depending ori
the same data. If this is the case, data may be generated for
just 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.
Option 4. Submitlbing an Existing Study — The same requirements
described for generic data (see Section III.C.I., Option 4) apply
to this option for product specific data.
Option 5. Upgrading a Study •— The same requirements described
for generic data (see Section IIX.C.l., Option §} apply to this
option for product specific data.
Option 6. citingExisting Studies — The same requirements
described for generic data (see Section III.C.I., Option 6) apply
to this option for product specific data.
Registrants who 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.l.), 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 IPA to consider the appropriateness of requiring
data for low volume, minor use pesticides. In implementing
16
-------
I
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.
(iii) Total direct production cost of product(s)
containing the active ingredient by year for the past five
years. 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.
17
-------
(v) A list of each data requirement for which you seek
a waiver. 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
requirements.
(vii) For each of the next ten years, a year-by-year
forecast of company sales (pounds and dollars) of the active
ingredient, direct production costs of product(s) containing
the 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. Recruest for Waiver of Data
Option 9, under Item 9, on the Requirements Status and
Registrant's Response Form. 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
18
-------
i
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). ft EPA determines that the, dataware required for
your product (s) . you must choose a .method of meeting the
requirements of tl^is 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. Prodpct 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. (Note: 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 toxieity 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 not
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.
SBCTIOH IV. COM8EOPEKCES OF FAILURE TO COMPLY WITH THIS NOTICE
IT7-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
19
-------
i
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 tof the following:
1. Failure to respond as required by this Notice within 90
days of your receipt of this Notice.
2. 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.
3. Failure to submit on the required schedule an adequate
progress report on a study as required by this Notice.
4. Failure to submit on the required schedule acceptable
data as required by this Notice.
5. 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).
6. Failure to submit supportable certifications as to the
conditions of submitted studies, as required by Section
III-C of this Notice.
7. Withdrawal of an offer to share in the cost of
developing required data.
8. 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,
20
-------
i
unless you commit to submit and do submit the required
data in the specified time frame.
9. Failure to take any required or appropriate steps, not
mentioned above, at any time following the issuance of
this Notice.
XV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted
within the required time) is unacceptable and constitutes a basis
for issuance of a Notice of Intent to Suspend. The grounds for
suspension include, but are not limited to, failure to meet any
of the following:
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
-------
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
use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s)
as a response to this Notice and your product is in full
compliance with all Agency requirements, you will have, under
most circumstances, one year from the date your 90 day response
to this Notice is due, to sell, distribute, or use existing
stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end
users to sell, distribute or use such existing stocks until the
stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient
for which the Agency has particular risk concerns will be
determined on a case-by-case basis.
Requests for voluntary cancellation received after the 90
day response period required by this Notice will not result in
the agency granting any additional time to sell, distribute, or
use existing stocks beyond a year from the date the 90 day
response was due, unless you demonstrate to the Agency that you
are in full compliance with all Agency requirements, including
the requirements of this Notice. For example, if you decide to
voluntarily cancel your registration six months before a 3-year
study is scheduled to be submitted, all progress reports and
other information necessary to establish that you have been
conducting the study in an acceptable and good faith manner must
have been submitted to the Agency, before EPA will consider
granting an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states
that if at any time after a pesticide is registered a registrant
has additional factual information regarding unreasonable adverse
effects on the environment by the pesticide, the registrant shall
submit the information to the Agency. Registrants must notify the
22
-------
i
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 MID 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
Cal1-In Response Forms (Attachment 2)and completed Requirements
Status 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 pall—In Response Forms need be
submitted.
