Proposed Re-evaluation Decision

PRVD2015-01

Glyphosate

13 April 2015

(publié aussi en français)

This document is published by the Health Canada Pest Management Regulatory Agency. For further
information, please contact:
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Health Canada
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 ISSN:

1925-0959 (print)
1925-0967 (online)

Catalogue number:

H113-27/2015-1E (print)
H113-27/2015-1E-PDF (PDF version)

© Her Majesty the Queen in Right of Canada, represented by the Minister of Health Canada, 2015
All rights reserved. No part of this information (publication or product) may be reproduced or transmitted in any form or by any
means, electronic, mechanical, photocopying, recording or otherwise, or stored in a retrieval system, without prior written
permission of the Minister of Public Works and Government Services Canada, Ottawa, Ontario K1A 0S5.

 Table of Contents
Overview ......................................................................................................................................... 1
What Is the Proposed Re-evaluation Decision? .......................................................................... 1
What Does Health Canada Consider When Making a Re-evaluation Decision? ........................ 1
What Is Glyphosate? .................................................................................................................... 2
Health Considerations.................................................................................................................. 2
Proposed Measures to Minimize Risk ......................................................................................... 7
What Additional Scientific Information is Being Requested? .................................................... 7
Next Steps ................................................................................................................................. 8
Science Evaluation .......................................................................................................................... 9
1.0
Introduction ............................................................................................................. 9
2.0
The Technical Grade Active Ingredient, Its Properties and Uses............................ 9
2.1
Identity of the Technical Grade Active Ingredient .................................................. 9
2.2
Physical and Chemical Properties of the Technical Grade Active Ingredient ...... 10
2.3
Polyethoxylated Tallow Amines ........................................................................... 10
2.4
Description of Registered Glyphosate Uses .......................................................... 10
3.0
Impact on Human and Animal Health ................................................................... 11
3.1
Toxicology Summary ............................................................................................ 11
3.2
Dietary Exposure and Risk Assessment ................................................................ 17
3.2.1 Determination of Acute Reference Dose .................................................................. 18
3.2.2 Acute Dietary Exposure and Risk Assessment ......................................................... 19
3.2.3 Determination of Acceptable Daily Intake ............................................................... 20
3.2.4 Chronic Dietary Exposure and Risk Assessment...................................................... 20
3.3
Exposure from Drinking Water ............................................................................. 21
3.3.1 Concentrations in Drinking Water ............................................................................ 21
3.3.2 Drinking Water Exposure and Risk Assessment ...................................................... 21
3.4
Occupational and Non-Occupational Exposure and Risk Assessment ................. 21
3.4.1 Toxicology Endpoint Selection for Occupational and Non-Occupational Risk
Assessment ................................................................................................................ 22
3.4.2 Occupational Exposure and Risk Assessment .......................................................... 22
3.4.3 Non-Occupational Exposure and Risk Assessment .................................................. 25
3.5
Aggregate Exposure and Risk Assessment ........................................................... 27
3.5.1 Toxicology Endpoint Selection for Aggregate Risk Assessment ............................. 27
3.5.2 Residential and Non-Occupational Aggregate Exposure and Risk Assessment ...... 28
3.6
Polyethoxylated Tallow Amines ........................................................................... 29
3.7
Incident Reports Related to Human Health ........................................................... 29
4.0
Impact on the Environment ................................................................................... 30
4.1
Fate and Behaviour in the Environment ................................................................ 30
4.2
Environmental Risk Characterization .................................................................... 31
4.2.1 Risks to Terrestrial Organisms.................................................................................. 33
4.2.2 Risks to Aquatic Organisms...................................................................................... 38
4.2.3 Incident Reports Related to the Environment ........................................................... 40

Proposed Re-evaluation Decision – PRVD2015-01

 5.0
5.1
5.2
5.3
6.0
6.1
6.2
7.0

Value ...................................................................................................................... 41
Value of Glyphosate .............................................................................................. 41
Commercial Class Products ................................................................................... 43
Domestic Class Products ....................................................................................... 43
Pest Control Product Policy Considerations .......................................................... 44
Toxic Substances Management Policy Considerations ......................................... 44
Formulants and Contaminants of Health or Environmental Concern ................... 46
Organisation for Economic Co-operation and Development Status of
Glyphosate ............................................................................................................. 46
8.0
Summary................................................................................................................ 47
8.1
Human Health and Safety ...................................................................................... 47
8.1.1 Dietary Risk .............................................................................................................. 47
8.1.2 Non-Occupational Risk............................................................................................. 47
8.1.3 Occupational Risk ..................................................................................................... 47
8.1.4 Aggregate Risk.......................................................................................................... 47
8.1.5 Polyethoxylated Tallow Amines ............................................................................... 48
8.2
Environmental Risk ............................................................................................... 48
8.3
Value ...................................................................................................................... 48
9.0
Proposed Re-evaluation Decision .......................................................................... 49
9.1
Proposed Regulatory Actions ................................................................................ 49
9.1.1 Proposed Regulatory Action Related to Human Health ........................................... 49
9.1.2 Proposed Regulatory Action Related to the Environment ........................................ 50
9.1.3 Other Label Amendments ......................................................................................... 50
9.2
Additional Data Requirements .............................................................................. 51
List of Abbreviations .................................................................................................................... 53
Appendix I Products Containing Glyphosate that are Registered in Canada Excluding
Discontinued Products or Products with a Submission for Discontinuation as of 3
May 2012, Based Upon the PMRA’s Electronic Pesticide Regulatory System (ePRS) Database1 ...................................................................................................... 57
Appendix IIa Registered Commercial Class Uses of Glyphosate in Canada as of 3 May 2012.
Uses From Discontinued Products or Products With a Submission for
Discontinuation are Excluded1 .............................................................................. 63
Appendix IIb Registered Domestic Class Uses of Glyphosate in Canada as of 23 October 2012.
Uses from Discontinued Products or Products with a Submission for
Discontinuation are Excluded.1 ............................................................................. 69
Appendix III Toxicity Profile and Endpoints for Health Risk Assessment ............................. 71
Table III.1ASummary of Toxicology Studies for Glyphosate Acid ......................................... 71
Table III.1B Summary of Toxicology Studies for AMPA ......................................................... 88
Table III.2 Toxicological Points of Departure for Use in Human Health Risk Assessment for
Glyphosate Acid, AMPA, N-acetyl glyphosate and N-acetyl AMPA .................. 91
Appendix IV Dietary Exposure and Risk Estimates for Glyphosate ....................................... 93
Table IV.1 Dietary Exposure and Risk Estimates for Glyphosate........................................... 93

Proposed Re-evaluation Decision – PRVD2015-01

 Appendix V
Food Residue Chemistry Summary ................................................................... 95
Table V.1 Residue Definitions ............................................................................................... 97
Appendix VI Supplemental Maximum Residue Limit Information, International Situation and
Trade Implications ............................................................................................... 101
Table VI.1 Canadian Maximum Residue Limits ................................................................... 101
Table VI.2 Canadian Maximum Residue Limits and International Tolerances / Maximum
Residue Limits for Glyphosate ............................................................................ 104
Table VI.3 Comparison of Residue Definitions derived by Canada, United States,
JMPR/Codex and European Union...................................................................... 110
Appendix VII Agricultural Mixer/Loader/Applicator and Postapplication Risk Assessment 111
Table VII.1 Commercial Mixer/Loader/Applicator Exposure and Risk Assessment ............. 111
Table VII.2 Mixer/Loader Tree Injection Exposure and Risk Assessment ............................ 111
Table VII.3 Commercial Postapplication Exposure and Risk Assessment ............................. 112
Appendix VIII Non-Occupational Risk Assessment .............................................................. 117
Table VIII.1Adult Short-Term Residential Applicator Exposure ........................................... 117
Table VIII.2Adult, Youth and Children Short-term Postapplication Exposure and Risk
Assessments on Lawns and Turf ......................................................................... 118
Table VIII.3Adult, Youth and Children Short-term Postapplication Exposure and Risk
Assessments on Golf Course Turf ....................................................................... 118
Table VIII.4Incidental Oral Exposure Estimates and MOEs for Hand-to-Mouth Transfer to
Children ............................................................................................................... 119
Table VIII.5Incidental Oral Exposure Estimate and MOE for Object-to-Mouth Transfer to
Children ............................................................................................................... 119
Table VIII.6Bystander Exposure and Risk Assessment .......................................................... 119
Appendix IX Aggregate Risk Assessment ............................................................................. 121
Table IX.1 Aggregate Risk Assessment ................................................................................ 121
Appendix X
Environmental Fate, Toxicity and Risk Assessment of Glyphosate ................ 123
Table X.1 Fate and Behaviour of Glyphosate, Its Transformation Product AMPA and the
Formulant POEA in the Terrestrial Environment................................................ 123
Table X.2 Fate and Behaviour of Glyphosate, its Transformation Product AMPA and the
Formulant POEA in the Aquatic Environment.................................................... 133
Table X.3 Estimated Environmental Concentrations Based on Crop and Maximum
Application Rates of Canadian Registered Products Containing Glyphosate ..... 136
Table X.4 Maximum Estimated Environmental Concentrations in Vegetation and Insects
after Direct Coarse Droplet Applications of Glyphosate at Maximum Rates on
Apples (2 × 4320 g ae/ha + 1 × 3960 g ae/ha at 14-day Intervals and a 14.4 day
Foliar DT50) ......................................................................................................... 137
Table X.5 Refined Estimated Environmental Concentrations in Vegetation and Insects after
Direct Coarse Droplet Applications of Glyphosate at Maximum Rates on Apples
(2 × 4320 g ae/ha + 1 × 3960 g ae/ha at 14-day Intervals, 14.4 day Foliar DT50 and
3% drift) ............................................................................................................... 137
Table X.6 The Estimated Environmental Concentration of Glyphosate in Water (mg a.e./L)
at 15 and 80 cm Depth as a Result of Direct Application from Uses on Various
Crops .................................................................................................................... 138

Proposed Re-evaluation Decision – PRVD2015-01

 Table X.7

Table X.8

Table X.9
Table X.10
Table X.11
Table X.12
Table X.13
Table X.14
Table X.15

Table X.16

Table X.17

Table X.18

Table X.19

Table X.20
Table X.21
Table X.22
Table X.23
Table X.24
Table X.25
Table X.26

Refined Estimated Environmental Concentration of Glyphosate in Water (mg
a.e./L) at 15 and 80 cm Depth as a Result of Direct Application from Uses on
Various Crops ...................................................................................................... 138
Toxicity Values of Glyphosate Technical, Glyphosate Formulations and the
Transformation Product AMPA to Earthworms and the Collembolan Folsomia
candida ................................................................................................................ 139
Toxicity Values of Glyphosate Technical and its Formulations to Honeybees .. 141
Toxicity Values of Glyphosate Technical and its Formulations to Beneficial
Insects .................................................................................................................. 143
Toxicity Values of Glyphosate Technical and its Formulations to Birds............ 144
Toxicity Values of Glyphosate Technical and its Formulations to Mammals .... 148
Toxicity Values of Glyphosate Technical and its Formulations to Terrestrial Plant
– Seedling Emergence ......................................................................................... 151
Toxicity Values of Glyphosate Technical and its Formulations to Terrestrial Plant
– Vegetative Vigour............................................................................................. 153
Effects of Single Exposure to a Glyphosate Formulation (Roundup Herbicide) on
Two-Year-Old Green Ash, Fraxinus subintegerrima, Under Field Conditions
(PMRA 1883054) ................................................................................................ 163
Toxicity Effects of Glyphosate Technical, Glyphosate Formulations, the
Transformation Products AMPA and the Formulant POEA to Aquatic Organisms
............................................................................................................................. 163
Summary of Species Sensitivity Distributions (SSDs) for Glyphosate, Its Major
Tramsformation Product AMPA and the Formulant POEA: HC5 OR Most
Sensitive Species by Taxonomic Group: Fish, Aquatic Invertebrates, Amphibians,
AquaticPlants, Algae and Terrestrial Plants ........................................................ 201
Risk Quotients for Earthworms and the Soil Benefecials Exposed to the
Glyphosate Technical, Glyphosate Formulations and the Transformation Product
AMPA.................................................................................................................. 202
Screening and Refinement Level Risk Assessment and Risk Quotients for Bees
and Predators and Parasitic Arthropods Exposed to the Glyphosate Technical,
Glyphosate Formulations and the Transformation Product AMPA .................... 204
Screening Level Risk Assessment for Birds and Mammals Exposed to Glyphosate
Technical ............................................................................................................. 208
Risk Assessment Refinement for Birds Exposed to Glyphosate Technical ........ 210
Screening Level Risk Assessment for Glyphosate Formulations Exposed to Wild
Birds and Mammals – Single Application Rate .................................................. 212
Further Characterization of Risks of Glyphosate Formulations to Wild Birds –
Single Application Rate ....................................................................................... 213
Further Characterization of the Risk of Glyphosate Technical to Wild Mammals
............................................................................................................................. 214
Further Characterization of Risks of Glyphosate Formulations to Wild Mammals –
Single Application Rate ....................................................................................... 216
Risk Assessment (In-field and Off-field) and Risk Quotients for Terrestrial
Vascular Plants (Seedling Emergence and Vegetative Vigour) at the Maximum
Rate of Application for Glyphosate in Different Crop Productions .................... 218