The Office of Compliance Monitoring (OGM) of the office of
Prevention, Pesticides and Toxic Substances (OPPTS), EPA, will be
monitoring the data 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 - Data Call-in Chemical Status Sheet
2 - Generic DataCall-in and Product Specific Data
Call-In Responsse Forms with Instructions
3 - Generic Data Call-In and Product Specific Data
Call-pi Requirements Status and Registrant's
Response Forms with Instructions
4 - EPA, Grouping of jgnfl-Pse Products for ...Meeting.,Acute •
Toxicology Data Requirements for Rereoistration
5 - EPA Acceptance Criteria
6 — List-jpf Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms
23
-------
i
-------
i
Attachment 1
Chemical Status Sheet
-------
i
-------
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 andProduct
Specific PCI Requirements Status and Registrant's 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 Prank 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
-------
I
-------
Attachment 2
Generic DCl and Product Specific DCI Response Forms with
Instructions
-------
-------
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 type of data call-in (generic
or product specific) is indicated in item number 3 ("Date and
Type of DCI") on each form. BOTH "Data Call-in Response11 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 HOT 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.
-------
i
INSTRUCTIONS FOR COMPUTING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-in
Item l. OH BOTH FORMS: This item identifies your company name,
number and address.
Item 2. OH BOTH FORMS: This item identifies the case number,
case name, EPA chemical number and chemical name.
Item 3. OH BOTH FORMS: This item identifies the type of Data
Call-in. The date of issuance is date stamped.
Item 4. OH BOTH FORMS: 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
form.
Item 5, OH 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. OH 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
-------
I
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FOI
Generic andProduct Specific Data Call-In
incorporate that product into all your products, you
nay 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.
Item 6b. OH THE GENERIC DATA FORK: 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 Registrant's Response_Forro that
indicates how you will satisfy those requirements.
NOTE: Item 6a and 6b are not applicable for Product
specific Data.
Item 7a. OK THE PRODUCT SPECIFIC DATA FO1M; For each
manufacturing use product (MUP) for which you wish to
maintain registration, you must agree to satisfy the
data reguirements by responding "yes."
Item 7b. For each end use product (EUP) for which you wish to
maintain registration, you must agree to satisfy the
data reguirements 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 axe not applicable for Generic
Data.
-------
I
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and JPrpducrfc Specific Data Call-in
Item 8. 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.
Iten 9. ON BOTH FORMS: Enter the date of signature.
Item 10. ON BOTH FORMS: 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 on 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.
-------
F1
Page 1 of 1
United States Environmental Protection Agency
Washington, D. C. 20460
DATA CALL- III RESPONSE
INSTRUCTIONS: Please type or print in Ink. Mease reed carefully th* attached instructions and supply the Infomtlon requested
UM additional ftheet(s) if necessary.
I . Coapany IMM and Address 1. CM* f and N**a
SAMPLE COMPANY 0178 Glyphosate
1234 MAIM STREET
ANYWHERE, USA 54321_
4. EPA Product
Registration
-.
S. I with to
canc*t thla
product rofia-
tratton volun-
tartly.
8. Certification
I certify that the etateaenta Mdt on th
I acknowledge that any knowingly false i
or both tmdtr •ppUcabt* l«i.
Slpwturo and Tltl* of Coapany'a Author!
6. Centric data
A*. I M cl*i«i«g a Canairic
Data ExMption bacauta I
obtain th* actlv* lmr*dl*nt
f ram tha aourc* fM regis-
tration nuabar Hated balow.
N,A.
tfb. 1 agree to aatiafy Ceiwric
Data raquireewnta aa indicated
on th* attached fom entitled
•tequlrewenta Statue and
Regfitrant'e •eepora*.11
N.A.
(• font and alt attachment! ira true, accurate, and coaplete.
>r ailalaadlng atat«a»nt nay to punlchabl* by f Ine, laprl torment
lad Raoraaantatiya
?. Product pacific
Fom Approved
-------
fc
-------
Page l of l
United States Environmental Protection Agency
Washington, D. C. 20460
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print In Ink, Please read carefully the attached Instructions and supply the Information requested
UM additional iheet(s) If necesssry.
1, Company name and Address 2. Case f and Name
SAMPLE COMPANY 0178 Glyphosate
1234 MAIN STREET
ANYWHERE, USA 54321
4. EPA Product
•eg! strati on
-,
5. I with to
cancel this
product regis-
tration volun-
tarily.