Proposed Re-evaluation Decision – PRVD2015-01

 Table X.27 Screening Level Risk Assessment of Glyphosate Technical, Glyphoate
Formulations, the Transformation Product AMPA and the Formulant POEA to
Aquatic Organisms Following Ground Boom Application in Different Crop
Productions .......................................................................................................... 219
Table X.28 Further Risk Characterization of Glyphosate Technical, Glyphosate Formulations,
Transformation Product AMPA and the Formulant POEA Exposed to Aquatic
Organisms Following Drift from Ground Boom or Aerial Applications in
Different Crop Productions ................................................................................. 224
Table X.29 Further Risk Characterization of Glyphosate Technical and Glyphosate
Formulations Exposed to Aquatic Organisms Following Runoff in Different Crop
Productions .......................................................................................................... 226
Table X.30 Further Risk Characterization of Glyphosate Technical, Glyphosate Formulations,
Transformation Product AMPA and the Formulant POEA Exposed to Aquatic
Organisms Using Freshwater Monitoring Data in Different Crop Productions .. 227
Appendix XI Glyphosate Aquatic Ecoscenario and Drinking Water Assessment................. 229
Table XI.1 Major Groundwater and Surface Water Model Inputs for Level 1 Assessment of
Glyphosate and AMPA (Combined Residues) .................................................... 230
Table XI.2 Crops, Rates Modelled at Level 1 Ecoscenario Modelling ................................. 231
Table XI.3 Level 1 Aquatic Ecoscenario Modelling EECs (µg a.e./L) in Water Column for
Glyphosate in a Water Body 0.8 m Deep, Excluding Spray Drift....................... 231
Table XI.4 Level 1 Aquatic Ecoscenario Modelling EECs (µg a.e./L) in Water Column for
Glyphosate in a Water Body 0.15 m Deep, Excluding Spray Drift..................... 232
Table XI.5 Level 1 Aquatic Ecoscenario Modelling EECs (µg a.e./L) in Pore Water for
Glyphosate in a Water Body 0.8 m Deep, Excluding Spray Drift....................... 232
Table XI.6 Level 1 Estimated Environmental Concentrations of the Combined Residue
(Glyphosate and AMPA) in Potential Drinking Water ....................................... 233
Table XI.7 Level 2 Estimated Environmental Concentrations of the Combined Residue
(Glyphosate and AMPA) in Potential Drinking Water ....................................... 234
Appendix XII Proposed Label Amendments for Products Containing Glyphosate ................ 237
Table 1
Buffer Zones for the Protection of Aquatic Organisms and Terrestrial Plants from
Spray Drift of Glyphosate Products Formulated with POEA.............................. 240
Table 2.
Buffer Zones for the Protection of Aquatic Organisms and Terrestrial Plants from
Spray Drift of Glyphosate Products without POEA ............................................ 246
References ................................................................................................................................... 250

Proposed Re-evaluation Decision – PRVD2015-01

 Overview
What Is the Proposed Re-evaluation Decision?
After a re-evaluation of the herbicide glyphosate, Health Canada’s Pest Management Regulatory
Agency (PMRA), under the authority of the Pest Control Products Act and Regulations, is
proposing continued registration of products containing glyphosate for sale and use in Canada.
An evaluation of available scientific information found that products containing glyphosate do
not present unacceptable risks to human health or the environment when used according to
the proposed label directions. As a condition of the continued registration of glyphosate uses,
new risk reduction measures are proposed for the end-use products registered in Canada. No
additional data are being requested at this time.
This proposal affects the products containing glyphosate registered in Canada. Once the final
re-evaluation decision is made, the registrant will be instructed on how to address any new
requirements.
This Proposed Re-evaluation Decision is a consultation document 1 that summarizes the science
evaluation for glyphosate and presents the reasons for the proposed re-evaluation decision. It
also proposes new risk reduction measures to further protect human health and the environment.
The information is presented in two parts. The Overview describes the regulatory process
and key points of the evaluation, while the Science Evaluation provides detailed technical
information on the assessment of glyphosate.
The PMRA will accept written comments on this proposal up to 60 days from the date of
publication of this document. Please forward all comments to Publications (please see contact
information indicated on the cover page of this document).

What Does Health Canada Consider When Making a Re-evaluation Decision?
Health Canada’s pesticide re-evaluation program considers potential risks as well as the value
of pesticide products to ensure they meet modern standards established to protect human health
and the environment. Re-evaluation draws on data from registrants, published scientific reports,
information from other regulatory agencies and any other relevant information.
In 2010, Health Canada published a re-evaluation work plan for glyphosate (REV2010-02)
outlining the focus of this re-evaluation and indicating that the PMRA is working cooperatively
with the United States Environmental Protection Agency on the re-evaluation of glyphosate.
As part of this re-evaluation, the effect of Polyethoxylated Tallow Amines (POEA) and the
metabolite and transformation product Aminomethylphosphonic acid (AMPA) are also included.
1

“Consultation statement” as required by subsection 28(2) of the Pest Control Products Act.

Proposed Re-evaluation Decision – PRVD2015-01
Page 1

 For more details on the information presented in this overview, please refer to the Science
Evaluation section of this consultation document.

What Is Glyphosate?
Glyphosate is a non-selective herbicide registered for post-emergence control of a wide spectrum
of weeds including annual and perennial broadleaf and grassy weeds, weedy trees and brush. It is
registered under various forms including glyphosate acid, glyphosate isopropylamine or
ethanolamine salt, glyphosate mono-ammonium or diammonium salt, glyphosate potassium salt
and glyphosate dimethylamine salt. Another form, glyphosate trimethylsulfonium salt, was
voluntarily discontinued by the registrant and therefore is not included in the current reevaluation.
Glyphosate is registered for use on the following Use-Site Categories (USC): Forests and
Woodlots, Industrial Oil Seed Crops and Fibre Crops, Terrestrial Feed Crops, Terrestrial Food
Crops, Industrial and Domestic Vegetation Control Non-food Sites, Ornamentals Outdoors and
Turf.
Glyphosate products are formulated as solutions, pastes or tablets and can be applied using
ground or aerial equipment. Some special application techniques are also used.

Health Considerations
Can Approved Uses of Glyphosate Affect Human Health?
Products containing glyphosate acid are unlikely to affect your health when used according
to label directions.
Potential exposure to glyphosate may occur through the diet (food and water), when handling
and applying the products containing glyphosate, or by entering treated sites. When assessing
health risks, two key factors are considered: the levels at which no health effects occur in animal
testing and the levels to which people may be exposed. The dose levels used to assess risks are
established to protect the most sensitive human population (for example, children and nursing
mothers). Only uses for which exposure is well below levels that cause no effects in animal
testing are considered acceptable for registration.
Toxicology studies in laboratory animals describe potential health effects from varying levels of
exposure to a chemical and identify the dose at which no effects are observed. The health effects
noted in animals occur at doses more than 100 times higher (and often much higher) than levels
to which humans are normally exposed when glyphosate products are used according to label
directions.
In laboratory animals, glyphosate was of low acute oral, dermal and inhalation toxicity.
Glyphosate did not cause skin irritation or an allergic skin reaction. It was severely irritating to
the eyes.

Proposed Re-evaluation Decision – PRVD2015-01
Page 2

 Short and long term (lifetime) animal toxicity tests, as well as numerous peer-reviewed studies
from the published scientific literature were assessed for the potential of glyphosate to cause
neurotoxicity, immunotoxicity, chronic toxicity, cancer, reproductive and developmental
toxicity, and various other effects. The most sensitive endpoints used for risk assessment
included clinical signs of toxicity and developmental effects. There was no indication that the
young were more sensitive than the adult animal. The risk assessment approach ensures that the
level of exposure to humans is well below the lowest dose at which these effects occurred in
animal tests.
The World Health Organization’s (WHO) International Agency for Research on Cancer (IARC)
recently assigned a hazard classification for glyphosate as “probably carcinogenic to humans”. It
is important to note that a hazard classification is not a health risk assessment. The level of
human exposure, which determines the actual risk, was not taken into account by WHO (IARC).
Pesticides are registered for use in Canada only if the level of exposure to Canadians does not
cause any harmful effects, including cancer.
Residues in Food and Water
Dietary risks from food and water are not of concern.
Reference doses define levels to which an individual can be exposed over a single day (acute) or
lifetime (chronic) and expect no adverse health effects. Generally, dietary exposure from food
and water is acceptable if it is less than 100% of the acute reference dose or chronic reference
dose (acceptable daily intake). An acceptable daily intake is an estimate of the level of daily
exposure to a pesticide residue that, over a lifetime, is believed to have no significant harmful
effects.
Potential acute and chronic dietary exposures to glyphosate were estimated from residues of
glyphosate and relevant metabolites in both treated crops and drinking water. Exposure to
different subpopulations, including children and women of reproductive age, were considered.
The acute dietary exposure estimate (in other words, from food and drinking water) at the 95th
percentile represents 31% of the acute reference dose (ARfD) for females 13-49 years of age and
ranges from 12% to 45% of the ARfD for all other population subgroups. The chronic dietary
exposure estimate for the general population represents 30% of the acceptable daily intake
(ADI). Exposure estimates for population subgroups range from 20% of the ADI (for adults aged
50 years or older) to 70% of the ADI (for children 1-2 years old). Thus, acute and chronic dietary
risks are not of concern.
The Food and Drugs Act prohibits the sale of adulterated food; that is, food containing a
pesticide residue that exceeds the established maximum residue limit (MRL). Pesticide MRLs
are established for Food and Drugs Act purposes through the evaluation of scientific data under
the Pest Control Products Act. Each MRL value defines the maximum concentration in parts per
million (ppm) of a pesticide allowed in or on certain foods. Food containing a pesticide residue
that does not exceed the established MRL does not pose a health risk concern.

Proposed Re-evaluation Decision – PRVD2015-01
Page 3

 Canadian MRLs for glyphosate are currently specified for a wide range of commodities (MRL
database). Residues in all other agricultural commodities, including those approved for treatment
in Canada but without a specific MRL, are regulated under Subsection B.15.002(1) of the Food
and Drug Regulations, which requires that residues do not exceed 0.1 ppm. The current MRLs
for glyphosate can be found in Appendix VII of this document. Separate MRLs have been
established for the trimethylsulfonium (TMS) cation, the major metabolite of the glyphosateTMS salt, in/on a variety of commodities. Given that all glyphosate-TMS-containing products
have been discontinued, it is proposed that all MRLs for the TMS cation be revoked.
Risks in Residential and Other Non-Occupational Environments
Non-occupational risks are not of concern when used according to label directions.
Residential exposure may occur from the application of products containing glyphosate to
residential lawns, and turf (including golf courses). Residential handler exposure would occur
from mixing, loading and applying domestic-class glyphosate products. These products can
be applied as a liquid by a manually pressurized handwand, backpack, sprinkler can and
ready-to-use sprayer.
Residential postapplication exposure may occur while performing activities on treated areas.
Treated areas include areas treated by residential handlers as well as residential areas treated by
commercial applicators. Exposure would be predominantly dermal. Incidental oral exposure may
also occur for children (1 to < 2 years old) playing in treated areas.
For all domestic class products, the target dermal and inhalation margins of exposure (MOE)
were met for adults applying glyphosate and are not of concern. Residential postapplication
activities also met the target dermal MOE for all populations (including golfers) and are not of
concern. For incidental oral exposure, the target oral MOEs were met for children (1 to < 2 years
old) and are not of concern.
Non-occupational scenarios were aggregated with background (chronic) dietary exposure (food
and drinking water). The resulting aggregate risk estimates reached the target MOE for all uses
and are not of concern.
Non-occupational risks from bystander dermal exposure are not of concern.
Bystander exposure may occur when the general public enter non-cropland areas (for example,
hiking through forests or parks) that have recently been treated with glyphosate. The resulting
risk estimates associated with bystander dermal exposure exceeded the target MOE for all
populations and are not of concern.

Proposed Re-evaluation Decision – PRVD2015-01
Page 4

 Occupational Risks from Handling Glyphosate
Occupational risks to handlers are not of concern when used according to label directions.
Risks to handlers are not of concern for all scenarios. Based on the precautions and directions for
use on the original product labels reviewed for this re-evaluation, risk estimates associated with
mixing, loading and applying activities exceeded target dermal and inhalation MOEs and are not
of concern.
Postapplication risks are not of concern for all uses.
Postapplication occupational risk assessments consider exposures to workers entering treated
sites in agriculture. Based on the current use pattern for agricultural scenarios reviewed for this
re-evaluation, postapplication risks to workers performing activities, such as scouting, exceeded
target dermal MOEs and are not of concern. A restricted entry interval of 12 hours is proposed
for agricultural sites.
Polyethoxylated Tallow Amines
POEA is a family of several compounds that are used as surfactants in many glyphosate products
registered in Canada. No human health risks of concern were identified, provided end-use
products contain no more than 20% POEA by weight. All of the currently registered glyphosate
end-use products in Canada meet this limit.
Environmental Considerations
What Happens When Glyphosate Is Introduced Into the Environment?
When used according to proposed label directions, glyphosate products do not
pose an unacceptable risk to the environment. Labelled risk-reduction measures
mitigate potential risks posed by glyphosate formulations to non-target plants and
freshwater/marine/estuarine organisms.
When glyphosate is released into the environment, it can enter soil and surface water. Glyphosate
breaks down in soil and water and is not expected to persist for long periods of time. Glyphosate
produces one major transformation product in soil and water, aminomethyl phosphonic acid
(AMPA), which can persist in the environment. Carryover of glyphosate and AMPA into the
next growing season is not expected to be significant. Glyphosate and AMPA are not expected to
move downward through the soil and are unlikely to enter groundwater.
Glyphosate dissolves readily in water but is expected to move into sediments in aquatic
environments. Glyphosate is not expected to enter the atmosphere. Glyphosate and AMPA are
unlikely to accumulate in animal tissues.
Certain glyphosate formulations include a surfactant composed of POEA compounds. At high
enough concentrations, POEA is toxic to aquatic organisms but is not expected to persist in the

Proposed Re-evaluation Decision – PRVD2015-01
Page 5

 environment. While, in general, glyphosate formulations that contain POEA are more toxic to
freshwater and marine/estuarine organisms than formulations that do not contain POEA, they do
not pose an unacceptable risk to the environment when used as directed on the label.
In the terrestrial environment the only area of risk concern identified from the available data was
for terrestrial plants and therefore spray buffer zones are required to reduce exposure to sensitive
terrestrial plants.
Glyphosate formulations pose a negligible risk to freshwater fish and amphibians, but may pose
a risk to freshwater algae, freshwater plants, marine/estuarine invertebrates and marine fish if
exposed to high enough concentrations. Hazard statements and mitigation measures (spray buffer
zones) are required on product labels to protect aquatic organisms.
Glyphosate, AMPA and POEA do not meet all Toxic Substances Management Policy (TSMP)
Track 1 criteria and are not considered Track 1 substances. Other than incident reports of damage
to plants, there are currently no environmental incident reports involving glyphosate in Canada.
Value Considerations
What is the Value of Glyphosate?
Glyphosate plays an important role in Canadian weed management in both agricultural
production and non-agricultural land management and is the most widely used herbicide
in Canada.
Glyphosate is an important herbicide for Canadian agriculture, for the following reasons:
•

•
•
•
•

Due to its broad and flexible use pattern and its wide weed-control spectrum, it is the
most widely used herbicide in several major crops grown in Canada such as canola,
soybean, field corn and wheat. It is also one of only a few herbicides regularly used in
fruit orchards such as apple.
It is the essential herbicide for use on the glyphosate tolerant crops (GTCs) including
canola, soybean, corn, sweet corn and sugar beet. The combination of GTCs and
glyphosate has been adopted as an important agricultural production practice in Canada.
It has a wide application window ranging from pre-seeding to after seeding (prior to crop
emergence), in-crop, pre-harvest or post-harvest, providing a flexible and effective weed
management program.
It is one of few herbicides that can also be used as harvest management and desiccation
treatment.
Post-harvest stubble treatment with glyphosate allows reduced or zero tillage, which has
facilitated the adoption of conservation agriculture that results in improved soil quality.

Proposed Re-evaluation Decision – PRVD2015-01
Page 6

 Glyphosate is also an important weed management tool and is widely used for weed control in
non-agricultural land management, such as forestry, industrial areas, and along rights-of-way. It
is an effective tool for control of many invasive weed species and is also used in the control of
toxic plants such as poison ivy.

Proposed Measures to Minimize Risk
Labels of registered pesticide products include specific instructions for use. Directions include
risk-reduction measures to protect human health and the environment. These directions must be
followed by law. As a result of the re-evaluation of glyphosate, the PMRA is proposing further
risk-reduction measures for product labels.
Human Health
•

To protect workers entering treated sites a restricted-entry interval of 12 hours is
proposed for agricultural uses.

•

To protect bystanders, a statement indicating to apply only when the potential for drift to
areas of human habitation or areas of human activity such as houses, cottages, schools
and recreational areas is minimal is required.

Environment
•

Environmental hazard statements to inform users of its toxicity to non-target species.

•

Spray buffer zones to protect non-target terrestrial and aquatic habitats are required.

•

To reduce the potential for runoff of glyphosate to adjacent aquatic habitats,
precautionary statements for sites with characteristics that may be conducive to runoff
and when heavy rain is forecasted are required. In addition, a vegetative strip between the
treatment area and the edge of a water body is recommended to reduce runoff of
glyphosate to aquatic areas.

What Additional Scientific Information is Being Requested?
There are no additional data requirements proposed as a condition of continued registration of
glyphosate products.

Proposed Re-evaluation Decision – PRVD2015-01
Page 7

 Next Steps
Before making a final re-evaluation decision on glyphosate, the PMRA will consider any
comments received from the public in response to this consultation document. A science-based
approach will be applied in making a final decision on glyphosate. The PMRA will then publish
a Re-evaluation Decision 2 that will include the decision, the reasons for it, a summary of
comments received on the proposed decision and the PMRA’s response to these comments.

2

“Decision statement” as required by subsection 28(5) of the Pest Control Products Act.

Proposed Re-evaluation Decision – PRVD2015-01
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 Science Evaluation
1.0

Introduction

Glyphosate is a non-selective systemic herbicide. As an aminophosphonic analogue of the
natural amino acid glycine, glyphosate is classified as a Weed Science Society of America
Group 9 herbicide. It disrupts the shikimic acid pathway through inhibition of the enzyme
5-enolpyruvylshikimate-3-phosphate (EPSP) synthase. The resulting deficiency in EPSP
production leads to reductions in aromatic amino acids (phenylalanine, tyrosine and tryptophan)
that are vital for protein synthesis and plant growth.
Following the re-evaluation announcement for glyphosate, the registrants of the technical grade
active ingredient indicated their support to continue registration of all uses included on the
labels of end-use products (EPs) containing glyphosate in Canada. Registrants of all Canadian
glyphosate products are listed in Appendix I.

2.0

The Technical Grade Active Ingredient, Its Properties and Uses

2.1

Identity of the Technical Grade Active Ingredient

Common Name

Glyphosate

Function

Herbicide

Chemical Family

Organophosphorus

Chemical Name
1

International Union of Pure
and Applied Chemistry
(IUPAC)

N-(phosphonomethyl)glycine

2

Chemical Abstracts Service
(CAS)

N-(phosphonomethyl)glycine

CAS Registry Number

1071-83-6

Molecular Formula

C3H8NO5P

Structural Formula

O
HOOC CH2 NH

CH2 P
OH

Molecular Weight

169.1

Proposed Re-evaluation Decision – PRVD2015-01
Page 9

OH

 The purity (in other words, guarantee) of the currently registered technical grade active
ingredient is provided in Appendix I.
Identity of relevant impurities of human health or environmental concern include the following:
Based on the manufacturing process used, impurities of human health or environmental concern
as identified in the Canada Gazette, Part II, Vol. 142, No. 13, SI/2008-67 (2008-06-25),
including TSMP Track 1 substances, are not expected to be present in the product.
2.2

Physical and Chemical Properties of the Technical Grade Active Ingredient

Property

Result

Vapour pressure at 25°C

1.31 × 10-2 mPa

Ultraviolet (UV) / visible spectrum

Not expected to absorb at λ > 300 nm

Solubility in water at 20°C

10.5 g/L (pH 1.9)

n-Octanol/water partition coefficient at 20 °C

Log Kow < -3.2 (pH 2-5); Kow < 6.3 × 10-4

Dissociation constant (pKa)

2.34 (20ºC), 5.73 (20ºC), 10.2 (25ºC)

2.3

Polyethoxylated Tallow Amines

Polyethoxylated tallow amines (POEA) are surfactants consisting of a family of many
compounds. The general structure for POEA is as follows:
R
H

O

N
m

O

H
n

In Canada, majority of the currently registered glyphosate end-use products contain the
surfactant POEA.
2.4

Description of Registered Glyphosate Uses

Appendix I lists all glyphosate products that are registered under the authority of the Pest
Control Products Act as of 3 May 2012. A total of 169 products contain glyphosate including
19 technical grade active ingredients, 19 Manufacturing Concentration, 97 Commercial Class
end-use products and 34 Domestic Class end-use products. Although glyphosate is registered
in various forms, there are no differences in efficacy and toxicity end-points among glyphosate
forms. Therefore, the assessments were based on the glyphosate acid form.

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 Appendix IIa and IIb list all the Commercial Class and Domestic Class uses, respectively, for
which glyphosate is currently registered. All uses including uses registered through the PMRA
User Requested Minor Use Label Expansion (URMULE) program were supported by the
registrants at the time of initiation of re-evaluation and were therefore considered in the health
and environmental risk assessments. Under the URMULE program, the data supporting the
minor use registrations are generated by a user group or by the Pest Management Centre of
Agriculture and Agri-Food Canada.
Uses of glyphosate belong to the following use site categories: Forests and Woodlots (Use-Site
Category (USC 4), Industrial Oil Seed Crops and Fibre Crops (USC 7), Terrestrial Feed Crops
(USC 13), Terrestrial Food Crops (USC 14), Industrial and Domestic Vegetation Control
Non-food Sites (USC 16), Ornamentals Outdoors (USC 27) and Turf (USC 30).