6. Generic Data
6a. I an claiming a Generic
Data Exemption because 1
obtain the active Ingredient
from the source EPA regis-
tration nuifcer liated below.
N.A.
6b. 1 agree to satisfy Generic
Oats requirements as indicated
on the attached font entitled
"Requirements Status and
Registrant's Response,"
N.A.
i
7. Product Specific
Font Approved
ON* No. 2070-0107
2070-0057
Approval Expires 03-31-96
on this form.
I. Oite and Type of DCI
PRODUCT SPECIFIC
FEE 1 6 1994
Data
?a. My product is a HUP and
I agree to satisfy the HUP
requirements on the attached
fora entitled "Requirements
Status and Registrant's
Response, *
8. Certification
1 certify that the statements wade on this fora and all attachments are true, accurate, and complete.
! acknowledge that any knowingly fats* or Misleading statement my be punishable by fine, imprisonment
or both under applicable law.
sfpiature and Title of Company's Author ited Representative ,„..
10. Name of Company Contact
7b. My product Is an EUP and
1 agree to satisfy the EUP
requirements on the attached
fora entitled "Requirements
Status and Reglstrant'a
Response."
9. Date
11.
Phone Nunber
-------
i
-------
i
Attachment 3
Generic DCI and Product Specific DCI Requirements Status and
Registrants' Response Forms with Instructions
-------
I
-------
Instructions For Completing
The
"Requirements Status and Registrant's Response Forms"
For The Generic and product Specific Data Call-in
IMTRODPCTIOK
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 pel") 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 l 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.
-------
i
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S 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 THE GENERIC DATA FORK: 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. OH 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 (IDi) 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. OH BOTH FORMS: 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 FORMS: 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 Statusand Registrant's Response
-------
I
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 follows:
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
I* 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
KP/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
'£.
-------
i
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-in
TGAI Technical Grade Active Ingredient
TGAI/PAI Technical Grade Active Ingredient or
Pure Active Ingredient
TGAI/PAIRA Technical Grade Active Ingredient or
Pure Active Ingredient
Radiolabelled
TGAI/TEP Technical Grade Active Ingredient or
Typical End-Use Product
MET Metabolites
IMP Impurities
DEGR Degradates
* See: guideline comment
Item 8, This item completed by the Agency identifies the time
frame allowed for submission of the study or protocol
identified in item 5.
OH THE GENERIC DATA FORM: The time frame runs from the
date of your receipt of the Data Call-in notice.
OH THE PRODUCT SPECIFIC DATA FORM: 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.
Item 9. OH 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. OH BOTH FORMS: fDevelopino 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. OH BOTH FORMS: (Agreement to CostShare) I have
entered into an agreement with one or more
registrants to develop data jointly. By indicating
-------
I
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 tine, 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 FOlMSs (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 th|.s option, I
certify that this study meets all the requirements
pertaining to the conditions for submittal of
-------
i
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Spec i f ic Data Cal1-In
existing data outlined in the Data Call-in Notice
and I have attached the needed supporting
information along with this response.
Option 5. OH BOTH FORMSs (Upgrading a Study) 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. OK BOTH FORKS: fciting a Study) I am citing an
existing study that has been previously classified
by EPA as acceptable, core, core minimum, or a
study that 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.
-------
i
INSTRUCTIONS FOR COMPLETING THE "REC
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-In
STATUS AND
Option 8. fLow 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. (Recpiestfor Waiver of Data) I have read the
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.
FOR PRODUCT SPECIFIC DMA; The following option {number 7)
is a response that applies to the "Requirements Status and
Registrant's Response Form" for product specific data.
Option 7, fWaiver 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
86-5]. 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
-------
i
INSTRUCTIONS FOR COMPUTING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-in
understand that the deadline for submission of
data as specified by the original Data Call-in
notice will not change.
Item 10. OH 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.
Item 11. ON BOTH FORMS: Enter the date of signature.
Item 12. OH BOTH FORMS: Inter the name of the person EPA should
contact with questions regarding your
response.
Item 13. OH BOTH FORMS: Enter the phone number of your company
contact.