3.0

Impact on Human and Animal Health

3.1

Toxicology Summary

The toxicology database for glyphosate acid (hereafter called glyphosate) was extensive,
consisting of all guideline toxicity studies required to characterize toxicity of a pesticide.
For each study type currently required, several studies were available to satisfy the data
requirements. Considered individually, some of these studies do not meet the current standards
for testing, although they were considered acceptable at the time of their initial evaluation.
Overall, the database was considered adequate to define the majority of the toxic effects that may
result from exposure to glyphosate. Relevant acceptable scientific studies published in the peerreviewed literature were also incorporated into the hazard assessment, including those studies
that were considered by the World Health Organization’s (WHO) International Agency for
Research on Cancer (IARC) in their recent hazard classification for glyphosate. Hazard
identification, including carcinogenic potential, is an important component in the determination
of the potential human health risk of a pesticide. The determination of such risk, however, is not
solely driven by the hazard profile but is also a function of the potential exposure to the
pesticide. For this reason, both the hazard and exposure potential must be considered together
when performing a human health risk assessment for a pesticide, since an identified hazard may
be offset by the fact that the potential for human exposure is considered to be sufficiently low so
as not to pose a risk of concern to human health.
Metabolism studies in rats indicated that glyphosate was incompletely but rapidly absorbed
following administration of single low, single high and repeated oral doses. At low doses, the
peak plasma concentration was reached within an hour of dosing. Following single high doses,
the peak plasma concentration was reached five hours after dosing. The bioavailable fraction was
about 20-23%. The parent compound was the primary form detected in tissues and excreta,
indicating glyphosate was not metabolized extensively. Approximately 1-5% of the administered
dose (AD) was distributed in the gastrointestinal (GI) tract, liver, kidneys, bone, lungs, spleen,
salivary glands and brain. The distribution phase was rapid with a distribution half-life of
20-30 minutes. About 1-9% of the AD was metabolized to aminomethylphosphonic acid
(AMPA). Higher quantities (6-9% of AD) of AMPA were detected in feces than in urine

Proposed Re-evaluation Decision – PRVD2015-01
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 (≤1% of AD). In single low- or high-dose oral studies, the excretion of glyphosate was rapid and
nearly complete after 72 hours. The primary route of excretion was the feces (80-90% of AD)
followed by urine (10-20% of AD) following single low, single high, and repeated oral doses.
The elimination half-life of glyphosate was around 14 hours while the elimination half-life of
AMPA was approximately 15 hours following oral doses of glyphosate.
Glyphosate was of low acute oral and inhalation toxicity in the rat, and of low dermal toxicity in
the rabbit. Glyphosate was neither a dermal irritant nor a dermal sensitizer. It was severely
irritating to rabbit eyes.
In oral repeat-dose toxicity studies, effects on salivary glands in rodents, decreased body weight,
body-weight gain, and clinical signs of toxicity were consistently observed in all test species.
Additional target organs of toxicity were liver and kidney in rats and dogs, and stomach in mice
in most of these studies at higher dose levels. Changes in several clinical chemistry parameters
were consistent with a mild dehydration. The high doses in most studies reached or exceeded the
limit dose of testing (in other words, 1000 mg/kg bw/day) due to the low toxicity of glyphosate.
In guideline and non-guideline (National Toxicology Program-NTP) 90-day oral studies in
rodents, the primary effect in rats was an increased incidence and severity of cytoplasmic
alterations of the parotid and submandibular glands. Although this effect was also noted in mice,
it occurred at a dose that exceeded the limit dose. The effects in the parotid gland in Sprague
Dawley rats was considered to be at the threshold of toxicological adversity at the lowest dose
tested (30 mg/kg bw/day) due to the mild nature of this effect, and given that these effects in the
rat salivary glands were commonly observed starting at 100 mg/kg bw/day in other toxicity
studies. In a 28-day oral study, salivary gland effects were noted in three rat strains at the limit
dose, but with varying degrees of severity and reversibility. A 14-day mechanistic oral study in
rats designed to test the hypothesis that the salivary gland effects of glyphosate were mediated
through an adrenergic pathway did not provide conclusive evidence to substantiate this
mechanism.
Other effects noted in the short-term studies included increased kidney and lungs weights in male
mice, and decreased thymus weights, body weight, body-weight gain, and increased plasma bile
acids in rats. In addition, decreased sperm counts were also noted in rats at dose groups where
sperm analysis was conducted (three highest doses), with increased testis weights observed at
higher dose levels. However, no effects were observed in the other examined sperm parameters
(epididymal weights, epididymal sperm motility, total spermatid heads, and total spermatid
heads/gram caudal tissue). The estrus cycle length was also slightly longer (5.4 days compared to
4.9 days) in the high-dose females.
In the 21-day dermal toxicity studies in rats and rabbits, no treatment-related systemic or dermal
effects were noted in Wistar rats at doses up to 1000 mg/kg bw/day, while SD rats had increased
incidences of erythema and desquamation of the skin and increased incidences of unilateral
papillary necrosis, urothelial hyperplasia and pelvic dilation in the kidneys at this dose. Slight
dermal irritation, but no systemic toxicity was observed in New Zealand White (NZW) rabbits.
In a 90-day dog study, the only adverse effects noted were decreases in several clinical chemistry
parameters at a very high dose, which were consistent with decreased food consumption.
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 Decreased ovary weights and increased serum ALP were also observed in females at the high
dose. Three 12-month dog studies reported more systemic toxicity (body weight and epididymal
effects) at lower dose levels in males compared to females. However, males were not more
sensitive than females in other test species. One 12-month study had increased incidences of
clinical signs of toxicity and increased liver and kidney weights in males. A second study
reported a dose-related increased incidence of lymphoid nodules in the epididymis and decreased
pituitary weight in males, with kidney tubular regeneration accompanied by epithelial cells and
urinary protein in females at this same dose. Increased absolute and relative testis and ovary
weights were found in the high-dose group.
A third study reported decreased levels of plasma phosphorus, decreased epididymides weights
and increased transitional epithelial hyperplasia in the kidneys in males, with decreased plasma
phosphorus levels and thyroid weights in the high-dose females only.
Glyphosate was not genotoxic in the standard battery of in vitro and in vivo tests assessing gene
mutation, chromosome aberration, and mouse micronucleus anomalies. There was no evidence
of carcinogenicity in four long-term rat studies. In mice, treatment with glyphosate was
associated with a marginal increase in the incidence of unilateral tubulostromal adenomas in the
ovaries, but only at the limit dose of testing. Although historical control data were unavailable,
based on the marginal increase in the incidence of the ovarian tumours coupled with its
occurrence at the limit dose and the negative findings in a battery of genotoxicity assays, these
tumours were considered to be of low concern for human health risk assessment.
Chronic effects were assessed in four long-term rat toxicity studies. One study did not elicit
any overt toxicity as the dose range was insufficiently high, whereas the high-dose group in the
other three studies either exceeded or was at the limit dose of testing. Effects included increased
incidences and severity of cellular alteration in the submandibular and parotid glands, and
inflammation and hyperplasia of the squamous mucosa in the stomach in both sexes; decreased
and/or absence of epididymal sperm, degeneration of seminiferous tubules, increased testis
weight and testicular effects, and myeloid hyperplasia of the bone marrow in males; and
increased kidney papillary necrosis in females. At or above the limit dose, males had a
marginally increased incidence of necrosis in the glandular stomach and an increase in kidney
papillary necrosis and prostatitis, while females had increased incidences of mammary gland
hyperplasia and cataracts/lens fiber degeneration.
In three gavage rat developmental-toxicity studies, the high doses reached or exceeded the limit
dose and no evidence for sensitivity of the young was observed. Maternal toxicity occurred at the
limit dose in rats and included clinical signs of toxicity (salivation, and noisy respiration),
hydronephrosis and one total litter resorption. In addition, mortality, and decreased body weight
and body-weight gain were observed at doses above the limit dose. Developmental toxicity was
also observed only at or above the limit dose. Effects comprised an increased incidence of
skeletal variants, wavy ribs/rib distortions and hydroureter. Decreased fetal weight, reduced
ossification, decreased numbers of viable fetuses/dam, and an increased incidence of absent
kidneys and ureters were also observed at a dose that exceeded the limit dose by over three-fold.
In three gavage developmental toxicity studies in rabbits, maternal toxicity comprised mainly of
GI disturbances at similar dose levels, with excessive maternal mortality occurring at higher
Proposed Re-evaluation Decision – PRVD2015-01
Page 13

 doses in one study. Post-implantation loss and intra-uterine deaths were commonly noted at the
highest dose tested. Developmental toxicity included decreased fetal body weight, reduced
ossification, and increased incidences of 27th presacral vertebrae, and 13th rudimentary and full
ribs. In one study an increased incidence of fetal cardiovascular variations accompanied with an
increased incidence of fetal cardiovascular malformations (mainly interventricular septal defects)
was noted at the highest dose tested. The observation of cardiovascular malformations was
considered a serious effect in this study, although maternal toxicity was present at the same dose
level. No evidence of sensitivity of the young was noted.
The reproductive toxicity of glyphosate was investigated in three, two-generation toxicity studies
in rats. In two of these studies, the high dose reached or exceeded the limit dose. Parental toxicity
included an increased incidence of hypertrophy of acinar cells with granular cytoplasm in the
parotid and submandibular glands in both parental generations. At doses at or above the limit
dose, there was decreased body weight and an increased incidence of soft stools or diarrhea in
both parental generations, decreased body weight during gestation in F1 females, increased liver
and kidney weights in the P generation with increased incidences of transitional epithelial
hyperplasia in the kidney, and glandular and luminal dilatation of the uterus in the F1 generation.
Reproduction toxicity was noted only at a dose that exceeded the limit dose and included
decreased litter size with no increase in the number of dead pups per litter. There were no effects
on mating, pregnancy and fertility indices, sperm parameters, or reproductive performance.
However, an increased mean number of estrual cycles (P generation) and decreased mean estrual
cycle length (P and F1 generations) in females was noted at the limit dose. Offspring toxicity
consisted primarily of decreased body weight in pups. At doses at or exceeding the limit dose,
there were decreases in litter size, a marginal increase in tubular dilatation/cysts in the kidneys,
decreased pup spleen and thymus weights and an increased incidence of unilateral and bilateral
pelvic dilatation of the kidneys. Although decreased body weight in pups was observed at
non-maternally toxic dose in two of the three studies, this reduction in body weight was
considered marginal and evidence from other studies in rats indicated that effects on the salivary
glands (not assessed in these two reproduction toxicity studies) would be expected to occur at
this dose level in the adult animals. Thus, no evidence of sensitivity of the young was observed
in these reproduction toxicity studies.
The neurotoxic potential of glyphosate was investigated in acute and 90-day oral neurotoxicity
studies in rats. In the acute oral (gavage) neurotoxicity study, decreased motor activity was
observed in females on the first day of dosing. An increased incidence of reduced splay reflex
and decreased motor activity in males was observed along with other findings (decreased
activity, subdued behaviour, hunched posture, pinched in sides, tip-toe gait, hypothermia,
abnormal respiratory noise, diarrhea, and a single mortality in females) at a dose level that was
two-fold greater than the limit dose. In the 90-day dietary neurotoxicity study, decreased bodyweight gain and food efficiency were noted in males. In the high-dose group, decreased body
weight and an increased incidence of decreased pupillary response to light were observed in
males. Decreased body-weight gain and motor activity on week 5 were observed in females of
the high-dose group. Overall, findings in both acute and short-term neurotoxicity studies were
considered to reflect systemic/general toxicity rather than evidence of selective neurotoxicity.

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 In a 28-day immunotoxicity study, dose-related increased T-cell dependent antibody response
and total spleen activity were observed in the test animals. In addition, a non-dose related
increase in spleen cellularity was noted. Although this test was designed to examine
immunosuppression, an altered function of the immune system could not be ruled out.
Epidemiology
A number of published epidemiology studies were reviewed for incorporation into the hazard
assessment of glyphosate, which included the subset of epidemiological information considered
by the WHO (IARC) in their summary report for glyphosate. However, the majority lacked
adequate characterization of glyphosate exposure, rendering them of limited use for
supplementing the hazard assessment. A prospective cohort study of licensed pesticide
applicators in Iowa and North Carolina, known as the Agricultural Health Study, examined the
relationship between glyphosate exposure and cancer incidence. The most relevant finding in this
study was the suggested association between multiple myeloma and glyphosate exposure.
However, a number of confounding factors (for example, the lack of consideration of exposure to
UV radiation from sunlight) rendered these findings inconclusive and chance occurrence could
not be ruled out. The study investigators also indicated that this association required additional
follow-up.
Cancer Assessment
In consideration of the strength and limitations of the large body of information on glyphosate,
which included multiple short and long term (lifetime) animal toxicity studies, numerous in vivo
and in vitro genotoxicity assays, as well as the large body of epidemiological information, the
overall weight of evidence indicates that glyphosate is unlikely to pose a human cancer risk. This
is consistent with all other pesticide regulatory authorities world-wide, including the most recent,
ongoing comprehensive re-evaluation by Germany (Rapporteur Member State for the European
Union) that was published for public consultation in 2014 (http://dar.efsa.europa.eu/darweb/provision).
Toxicity Studies on the Metabolite Aminomethylphosphonic Acid
In a single dose metabolism study with radiolabelled metabolite aminomethylphosphonic acid
(AMPA), absorption was incomplete. Small quantities of AMPA were recovered in most tissues,
with the highest percent detected in the muscle and the GI tract. Over 90% of the AD was
excreted as unchanged AMPA, indicating that AMPA was not further metabolized. Most of the
excretion occurred via feces compared to urine. Overall, this study showed that AMPA
possessed metabolic patterns that were similar to those of its parent compound, glyphosate.
AMPA was of low acute oral and dermal toxicity in the rat. AMPA was neither a dermal irritant
in rabbits nor a dermal sensitizer in guinea pigs. It was minimally irritating to rabbit eyes.
In a 90-day oral study in rats, decreased liver weights were observed in males. An increased
incidence and severity of mucosal hyperplasia of the bladder was also observed at a dose level
greater the limit dose. Decreased body weight, and body-weight gain were observed in males.
Proposed Re-evaluation Decision – PRVD2015-01
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 An increased incidence of renal pelvic epithelial hyperplasia was observed at a dose that was
about five-fold greater than the limit dose. In a supplemental oral 90-day study in rats, a slight
reduction in body-weight gain in females and a slight increase in kidney weights in males were
observed at the limit dose.
In a 30-day oral study in dogs, decreased red blood cell counts, hemoglobin concentration, and
hematocrit levels were noted in females in all dose groups and in the high-dose group in males.
Increased reticulocyte counts also accompanied these effects. However, in a 90-day oral study in
dogs, no toxicity was observed at similar dose levels.
AMPA tested negative for gene mutation tests in bacteria and mammalian lymphoma cell lines
and also tested negative in mouse micronucleus and unscheduled DNA synthesis assays.
In a gavage developmental toxicity study in rats, increased incidences of hair loss and soft and
mucoid feces were noted in dams. Decreased body weight, body-weight gain and food
consumption was observed at the limit dose of testing. Developmental toxicity included
decreased body weight at the limit dose. No evidence of the sensitivity of the young was
observed in this study. In a supplemental developmental toxicity study, no maternal toxicity was
noted. Developmental toxicity included increased incidences of reduced ossification and skeletal
variations.
Overall, based on the available toxicity studies, AMPA was considered of no greater
toxicological concern than glyphosate. Although no repeated dose toxicity studies were available
for glyphosate metabolites resulting from genetically modified organism (GMO) crops (in other
words, N-acetylglyphosate and N-acetyl AMPA), these metabolites were not considered to be of
a greater toxicological concern than the parent compound, glyphosate, based on a European Food
Safety Authority assessment. In summary, glyphosate toxicology endpoints were considered
adequate for the risk assessment of AMPA and the acetylated metabolites of glyphosate.
Results of the toxicology studies conducted on laboratory animals with glyphosate and AMPA
are summarized in Table 1A and Table 1B of Appendix III, respectively. The toxicology
endpoints for use in the human health risk assessment are summarized in Table 2 of
Appendix III.
Pest Control Products Act Hazard Characterization
For assessing risks from potential residues in food or from products used in or around homes or
schools, the Pest Control Products Act requires the application of an additional 10-fold factor to
threshold effects to take into account the completeness of the data with respect to the exposure
of and toxicity to infants and children, and potential prenatal and postnatal toxicity. A different
factor may be determined to be appropriate on the basis of reliable scientific data.

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 With respect to completeness of the toxicity database as it pertains to the toxicity to infants and
children, the database contains several studies for each type of required guideline study including
developmental toxicity studies in rats and rabbits, and two-generation reproduction toxicity
studies in rats. In addition, applicable studies from the published scientific literature were
considered, including reviews of studies that were submitted to the European Union Glyphosate
Task Force.
With respect to identified concerns relevant to the assessment of risk to infants and children,
the two-generation reproduction toxicity studies in rats provided no indication of increased
sensitivity of the young. In these studies, offspring toxicity commonly consisted of decreased
body weight observed at dose levels that produced toxicity to the adult animals. In addition, the
prenatal developmental toxicity studies in rats did not demonstrate increased sensitivity of the
fetuses to in utero exposure of glyphosate. In these studies, decreased fetal weights and number
of viable fetus/dam, in addition to developmental abnormalities (absent kidneys and ureters,
skeletal variants, wavy ribs, a single incidence of hydroureter) were observed at dose levels that
reached or exceeded the limit dose and produced moderate to severe toxicity in maternal
animals.
In developmental toxicity studies in the rabbits, there was no observed increase in susceptibility
of the fetuses to in utero exposure of glyphosate. In these studies, an increased incidence of
reduced ossification at various sites was commonly noted at dose levels that produced maternal
toxicity. In one of these studies, an increased incidence of fetal cardiovascular malformations,
comprised mainly of interventricular septal defects, was noted in the presence of maternal
toxicity at the highest dose tested.
Overall, the endpoints in the young were well characterized. The increased incidence of fetal
cardiovascular malformations noted in a rabbit developmental toxicity study was considered a
serious endpoint. However, the concern regarding the serious nature of this effect was tempered
by the presence of maternal toxicity at the same and lower dose levels in this study. Therefore,
the Pest Control Products Act factor was reduced to three-fold when this endpoint was used to
establish the point of departure. For all other scenarios, the Pest Control Products Act factor was
reduced to one-fold since there were no residual uncertainties with respect to the completeness of
the data, or with respect to potential toxicity to infants and children.
3.2

Dietary Exposure and Risk Assessment

In a dietary exposure assessment, the PMRA determines how much of a pesticide residue,
including residues in milk and meat, may be ingested with the daily diet. Exposure to glyphosate
from potentially treated imported foods is also included in the assessment. These dietary
assessments are age specific and incorporate the different eating habits of the population at
various stages of life (infants, children, adolescents, adults and seniors). For example, the
assessments take into account differences in children’s eating patterns, such as food preferences
and the greater consumption of food relative to their body weight when compared to adults.
Dietary risk is then determined by the combination of the exposure and the toxicity assessments.
High toxicity may not indicate high risk if the exposure is low. Similarly, there may be risk from
a pesticide with low toxicity if the exposure is high.
Proposed Re-evaluation Decision – PRVD2015-01
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 The PMRA considers limiting use of a pesticide when risk exceeds 100% of the reference dose.
The PMRA Science Policy Note SPN2003-03, Assessing Exposure from Pesticides, A User’s
Guide, presents detailed acute, chronic and cancer-risk assessment procedures.
Residue estimates used in the dietary risk assessment may be based conservatively (in other
words, use upperbound estimates) on the maximum residue limits (MRLs) or the field trial data
representing the residues that may remain on food after treatment at the maximum label rate.
Surveillance data representative of the national food supply may also be used to derive a more
accurate estimate of residues that may remain on food when it is purchased. These include the
Canadian Food Inspection Agency (CFIA) National Chemical Residue Monitoring Program and
the United States Department of Agriculture Pesticide Data Program (USDA PDP). Specific and
empirical processing factors as well as specific information regarding percent of crops treated
may also be incorporated to the greatest extent possible.
In situations where the need to mitigate dietary exposure has been identified, the following
options are considered. Dietary exposure from Canadian agricultural uses can be mitigated
through changes in the use pattern. Revisions of the use pattern may include such actions as
reducing the application rate or the number of seasonal applications, establishing longer
pre-harvest intervals (PHIs), and/or removing uses from the label. In order to quantify the impact
of such measures, new residue chemistry studies that reflect the revised use pattern would be
required. These data would also be required in order to amend MRLs to the appropriate level.
Imported commodities that have been treated also contribute to the dietary exposure and are
routinely considered in the risk assessment. The mitigation of dietary exposure that may arise
from treated imports is generally achieved through the amendment or specification of MRLs.
Acute and chronic exposure and risk assessments were conducted using the Dietary Exposure
Evaluation Model – Food Commodity Intake DatabaseTM (DEEM-FCIDTM, Version 2.14), which
incorporates consumption data from the United States Department of Agriculture (USDA)
Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994 to 1996 and 1998. For
more information on dietary risk estimates or residue chemistry information used in the dietary
assessment, see Appendices IV, V and VI.
3.2.1

Determination of Acute Reference Dose

General Population (Excluding Females 13-49 Years of Age)
To estimate acute dietary risk (one day), a rabbit developmental toxicity study with a no
observed adverse effect level (NOAEL) of 100 mg/kg bw/day was selected for risk assessment.
An increased incidence of soft stools and diarrhea was observed immediately following the start
of dosing at 175 mg/kg bw/day. Standard uncertainty factors of 10-fold for interspecies
extrapolation and 10-fold for intraspecies variability were applied. The Pest Control Products
Act factor was reduced to one-fold for the reasons outlined in the Pest Control Products Act
Hazard Characterization section. Therefore, the composite assessment factor (CAF) is 100.

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 The ARfD is calculated according to the following formula:
ARfD = NOAEL = 100 mg/kg bw/day = 1.0 mg/kg bw of glyphosate
CAF
100
Females 13-49 years of age
To estimate acute dietary risk (one day) for females 13-49 years of age, a rabbit developmental
toxicity study with a NOAEL of 150 mg/kg bw/day was selected for risk assessment. An
increased incidence of cardiovascular malformations was observed at 450 mg/kg bw/day.
Standard uncertainty factors of 10-fold for interspecies extrapolation and 10-fold for intraspecies
variability were applied. The Pest Control Products Act factor was reduced to three-fold for the
reasons outlined in the Pest Control Products Act Hazard Characterization section. Therefore,
the composite assessment factor (CAF) is 300.
The ARfD is calculated according to the following formula:
ARfD = NOAEL = 150 mg/kg bw/day = 0.5 mg/kg bw of glyphosate
CAF
300
3.2.2

Acute Dietary Exposure and Risk Assessment

The acute dietary risk was calculated considering the highest ingestion of glyphosate that would
be likely on any one day, and using food consumption and food residue values. The expected
intake of residues is compared to the ARfD, which is the dose at which an individual could be
exposed on any given day and expect no adverse health effects. When the expected intake of
residues is less than the ARfD, then acute dietary exposure is not of concern.
The acute dietary exposure assessments were conducted for the acid form of glyphosate
(including all the metabolites comprised in the residue definition), which is considered to be
the common moiety for all currently registered forms of glyphosate.
Following the PMRA’s tiered approach, basic (in other words, upperbound) exposure
assessments were performed for females 13-49 years old and all other population subgroups by
using MRL/tolerance-level residues for all commodities, default processing factors and assuming
that all crops were 100% treated. Canadian MRLs, United States tolerances or Codex MRLs,
whichever was greater, were used for all crops, including imports. Drinking water contribution
to the exposure was accounted for by direct incorporation of the appropriately estimated
environmental concentration (EEC), obtained from water modelling (see Section 3.3.1), into the
dietary exposure evaluation model.
The acute exposure estimate at the 95th percentile for females 13-49 years old is 31% of the
ARfD and therefore is not of concern. Acute exposure estimates at the 95th percentile for
population subgroups other than females 13-49 years old range from 12% to 45% of the ARfD
and therefore are also not of concern.