NOTE: You may provide additional information that does not
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.
-------
Page I of 1
United States Environmental Protection Agency
Washington, D.C. 20460
REQUIREMENTS STATUS AMD REGISTRANT'S RESPONSE
Form Approved
OHi Mo. 2070-0107
2070-0057
Approval Expires 03-31-96
INSTRUCTIONS: please type or print In Ink. Please read carefully the attached Instructions and supply the information requested on this form,
Use additional sheet(s) if necessary
1 . Company name and Address
4. Guideline
Requirement
Number
123-l(b)
201-1
202-1
1 ,
10. Certification
I certify that the stet
1 acknowledge that any
or both under applicabl
Signature and Title of
5, Study Title
Vegetative vigor
Droplet site spectrum
Drift field evaluation
|
2, Case f and Name
0178 Glyphosate
Chemical # and Name 103601
Isopropylamine glyphosate
Progress
Reports
1
Y
2
3
6. Use
Pattern
ABCD1PJK
ABCbfcJ
ABCDEJ
7. Test
Substance
TGAI
tip
TCP
ements made on this form and all attachments are true, accurate, and complete.
knowingly false or misleading statement may be punishable by fine, imprisonment
e taw.
Company's Authorized Representative
12. Name of Company Contact
3. Date and Type of DC!
GENERIC
FEB I 6 1994
B. Time
Frame
12
12
24
11.
13.
mos.
mos .
mos.
9. Registrant
Response
Date
Phone Nuifcer
-------
i
-------
Page 1 of 3
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in Ink. Please read carefully the attached instructions and supply the information requested
Use additional sheet(s) if necessary.
1. Company name and Address 2, Case 0 and Name
SAMPLE COMPANY 0178 Glyphosate
1234 MAIN STREET
ANYWHERE, USA 54321 EPA Reg. No. 70-269
4, Guideline
Requi rement
Number
• . ' '. :',• %1 , •',' . ,'<,,',•'<', . ,< •
isi-i
6!«2([a| - ,"-f •
61-2(b)
62-1
62-2 ••"•: . : '.
-62-3
63-3
63-5
63-6
63-7
63-8
63-9
5. Study Title
Prod Chf* - Regular Chemical
Product Identity & composition (1)
Oeacriptn starting mateclat*, (1,2)
productn ft fomtlatn
Discuss loo of formation of (1,3)
Preliminary analysli (1,4)
Certlf »ci»tlon of limits (1^S»
Analytical method CD
Physical iiate '. '•• ":'..'• ': •'• '
Melting point (6)
Boiling point •''. .-- -:<-.::::::lv:
-------
Page 2 of 3
United States Environmental Protection Agency
Washington, D* C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully
Use additional sheet(s) if necessary.
t. Company name and Address
SAMPLE COMPANY
1234 MAIN STREET
ANYWHERE, USA 54321
4. Guideline
Requirement
Kuiiber
63-10
63-11
63-12
63-13
63-14
63-15
63-16
y63-17
»3-18
TW3-19
163-20
63-21
si-i
81-2
81-3
81*4
81-5
5. Study title
Dissociation constant
Octanol/vater partition (8)
coefficient
pH (9)
Stability
Oxidizing or reducing action (10)
MtMiMbfUty (11)
Explodabtlity (12)
Storage stability
Viscosity (13)
MIscibiUty (14)
Corrosion characteristics
Dielectric breakdown voltage <15)
Acute fo*f$ - Reuular Ow»!cat
the attached instructions and supply the
2. Case * and Name
0178 Glyphosate
EPA Reg. No. 70-269
Acute oral toxiCity-fat (1,34,37)
Acute dermal (1,2,37}
toxfctty-rafcfatt/Nit
Acute Inhalation toxlctty-rat (3)
Primary eye Irritation-rabbit (Z)
Primary dermal Irritation (1,1)
Initial to indicate certification as to Information on this page
(full text of certification is on page one).
Progress
Reports
1
2
3
6. Use
Pattern
information requested
ABCDEFGHlJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHtJKlMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKtHNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKIMNO
ABCDEFGHIJKUtNO
ABCDEFGHIJKOmo
ABCDEFGttlJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGH1JKLMNO
ABCDEFGHIJKLMNO
7, Test
Form Approved
fMJD U.K ^mfl A4A7
OMB NO. 2070*0107
2070-0057
Approval Expires 03-31-96
on this form.
3. Date and Type of DCI
PRODUCT SPECIFIC
ID# 70-RD-3263
FEB I 6 I994
Substance
TGAl/PAt
PAI
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
and TGAI
and TGAI
and TGAI
and TGAI
8. Time
Frame
8 JTtOS.
8 mos.
8 mos.
B mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
9. Registrant
Response
Date
-------
Page 3 of 3
United States Environmental Protection Agency
Washington, D. c. 20460
REQUIREMENTS STATUS AND -REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink, Please read carefully
Use additional sheet(s) If necessary,
1. Company name and Address
SAMPLE COMPANY
1234 MAIN STREET
ANYWHERE, USA 54321
4. Guideline
Requirement
Number
8 l*6f:f f;:y-- :••••* :
5, Study Title
the attached Instructions and supply the
Information requested
2. Case f and Name
0178 Glyphosate
EPA Reg. No. 70-269
Dermal jJensitfiiilbfi •;•.-. •• {<) .'';:', -^ "
I
Progress
Reports
1
2
3
6. Use
Pattern
ABCDEFGf
Initial to indicate certification as to Information on this page
(full text of certification Is on page one).
Form Approved
OM8 No. 2070-0107
2070-0057
Approval Expires 03-31-96
on this form.
3. Date and Type of DCI
PRODUCT SPECIFIC
ID# 70-RD-3263
FEB 1 6 1994
7. Test
Substance
ttP/EP
8. Time
frame
8 ifids.
9. Registrant
Response
• ::-.::i':-:>';::"r'.-:V:>'>:
- .-• -,-.': .:";::-,r>.::""::::::';V<;
Date
-------
i
-------
Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEPUTATIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0178 Glyphosate
Key: HP * manufacturing-use product; EP * end-use product; provided formulators purchase their active ingredient(s) from a registered source, they need not submit or cite
data pertaining to the purchased product.(NOTE: If a product Is a 100 percent repackage of another registered product that is purchased, and any use for the product does
not differ from those of the purchased and registered source, users are not subject to any data requirements Identified in the tables.]; TEP = typical end-use product;
TGAI » technical grade of the active ingredient; PA! * "pore" active ingredient; PAIRA * "pure" active ingredient, radfoiabeled.
Use Categoric* Key:
C - Terrestrial nonfood crop
H * Greenhouse food crop
H - Indoor nonfood.
A - Terrestrial food crop
F - Aquatic nonfood Industrial
K - Residential outdoor
B - Terrestrial food feed crop
G « Aquatic nonfood residential
L - Indoor food
D * Aquatic food crop
I - Greenhouse nonfood crop
N - Indoor Medical
i * Aquatic nonfood outdoor
J - Forestry
0 - Indoor residential
Footnotes: IThe following notes are referenced fn column two (5. Study Tft(e) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
prod die* - Regular chemical
1 Requirements pertaining to product Identity, composition, analysis, and certification of ingredients are detailed further in the following sections: MSB.155 for
product identity and composition {61-1}; *15fl.16Q, 158.162, and 1S8.I65 for description of starting materials and manufacturing process (61-2); '158.167 for
discussion of formation of impurities (61-3); *158.170 for preliminary analysis (62-1); *158.175 for certification of Units (62-2); and *158.180 for enforcement
analytical methods (62-3).
2 A schematic diagram and/or brief description of the production process Mill suffice if the pesticide is not already under full scale production and an experimental
use permit is being sought.
3 If the pesticide Is not already under full scale production and an experimental use permit is sought, a discussion of unintentional ingredients shall be submitted to
the extent this information is available.