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 3.2.3

Determination of Acceptable Daily Intake

To estimate dietary risk of long-term exposure, the 26-month chronic toxicity and
carcinogenicity study in rats with a NOAEL of 32/34 mg/kg bw/day was selected for risk
assessment. No treatment-related effects were noted in this study. This was the highest
(combined) NOAEL for the long-term toxicity studies in rats. The lowest (combined) LOAEL
was 100 mg/kg bw/day, based on reduction in body weight in male rats in the interim
sacrifice and increased incidences and severity of cellular alterations in the parotid and
submandibular glands in a 24-month chronic toxicity and carcinogenicity study in rats. These
NOAELs/LOAELs were further supported by the NOAEL of 30 and the lowest observed adverse
effect level (LOAEL) of 100 mg/kg bw/day in one-year studies in dogs. Standard uncertainty
factors of 10-fold for interspecies extrapolation and 10-fold for intra-species variability were
applied. The Pest Control Products Act was reduced to one-fold for the reasons outlined in the
Pest Control Products Act Hazard Characterization section. Therefore, the CAF is 100.
The ADI is calculated according to following formula:
ADI = NOAEL = 32 mg/kg bw/day = 0.3 mg/kg bw/day of glyphosate
CAF
100
This ADI provides a margin of 500 to the NOAEL of 150 mg/kg bw/day for the fetal
cardiovascular malformations in the rabbit developmental toxicity study.
3.2.4

Chronic Dietary Exposure and Risk Assessment

The chronic dietary risk was calculated by using the average consumption of different foods and
the average residue values on those foods. This expected intake of residues was then compared
to the ADI. When the expected intake of residues is less than the ADI, then chronic dietary
exposure is not of concern.
The chronic dietary exposure assessments were conducted for the acid form of glyphosate
(including all the metabolites comprised in the residue definition), which is considered to be the
common moiety for all currently registered forms of glyphosate.
Following the PMRA’s tiered approach, basic (in other words, upperbound) exposure
assessments were performed for the general population and all population subgroups by using
MRL/tolerance-level residues for all commodities, default processing factors and assuming that
all crops were 100% treated. Canadian MRLs, US tolerances or Codex MRLs, whichever was
greater, were used for all crops, including imports. Drinking water contribution to the exposure
was accounted for by direct incorporation of the appropriate EEC, obtained from water
modelling (see Section 3.3.1), into the dietary exposure evaluation model.
The chronic exposure estimate for the general population is 30% of the ADI and, therefore, is not
of concern. Exposure estimates for population subgroups range from 20% to 70% of the ADI
and, therefore, are not of concern.

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 3.3

Exposure from Drinking Water

Residues of glyphosate and its metabolite aminomethylphosphonic acid (AMPA) in potential
drinking water sources were estimated from modelling.
3.3.1

Concentrations in Drinking Water

Drinking water EECs of combined residues of glyphosate and its transformation product AMPA
in potential sources of drinking water were calculated using PRZM/EXAMS models for a small
reservoir. EECs in groundwater were not calculated as leaching to groundwater was not detected.
Most scenarios were run using 50-year weather data. Level 2 (refined) surface water modelling
was carried out with nine scenarios across Canada to reflect typical crop uses, application rates
and timing and application methods. The highest surface water reservoir daily peak EEC value of
0.267 ppm and yearly average EEC value of 0.197 ppm for combined residues of glyphosate and
AMPA (please refer to Appendix XI, Table XI.7) were used in the acute and the chronic dietary
exposure assessments, respectively.
3.3.2

Drinking Water Exposure and Risk Assessment

Drinking water exposure estimates were combined with food exposure estimates, with EEC point
estimates incorporated directly in the dietary (food + drinking water) assessments. Please refer to
Sections 3.2.2 and 3.2.4 for details.
3.4

Occupational and Non-Occupational Exposure and Risk Assessment

For the purpose of this assessment, information was summarized for glyphosate and each of the
five salt forms. This integration of information was based on the fact that the majority of use
patterns among the salt forms are similar and that although variations exist in terms of the range
of use sites and rates of applications, these differences are limited.
Occupational and non-occupational risk is estimated by comparing potential exposures with the
most relevant endpoint from toxicology studies to calculate a margin of exposure (MOE). This
is compared to a target MOE incorporating uncertainty factors protective of the most sensitive
subpopulation. If the calculated MOE is less than the target MOE, it does not necessarily mean
that exposure will result in adverse effects, but mitigation measures to reduce risk would be
required.

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 3.4.1

Toxicology Endpoint Selection for Occupational and Non-Occupational Risk
Assessment

Incidental Oral, Short-term Dermal and Inhalation Routes
For incidental oral and occupational/bystander risk assessments for short-term dermal and
inhalation routes, a 90-day oral study in rats was selected. A NOAEL was not established in
this study. The LOAEL was 30 mg/kg bw/day based on an increased incidence and severity of
cellular alteration in the parotid gland. This LOAEL was considered to be at the threshold of
toxicological adversity due to the mild nature of the cellular alteration in the parotid glands at
this dose level. As a result, an uncertainty factor (UFL) for extrapolating from a LOAEL to a
NOAEL was not deemed necessary. Standard uncertainty factors of 10-fold for interspecies
extrapolation and 10-fold for intraspecies variability were applied. Therefore, the target Margin
of Exposure (MOE) is 100.
Intermediate- and Long-term Dermal and Inhalation Routes
For occupational/bystander risk assessments for intermediate- and long-term and dermal
and inhalation routes, the 26-month chronic toxicity and carcinogenicity study in rats with a
NOAEL of 32/34 mg/kg bw/day was selected for risk assessment. No treatment-related effects
were noted in this study. This was the highest (combined) NOAEL for the long-term toxicity
studies in rats. The lowest (combined) LOAEL was 100 mg/kg bw/day based on reduction
in body weight in male rats in the interim sacrifice and increased incidences and severity of
cellular alterations in the parotid and submandibular glands in a 24-month chronic toxicity and
carcinogenicity study in rats. These NOAELS/LOAELS were further supported by the NOAEL
of 30 and LOAEL of 100 mg/kg bw/day in one-year studies in dogs. Standard uncertainty factors
of 10-fold for interspecies extrapolation and 10-fold for intraspecies variability were applied.
Therefore, the target Margin of Exposure (MOE) is 100.
Dermal Absorption
Based on a chemical-specific in vivo dermal absorption study, a dermal absorption factor of 4%
was determined for the exposure assessment of glyphosate.
3.4.2 Occupational Exposure and Risk Assessment
Workers can be exposed to glyphosate through mixing, loading, or applying the pesticide, and
when entering a treated site to conduct activities such as scouting.

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 Mixer, Loader, and Applicator Exposure and Risk Assessment
There are potential exposures to mixers, loaders and applicators. The following scenarios were
assessed:
•
•

•

Mixing/loading liquids.
Liquid groundboom, aerial, airblast, mechanically pressurized handgun, backpack, roller,
wick and other wiper implements, cut stump, right-of-way (ROW) sprayer, and injection
application to trees.
Injection application of pastes (pre-loaded cartridges) to trees.

Based on the number of applications and the timing of application, workers applying glyphosate
would generally have a short (< 30 days) duration of exposure. Custom applicators may also
have intermediate-term (in other words, up to several months) exposure for those crops with
multiple applications. Injection applications to trees can occur year-round (except when the barks
of trees are frozen), so exposure in these scenarios can be long-term.
Handler exposure was estimated based on the following personal protection:
Baseline PPE:

Long sleeved shirt, long pants and chemical-resistant gloves (unless
otherwise specified). For groundboom application, this scenario does not
include gloves as the data quality was better for non-gloved scenarios
than gloved scenarios.

Dermal and inhalation exposures were estimated using data from the Pesticide Handlers
Exposure Database (PHED), Version 1.1. The PHED is a compilation of generic mixer/loader
applicator passive dosimetry data with associated software that facilitates the generation of
scenario-specific exposure estimates based on formulation type, application equipment, mix/load
systems and level of personal protective equipment (PPE).
Glyphosate is registered for cut stump applications for which no PHED scenario exists. It was
assumed that exposure from mixing/loading and applying glyphosate by a manually pressurized
handwand would be comparable to the squirt bottle method used for cut stump applications.
Glyphosate is registered for tree injection applications for which no PHED scenario exists. For
this scenario, the mixing and loading (liquid) scenario was used to estimate exposure of
preparing the solution and loading the cartridges. Applicator exposure is expected to be minimal
as activities are conducted in a closed system. It was assumed that this scenario would be
protective of the preloaded paste cartridges scenario, as exposure during mixing and loading the
liquid solution would be higher.
Glyphosate is not applied by hose-end spray or low-pressure nozzle gun sprayer connected to
a truck. Therefore, these application equipment types were not assessed in the applicator risk
assessment.

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 Mixer/loader/applicator exposure estimates are based on the best available data at this time.
Route-specific MOEs for mixer/loader and applicators for agricultural crops, commercial and
recreational areas are outlined in Appendix VII, Tables 1 and 2. Calculated dermal, inhalation,
and combined (total exposure from dermal and inhalation routes) MOEs for mixer/loaders and
applicators of glyphosate exceeded target MOEs for all uses and are not of concern.
Postapplication Worker Exposure and Risk Assessment
The postapplication occupational risk assessment considered exposures to workers who enter
treated sites to conduct agronomic activities involving foliar contact (for example, scouting).
Based on the glyphosate use pattern, there is potential for short-term (< 30 days) postapplication
exposure to glyphosate residues for workers.
Activity-specific transfer coefficients (TCs) from the Agricultural Re-entry Task Force (ARTF)
were used to estimate postapplication exposure resulting from contact with treated turf and
foliage at various times after application. A TC is a factor that relates worker exposure to
dislodgeable residues. TCs are specific to a given crop and activity combination (for example,
hand harvesting apples, scouting late season corn) and reflect standard clothing worn by adult
workers. Postapplication exposure activities include (but are not limited to): scouting, weeding,
and transplanting.
As glyphosate is a non-selective herbicide, applications are usually made in the dormant season
or prior to planting. If application is required when the crop is developing, sprays are directed
between rows, and shields, wipers and rollers are used to prevent crop damage. In this case, it is
unlikely that there will be significant residues on the foliage of these crops to which workers
could come into contact when performing various postapplication activities. However, some
activities, such as scouting and irrigation, may result in contact with treated foliage. Therefore,
these postapplication activities were assessed.
Dislodgeable foliar residue (DFR) and turf transferrable residues (TTR) refer to the amount of
residue that can be dislodged or transferred from a surface, such as the leaves of a plant or
turf. There were no chemical-specific DFR or TTR studies submitted to the PMRA for the reevaluation of glyphosate; therefore the following defaults were used:
•
•

A default peak value of 25% of the application rate with a dissipation rate of 10% per day
was used for DFR.
A default peak value of 1% of the application rate with a dissipation rate of 10% per day
was used for TTR.

For workers entering a treated site, restricted entry intervals (REIs) are calculated to determine
the minimum length of time required before people can safely enter after application. An REI is
the duration of time that must elapse before residues decline to a level where performance of a
specific activity results in exposures above the target MOE.

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 The PMRA is primarily concerned with the potential for dermal exposure for workers
performing postapplication activities in crops treated with a foliar spray. Based on the vapour
pressure of glyphosate, inhalation exposure is not likely to be of concern provided that the
minimum 12-hour REI is followed.
Calculated dermal MOEs for worker postapplication exposure to glyphosate in commercial crops
exceeded target MOEs and are not of concern. REIs were set at the standard minimum value of
12 hours for all postapplication activities. The postapplication exposure assessment is outlined in
Appendix VII, Table 3.
3.4.3

Non-Occupational Exposure and Risk Assessment

Non-occupational risk assessment involves estimating risks to the general population, including
youth and children, during or after pesticide application.
The United States Environmental Protection Agency (USEPA) has generated standard
default assumptions for developing residential exposure assessments for both applicator and
postapplication exposures when chemical- and/or site-specific field data are limited. These
assumptions may be used in the absence of, or as a supplement to, chemical- and/or site-specific
data and generally result in high-end estimates of exposure. These assumptions are outlined in
the Standard Operating Procedures (SOPs) for Residential Pesticide Exposure Assessments
(2012). The following sections from the Residential SOPs were used to assess residential
exposure to glyphosate:
• Section 3: Lawns and Turf
• Section 4: Gardens and Trees
Residential Handler Exposure and Risk Assessment
A residential applicator would be an adult who purchased a domestic-class glyphosate product
for outdoor residential use.
Residential applicators are assumed to be wearing shorts, short-sleeved shirts, shoes and socks.
Based on label directions, domestic-class glyphosate products are assumed to be applied two
times per year (with a seven-day interval); therefore they would have potential for short-term
(1-30 days) exposure during application to lawns or turf.
Domestic-class glyphosate products are available in both liquid and tablet (water soluble)
formulations. For tablet formulations, the label instructs the handler to open the tablet packages
and, without touching the tablets, drop them directly into water to dissolve. This would result
in minimal handler exposure to the tablet itself. Thus, the tablet formulation was not assessed
separately, as it was assumed that the risk assessment for the liquid formulation, which has a
higher level of exposure, would be protective of exposure from the tablet formulation.

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 Based on the typical use pattern, the major scenarios identified were:
• mixing and loading liquids
• mixing and loading of water soluble tablets
• manually pressurized handwand, backpack and sprinkler (liquid) application to lawns and
turf and gardens and trees
• ready-to-use sprayer application to lawns and turf, and gardens and trees
Calculated dermal, inhalation, and combined (total exposure from dermal and inhalation routes)
MOEs for residential handler exposure to glyphosate exceeded target MOEs and are not of
concern. The residential handler risk assessment is outlined in Appendix VIII, Table 1.
Residential Postapplication Exposure and Risk Assessment
Residential postapplication exposure refers to an exposure scenario in which an individual is
exposed through dermal, inhalation, and/or incidental oral (non-dietary ingestion) routes as a
result of being in a residential environment that has been previously treated with a pesticide.
The area could have been treated by a residential applicator using a domestic-class product or a
commercial applicator hired to treat the residential area.
There is potential for short-term exposure to adults, youth (11 to < 16 years old), and children
(6 to < 11 years old and 1 to < 2 years old) through contact with transferable residues following
commercial applications of glyphosate to turf, as well as following domestic applications of
glyphosate to lawns and turf. Adults, youth and children have the potential for postapplication
dermal exposure; children (1 to < 2 years old) also have the potential for incidental oral
exposure. As the use rate of domestic class products is greater than the commercial use rate
for residential settings, the postapplication assessment for products applied by a residential
applicator is protective of the postapplication exposure to homeowners, youth and children after
a commercial application of glyphosate to turf.
The following scenarios were assessed for the postapplication exposure to glyphosate:
• Lawns and Turf
o Adults, youth, and children (1 to < 2 years old) dermal exposure resulting from
activities on turf
o Adult and youth dermal exposure resulting from mowing
o Adult, youth and children (6 to < 11 years old) dermal exposure resulting from
golfing
o Children (1 to < 2 years old) incidental oral exposure
As per label directions, glyphosate can be applied twice per year (with a seven-day interval).
This assumption was taken into consideration when determining postapplication risk.
The PMRA is primarily concerned with the potential for dermal exposure for homeowners
performing postapplication activities in treated residential areas. Non-dietary ingestion of soil
was not assessed as glyphosate becomes inactive once in the soil.

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 Postapplication dermal exposure using activity-specific TCs was calculated using estimates
for foliar residue, leaf-to-skin residue transfer for individuals contacting treated foliage during
certain activities, and exposure time. A TC is a factor that relates exposure to dislodgeable
residues. It is the amount of treated surface that a person contacts while performing activities
in a given period (usually expressed in units of cm2 per hour) and is specific to a particular
population.
For the residential postapplication assessment of glyphosate, transfer coefficients were derived in
the Residential SOPs for activities conducted on turf, such as mowing and golfing.
Calculated dermal MOEs for residential postapplication exposure, golf and incidental
oral exposure to glyphosate exceeded target MOEs and are not of concern. The residential
postapplication risk assessment is outlined in Appendix VIII, Tables 2-5.
Exposure to homeowners who apply glyphosate and conduct postapplication activities in treated
areas, along with potential dietary exposure, are considered in Section 3.5 – Aggregate Exposure
and Risk Assessment.
Dermal Bystander Exposure and Risk Assessment
There is potential for short-term exposure to glyphosate for adults, youth (11 to < 16 years old)
and children (6 to < 11 years old) by entry into treated non-cropland areas (in other words, hiking
through forests or parks that have recently been treated with glyphosate).
Calculated dermal MOEs for bystander exposure to glyphosate exceeded target MOEs and are
not of concern. Bystander exposure is outlined in Appendix VIII, Table 6.
3.5

Aggregate Exposure and Risk Assessment

Aggregate exposure is the total exposure to a single pesticide that may occur from food, drinking
water, residential and other non-occupational sources, and from all known or plausible exposure
routes (oral, dermal and inhalation).
3.5.1

Toxicology Endpoint Selection for Aggregate Risk Assessment

For aggregate risk assessment (all durations), the selected toxicological endpoint was the
effect on salivary glands. Salivary glands were not examined in the dermal toxicity studies and a
short-term inhalation study was not available. Effects on salivary glands could potentially result
from exposure to glyphosate via inhalation or dermal routes, similar to the effects observed
following oral exposure to glyphosate. Therefore, the most relevant study was the 26-month
chronic toxicity and carcinogenicity study in rats with a NOAEL of 32/34 mg/kg bw/day. This
was the highest (combined) NOAEL for the long-term toxicity studies in rats.

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 The lowest (combined) LOAEL was 100 mg/kg bw/day based on reduction in body weight in
male rats in the interim sacrifice and increased incidences and severity of cellular alterations in
the parotid and submandibular glands in a 24-month chronic toxicity and carcinogenicity study
in rats. Standard uncertainty factors of 10-fold for interspecies extrapolation and 10-fold for
intraspecies variability were applied. Therefore, the target Margin of Exposure (MOE) is 100.
3.5.2

Residential and Non-Occupational Aggregate Exposure and Risk Assessment

In an aggregate risk assessment, the combined potential risk associated with food, drinking water
and various residential exposure pathways is assessed. A major consideration is the likelihood of
co-occurences of exposure.
For glyphosate, the following scenarios that were expected to co-occur are:
• Inhalation and dermal exposure to homeowners (adults) applying glyphosate to lawns/turf
+ postapplication dermal exposure (adults) performing activities in treated areas +
chronic dietary (food and drinking water).
• Postapplication dermal exposure (youth and children [6 to < 11 years old]) from
performing postapplication activities in treated lawns/turf + chronic dietary (food and
drinking water).
• Postapplication dermal exposure (children 1 to < 2 years old) + incidental oral exposure
(hand-to-mouth) from performing postapplication activities in treated lawns/turf +
chronic dietary (food and drinking water).
When conducting the aggregate exposure assessment, two applications (with a seven-day
interval) at the highest rate were assumed. All calculated MOEs reached the target MOE except
for the children (1 to < 2 years old) for the postapplication + incidental oral exposure + chronic
dietary scenario. Therefore, dietary and non-dietary exposure refinements were required.
The dietary exposure assessment used United States Tolerances or Codex MRLs whenever they
happened to be greater than Canadian MRLs. However, domestic production and import
statistics indicated that barley, oats and wheat consumed in Canada are almost totally produced
in Canada (> 99%), with < 1% imported. Thus it was considered reasonable to use Canadian
MRLs for these crops as a refinement in the calculation of the chronic dietary exposure estimates
for the purpose of aggregation with residential exposure only, rather than the United States and
Codex group tolerance of 30 ppm. The current Canadian MRLs in these cereal crops are as
follows: barley (and barley flour) – 10 ppm, barley milling fractions (except flour) – 15 ppm, oat
(and oat flour) – 15 ppm, oat milling fractions (except flour) – 35 ppm, wheat (and wheat flour) –
5 ppm, and wheat milling fraction (except flour) – 15 ppm.
In addition, assuming two applications (with a seven-day interval) at the maximum application
rate is a highly conservative exposure assumption, as it is unlikely that children would be
exposed to turf residues of the highest rate, at the lowest interval of application immediately after
application. Therefore, a refinement using one application of glyphosate along with a seven-day
time-weighted TTR average was used (the average resides of glyphosate were calculated over a
seven-day span) for the entire aggregate assessment for all populations.

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 Using these refinements, all calculated MOEs exceeded the target MOE and are not of concern.
The aggregate exposure estimates from residential scenarios are presented in Appendix IX,
Table 1.
3.6

Polyethoxylated Tallow Amines

Polyethoxylated tallow amines (POEA) is a family of several compounds that are used as
surfactants in many glyphosate products registered in Canada. In 2010, the USEPA completed
a human health risk assessment for phosphate ester, tallowamine, ethoxylated (ATAE), which
is a subfamily of POEA (PMRA #2439855). The USEPA currently uses this assessment as the
basis for the approval of POEA. The USEPA assessment is considered to be applicable to
the Canadian exposure profile and can be relied upon by PMRA to evaluate POEA risks. This
assessment was considered acceptable by the PMRA.
The USEPA ATAE assessment was based on very conservative assumptions (for example,
all crops treated at 100%, highest application rates and default values). Since exposures
from all pesticidal sources of POEA need to be considered, the potential occupational,
non-occupational and aggregate exposures from 57 highly used herbicides, fungicides and
insecticides were evaluated. Given this approach, the POEA risk assessment and conclusions
apply broadly to all pesticide products.
No risks of concern were identified, provided end-use products contained no more than
20% POEA by weight. All of the currently registered glyphosate end-use products in Canada
meet this limit.
In addition, no new toxicity data relevant to the hazard assessment of POEA were found
following a search of the published scientific literature beyond that identified in the USEPA
ATAE health risk assessment. As such, an updated risk assessment was not required.
3.7

Incident Reports Related to Human Health

Since 26 April 2007, registrants have been legally required to report incidents to the PMRA that
include adverse effects to the health of Canadians and to the environment. Information about the
reporting of pesticide incidents can be found on the PMRA website. Incident reports were
searched and reviewed for the active ingredient glyphosate. As of January 2014, the PMRA had
received 71 human and 167 domestic animal incident reports involving glyphosate.
A total of 75 individuals were affected in the human incidents. In almost half of these incidents,
the described effects were considered to be associated with the reported pesticide exposure.
Major incident reports involving glyphosate occurred mainly in the United States as a result of
accidental ingestion. Other highly acutely toxic active ingredients (such as diquat and paraquat)
were also noted in these incidents. Therefore, any adverse effects could not be attributed
specifically to glyphosate. Non-serious incidents, which included a prevalence of eye and skin
irritation effects, occurred as a result of activities associated with application. Commercial class
products were frequently identified in these incidents.