4 To support registration of an HP or EP, whether produced by an integrated system or not, the technical grade of Active Ingredient must be analyzed. If the technical
grade of Active Ingredient cannot be isolated, a statement of composition of the practical equivalent of the technical grade of Active Ingredient must be submitted.
Data on EPS or MPs Milt be required on a case-by-case basis.
5 Certified limits are not required for Inert ingredients in products proposed for experimental use.
6 Required if technical chemical is solid at room temperature.
•7 Required if technical chemical is liquid at room temperature.
8 Required (f technical chemical is organic and non-polar.
9 Required if test substances are dispersfble with water.
10 Required if product contains an oxidizing or reducing agent.
11 Required if product contains combustible liquids.
12 Required if product is potentially explosive.
13 Required ff product is a liquid.
14 Required if product is an emulsffiable liquid and is to be diluted with petroleum solvents.
15 Required if end-use product is liquid and is to be used around electrical equipment.
Acute Toxic - Regular Cheancal
1 Not required if test material is a gas or highly volatile.
2 Mot required if test material is corrosive to skin or has pH less than 2 or greater than 11.5; such a product Mill be classified as Toxieity Category I on the basis
of potential eye and dermal irritation effects.
-------
Page 2 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case # and Name; 0178 Glyphosate
Footnotes (cont.):
s
4
36
Required if the product consists of, or under conditions of use will result in, an Inflatable material (e. g., gas, volatile substances, or aerosol/paniculate).
Required unless repeated dermal exposure does not occur under conditions of use,
Special testing (acute, subchronic, and/or chronic) is required for organophospates, and may be required for other cholfnesterase inhibitors and other pesticides
which have demonstrated a potential to adversely affect the visual system. Registrants should consult with the agency for development of protocols and methodology
prior to initiation of studies,
Testing of the IP dilution is required If It can be reasonably anticipated that the results of such testing may meet the criteria for restriction to use by certified
applicators specified In 40 CFR t5Z.170(b) or the criteria for initiation of special review specified in 40 CFR 154.7 (1>.
-------
Attachment 4
EPA Grouping of End Use Products for meeting Acute Toxicology Data
Requirements
-c.
-------
-------
EPA'fi BATCHING OF GLYPHOSATE PRODUCTS FOR KEETING ACUTE TOXICITY
DATA REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the tine, 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 similar11 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
form, "Data call-in Response,11 asks whether the registrant will
meet the data requirements for each product. The second form,
"Requirements Status and Registrant's Response," lists the
-------
i
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.
-------
i
T«bie 1
Mtcfe
t
2
3
4
5
EPA teg. No.
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
19713-364
I Gty|*
-------
Table II lists products that were either considered not to be similar or the Agency lacked
sufficient information for decision Baking and Mere not placed in any batch. Registrants of these products
•re responsible for meeting the acute toxicity data requirements separately for each product.
Table 2 (Ho batch)
'•!F&m:W&fay$>f
239-2469
239-2509
Z39-2516
239-2596
524-308
524-326
524-332
524-333
524-341
524-370
524-376
524-382
524-390
524-420
524-421
524-431
524-439
524-440
524-445
S24-449
524-450
524-451
524-452
524-432
7401-405
935-48
10370-213
10583-15
?i^6:"rV>riulat Ion ''TypeV ' ; •'•
Liq
Liq
Lit|
Aerosol
Liq
Lfq
Solid
Liq
Liq
Liq
Liq
Liq
Liq
Solid
Solid
Capsular
Liq
Liq
Liq
Liq
Liq
Liq
Solid
Liq
Liq
Liq^
Lfq
Liq
-------
i
Attachment 5
EPA Acceptance Criteria
-------
i
-------
i
SUBDIVISION D
Guideline Study Title
Series 61 Product Identity and Composition
Series 62 Analysis and Certification of Product Ingredients
Series 63 Physical and Chemical Characteristics
-------
e
-------
til 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
intentionally-added men ingredient.
3. Name 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
_ 0.1% or was found at >_ 0.1% by product analyses and (2) certain
lexicologically significant impurities (see 13).
-------
i
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 _>_ 0.1 %.
2. Degree of accountability or closure > ca 98%.
3. Analyses conducted for certain trace toxic impurities at lower than 0.1 % (examples, nitrosamines in the
case of products containing dmitroanilines or containing secondary or tertiary amines/alkanolamines plus
nitrites; polyhalogenated dibenzodioxins and dibcnzofurans). [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.
-------
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 in "C
Any observed decomposition reported
63-6 Boiling 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 in lbs/ft3
or Ibs/gallon.J
63-8 Solubility
Determined in distilled water and representative polar and non-polar solvents, including those used in
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 in mm Hg (torr) or other conventional units
63-10 Dissociation Constant
Experimental method described
Temperature of measurement specified (preferably about
20-25 °C)
-------
Erf
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
63-13 Stability
Sensitivity to metal ions and metal determined
Stability at normal and elevated temperatures
Sensitivity to sunlight determined
-------
i
SUBDIVISION F
Guideline Study Title
81-1 Acute Oral Toxicity in the Rat
81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea
Pig
81-3 Acute Inhalation Toxicity in the Rat
81-4 Primary Eye Irritation in the Rabbit
81-5 Primary Dermal Irritation Study
81-6 Dermal Sensitization in the Guinea Pig
-------
-------
i
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.
5, 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 all 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 no! be required for every study.
-------
i
SI-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 pn, rabbits 2.0-3.0 kg or guinea pigs 350-150 gm.
4. Dosing, single dermal.
5. Dosing duration at least 24 hours.
6.* Vehicle control, only if toxicity of vehicle is unknown,
7. Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/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
ingest ion.
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 narked wich an * are supplemental and may not be required for every study.
-------
I
81-3 Acute Inhalation Toxicitj in the Eat
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 toxicity and expected use
or contains panicles of inhalable size for man (aerodynamic diameter 15 ftm 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,
6. Chamber temperature, 22° C (±2"), relative humidity 40-60%.
7. Monitor rate of air flow.
8. Monitor actual concentrations of test material in breathing zone,
9. Monitor aerodynamic particle size for'aerosols.
10. Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of
respirable substance).
! 1. 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.
-------
i
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 j<2 or >11.5.
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 1, 24, 48 and 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.
-------
i
81-5 Primary Dermal Irritation Study
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 or has a pH of ,<2 or .>.! 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.
7. 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 application 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.
-------
i
81-6 Dermal Sensitization in the Guinea Pig
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 or has a
pHof <2or.>n.5.
3. One of the following methods is utilized:
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
Buehler test
Open epieutaneous test
Mauer optimization test
Footpad technique in guinea pig.
4. Complete description of test,
5.* 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
-------
i
-------
List of All Registrants Sent This Data Call-in Notice
Case f and Name
0178 Glyphosate
Chemical # and Name
103601 Isopropylamine glyphosate ( N-(phosphonomethyl)gly
Company Mutnber Company Name
Additional Name
Address
City ft State
000070
000239
000524
000935
007401
010370
010583
019713
034911
046515
056644
066459
UHBUR-ELLIS COMPANY
CHEVRON CHEMICAL CO
MONSANTO CO
OCCIDENTAL CHEMICAL CORPORATION
VOLUNTARY PURCHASING GROUP, INC.
ROUSSEL UCLAF CORP
LUNDAL ASSOCIATES INC
OREXEL CHEMICAL CO
MI-YIELD CHEMICAL COMPANY
CELEX CORPORATION
SECURITY PRODUCTS COMPANY Of DELAW
KAUAI TARO GROWERS ASSOCIATION
ORTHO CONSUMER PRODUCTS DIVISION
AGENT FOR: MONSANTO AGRICULTURAL C
BOX 16458
940 HENSLEY ST
700 14TH ST, N.U. SUITE 1100
DEVELOPMENT CENTER, V-81 iOX 344
P. 0. BOX 460
95 CHESTNUT RIDGE RD
7493 E TIMBERLANE COURT.
BOX 9306
BOX 460
377 AMELIA ST,
BOX 59084
BOX 427
FRESNO CA
RICHMOND CA
WASHINGTON DC
NIAGARA FALLS NY
BOMHAM TX
MONTVAIE NJ
SCOTTSDALE AZ
MEMPHIS TN
BONHAM TX
PLYMOUTH Ml
MINNEAPOLIS MN
HANALE I HI
93755
94804
20005
14302
75418
07645
85258
38109
75418
48170
55459
96714
-------
f
-------
Attachment 7
Cost Share/Data Compensation Forms
•J***tZ:'
•C3T"
-------
I
-------
I
&EPA
United States Environmental
Washington, DC
CERTIFICATION WITH
DATA COMPENSATION
Protection Agency
20468
RESPECT TO
REQUIREMENTS
OU1 M*. 2070-0107
8070-0057
Appravtl Elplrm »-ll-f
Public reporting burden for this collection of information it estimated to average 15 minutes per response, Including
time lor 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 suggestions for reducing this burden, to Chief, Information Policy
iranch. PM-223, US. Environmental Protection Agency. 401 M St.. S.W.. Washington, DC 204SO; and to the Office
of Management and Budget. Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Piaase fill In blanks below.
Company MUM
ChWBlC*! M«M
Company Number
EPA CJmnie*! Ntm»k*r
I Certify that:
1. For each study cited in support of registration or rtregistraf ton under the Federal Insecticide, Fungicide and
Rodentitide Act (F1FRA) mat is an exclusive use study. 1 am the original data submitter, or I have obtained the
written permission of the original data submitter to ette that study.
2. That lor each study cited in support of registration or reregistratton under FlFRA that is NOT an exclusive use
study, l am the original data submitter, or i have obtained the written permission of the original data submitter, or i
have notified in writing the companypes) that submitted data I have cited and have offered to: (a) Pay
compensation for those data in accordance with sections 3(c)(i )(D) and 3(c)(2)(D) of FlFRA; and (b) Commence
negotiation to determine which data are subject to the compensation requirement of FlFRA and the amount of
compensation due, I any. The companies I have notHied are: {check one)
I} AB companies on the data submitters' fist tor the active ingredient fisted on this form (de-All
Method or Cne-AB option under the Selective Method). (Also sign the General Offer to Pay
below.)
[} The companies who have submitted the studies fsted on the back of this form or attached
sheets, or indicated on the attached "Requirements Status and Registrants' Response Form.*
3. That i have previously complied wfifi section 3
-------
i
-------
f/EPA
United States Environmental Protection Agency
Washington, DC 20460 j
CERTIFICATION OF OFFER TO COST !
SHARE !N THE DEVELOPMENT OF DATA
Ollt M«, 1070-0107
SQ70-0057
Approval |*»|»*«
Public reporting burden tor this ooBection of information is estimated to average 15 minutes per response, including
time tor 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 suggestions tor reducing this burden, to Chief, Information Polcy
Branch, PM-223, U.S, Environmental Protection Agency, 401 M St. S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Pleaae fill In blanks betow.
Company N*n*
Cfeamleal Nam*
EM diw»I«l MvMlMr
I Certify that:
My company is wilting to devetp and submit the data required by EPA tinder the authority of the Federal
Insecticide, Fungicide and Rodentfcide Act (RFRA), If necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop Jointly or share hi the cost of developing
My firm has offered in wilting to enter into such an agreement. That offer was Irrevocable and included an
offer to be bound by arbitration decision under section 3{c)(2)(B)(fii) of RFFtA rf final agreement on an
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
•f Fkm(»)
OBI* *f Oftor
Certification:
I cerWythat I am duly authorized to represent the cxm^w^Rarne above, arid that the staternents that I have made on
this form and all attachments therein are true, accurate, and complete, i acknowledge that any knowingly false or
misleading statement may be punishable by fine or Imprisonment or both under applicable taw.
Signature ml Company'* Authorised ftaptaaafttaliva
Data
Item end Till* (Ptoa** Typ* or Print)
EPA F*f* Sf7»*2 (Ml) fUpiaoo. EPA Font SiSO-t, «Meh to
-------
i
------- |