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 The domestic animal incidents involving glyphosate were mostly animal deaths that occurred
in the United States. Overall, the reported symptoms in animals were clinical signs of
toxicity such as vomiting. Contact with a treated area and ingestion of vegetation treated with a
product containing glyphosate were commonly noted as activities leading to exposure in animal
incidents.
No label changes resulting from these incident reports are considered necessary at this time.

4.0

Impact on the Environment

The environmental assessment was conducted based on data and information from registrants as
well as from other regulatory agencies. Additional relevant data from published and unpublished
scientific literature and monitoring data from federal and provincial governments were also
considered.
4.1

Fate and Behaviour in the Environment

The fate and behaviour data for glyphosate and its transformation products in terrestrial and
aquatic environments are presented in Appendix X, Tables X.1 and X.2.
Glyphosate enters the terrestrial environment when it is used as a herbicide in agriculture,
forestry (site preparation) and non-cropland (right of ways and industrial sites). In the terrestrial
environment, glyphosate is expected to be non-persistent to moderately persistent in aerobic soil
(DT50 1.9-151 d), producing the major soil biotransformation product AMPA. Under anaerobic
conditions (flooded soil), glyphosate is more readily bound to soil and less readily transformed.
Phototransformation is not expected to be an important route of dissipation.
Glyphosate has a low vapour pressure (1.3 × 10-7 Pa at 25ºC) and a low Henry’s law constant
(2.1 × 10-9 Pa m3) and is not expected to volatilize under field conditions from water or moist
soil. Glyphosate is very soluble in water (12 000 mg a.e./L). Under Canadian field conditions
(agriculture and forestry), glyphosate generally remains in the upper soil horizons and is
considered to be non-persistent to moderately persistent (DT50 ranging from 6 to 82 days).
Adsorption/desorption studies, soil column leaching studies, soil thin layer chromatography
(TLC) studies, ground water modelling, as well the criteria of Cohen et al. (1984) and the
groundwater ubiquity score (GUS) all indicate that glyphosate has low mobility in soil, remains
in the upper soil horizon and has a low potential to leach to groundwater. Detection of
glyphosate in lower structured soil horizons (loams and clay loams) by several researchers is
believed to be the result of preferential flow through macropores. Glyphosate is rarely detected
in known drinking water sources and groundwater in Canada, further supporting the conclusion
that glyphosate is unlikely to contaminate groundwater. In terrestrial environments, AMPA is
produced mainly through soil biotransformation and is non-persistent to moderately persistent
(DT50 2.1 to 107 days).

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 Glyphosate can enter aquatic environments through spray drift and runoff from the application
site. Aerobic aquatic studies indicate that glyphosate dissipates rapidly from the water phase and
partitions to sediment where transformation occurs more slowly (whole system DT50 7.1 to
135 days). AMPA is the major transformation product produced. Hydrolysis (DT50 at 25ºC and
pH 7 was estimated to be >162 days) and aquatic phototransformation (DT50 69 to 413 days at
pH 7) of glyphosate are not important routes of dissipation. Under anaerobic conditions,
glyphosate was non-persistent to persistent (DT50 7 to 208 days).
In aerobic aquatic environments, AMPA is found in both water and sediment and is nonpersistent to moderately persistent (total system DT50 10 to 83.4 days). In the water column,
AMPA partitions to the sediment where it is further transformed to CO2.
The surfactant POEA is expected to be non-volatile, non-persistent in soil and water and
immobile in soil and sediment. It is not likely to leach to groundwater due to rapid microbial
transformation and strong adsorption to soil particles.
Glyphosate and AMPA are not expected to bioaccumulate in aquatic and terrestrial organisms
due to their low octanol-water partition coefficients. Certain surfactants found in glyphosate
formulations, that are derived from POEA compounds (mixture of 100 discrete tertiary amine
molecules) may have the potential for bioaccumulation. However, given that the components of
these compounds are easily broken down and that they are not persistent in soil and water,
significant bioaccumulation under field conditions is unlikely.
4.2

Environmental Risk Characterization

The environmental risk assessment integrates the environmental exposure and ecotoxicology
information to estimate the potential for adverse effects on non-target species. This integration is
achieved by comparing exposure concentrations with concentrations at which adverse effects
occur. EECs are concentrations of pesticide in various environmental media, such as food, water,
soil and air. The EECs are estimated using standard models which take into consideration the
application rate(s), chemical properties and environmental fate properties, including the
dissipation of the pesticide between applications. EECs are presented in Appendix X, Tables X.3
to X.7. Ecotoxicology information includes acute and chronic toxicity data for various organisms
or groups of organisms from both terrestrial and aquatic habitats including invertebrates,
vertebrates and plants. Toxicity endpoints used in risk assessments may be adjusted to account
for potential differences in species sensitivity as well as varying protection goals (in other words,
protection at the community, population, or individual level). Summaries of toxicity data for both
terrestrial and aquatic non-target organisms to glyphosate are presented in Appendix X,
Tables X.8 to X.16.
Initially, a screening level risk assessment is performed to identify pesticides and/or specific uses
that do not pose a risk to non-target organisms, and to identify those groups of organisms for
which there may be a potential risk. The screening level risk assessment uses simple methods,
conservative exposure scenarios (for example, direct application at a maximum cumulative
application rate) and sensitive toxicity endpoints. A risk quotient (RQ) is calculated by dividing
the exposure estimate by an appropriate toxicity value (RQ = exposure/toxicity), and the risk
Proposed Re-evaluation Decision – PRVD2015-01
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 quotient is then compared to the level of concern (LOC). If the screening level risk quotient is
below the level of concern, the risk is considered negligible and no further risk characterization
is necessary. If the screening level risk quotient is equal to or greater than the level of concern,
then a refined risk assessment is performed to further characterize the risk. A refined assessment
takes into consideration more realistic exposure scenarios (such as drift to non-target habitats)
and might consider different toxicity endpoints. Refinements may include further
characterization of risk based on exposure modelling, monitoring data (Appendix XI), results
from field or mesocosm studies, and probabilistic risk assessment methods. Refinements to the
risk assessment may continue until the risk is adequately characterized or no further refinements
are possible. Data derived from monitoring studies may also be used in refining a risk
assessment.
Where possible the analysis of toxicity data also includes the determination of the hazardous
concentration to five percent of species (HC5) from species sensitivity distributions (SSDs) or
determination of the most sensitive endpoint in each taxonomic group and category. The HC5
is calculated for acute and chronic data sets using the LC50/EC50 values and no observed effect
concentration (NOEC) values as appropriate (EC25 was also used for terrestrial plants when no
other data was available). The HC5 is the concentration that is assumed to be protective for
ninety-five percent of species of the assessed taxonomic group or assemblage as related
to the assessment endpoint and ecological protection goal. At an EEC equal to the HC5,
ninety-five percent of all species (within each taxonomic group) are not expected to be exposed
to concentrations exceeding their threshold toxicity value (for example, LC50, NOEC).
The software program ETX 2.0 was used with a log-logistic model to generate SSDs where
sufficient toxicity endpoints were available for different taxa, using all available relevant
information on toxicity. This reduces the uncertainty in risk estimates and provides endpoints
that are scientifically robust as compared to single species toxicity test endpoints, as well as
returning endpoints that are more ecologically relevant as compared to relying on the most
sensitive species available. Median HC5 values are reported for SSDs and where possible are
used to determine risk and mitigation measures. The variability in the data sets is indicated by
the upper and lower bound HC5 estimates and the confidence limit of the fraction of species
affected, which indicates the minimum and maximum percent of species that could be affected
when exposed to the HC5 concentration.
Where an HC5 value could not be determined due to insufficient species numbers or lack of
model fit, etc., the most sensitive species endpoint was reported with the use of appropriate
uncertainty factors. Where multiple data points are available for one species, a geometric
mean was used to represent the sensitivity of the species. SSDs were determined for different
glyphosate formulations, the transformation product AMPA and the formulant POEA for the
following taxonomic groups (results are reported in Appendix X, Table X.17).
•
•
•

Terrestrial plants
Freshwater invertebrates, fish, algae, amphibians and aquatic plants
Marine fish, invertebrates and algae

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 4.2.1

Risks to Terrestrial Organisms

Certain glyphosate formulations include the surfactant POEA, which has been shown to be toxic
to aquatic organisms under laboratory conditions. For the environmental risk assessment, the
technical grade active ingredient, transformation product AMPA, POEA and formulated end-use
products were evaluated. Results for formulated end-use products were categorized into those
products that contain POEA, those that do not and those for which information was not available
to determine if they included POEA or not.
Summaries of the toxicity data considered in this review are presented in Appendix X,
Tables X.8 to X.16. For the assessment of risk, toxicity endpoints chosen from the most sensitive
species or obtained from the SSD were used as surrogates for the wide range of species that can
be potentially exposed following treatment with glyphosate. The terrestrial assessment took into
account the range of agricultural application rates that are registered for glyphosate, taking into
consideration that there may be multiple applications of glyphosate in a single-use season.
All data sets were grouped by test material type including technical grade active ingredient
(technical grade active ingredient, includes all forms of glyphosate actives), end-use products
containing the surfactant POEA (EUP + POEA), end-use products that do not contain POEA
(EUP NO POEA), POEA alone and the glyphosate transformation product AMPA. All toxicity
values were normalized to acid equivalent (a.e.).
Terrestrial Invertebrates
Earthworms, Soil Beneficial Insects, Bees, Predators and Parasitic Arthropods
Acute and chronic studies indicate that glyphosate is not toxic to earthworms and the resulting
risk quotients based on the maximum application rate indicate that glyphosate is not expected to
pose a risk to earthworms (Appendix X, Table X.18). A risk to the soil beneficial arthropod
Folsomia candida was observed at the screening level (from in-field treatment), but refinement
of the risk assessment based on drift including a soil deposition factor and also on field studies
from scientific publications (not reported in tables) indicated arthropod populations would
recover from exposure to glyphosate applied at the maximum rate in apple orchards and canola
fields (Appendix X, Table X.18).
Glyphosate is not acutely toxic (contact and oral) to adult bees and risk quotients indicate that
glyphosate is not expected to pose a risk to adult bees (Appendix X, Table X.19). Chronic bee
toxicity studies were not available for review; however, chronic effects are not expected based
on the mode of action and the lack of effects in acute toxicity studies with adult bees (no
sublethal effects or mortality at the highest test concentrations). Data on larval and brood toxicity
were not available for review, however risks are not expected based on limited exposure (due to
the mode of action of glyphosate), a lack of effects observed on adult bees and the lack of
significant effects on other immature insects (chironomids and beneficial arthropods). This
evidence, in combination with the absence of bee incident reports associated with the long
history of use in Canada and foreign countries, indicates that glyphosate is unlikely to pose
significant risks to honeybees for the proposed use pattern.
Proposed Re-evaluation Decision – PRVD2015-01
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 Under laboratory conditions, acute and chronic risks to predatory and parasitic arthropods
were observed at the screening level (considering results from glass plate studies with both
Typhlodromus pyri and Aphidius rhopalosiphi). Risk quotients also slightly exceeded the level
of concern for T. pyri when considering results of extended laboratory conditions (leaf substrate)
for apple, canola and potato uses (T. pyri, RQs = 1.9, 1.8 and 1.1 for apple, canola and potato
uses, respectively). Refinement of the risk assessment and comparison with results obtained for
other beneficial arthropods in recent scientific publications indicated that predator and parasitic
arthropod populations would recover from exposure to glyphosate at the maximum rate of
application in apple orchard and canola fields, respectively (7285 g a.e./ha and 6990 g a.e./ha)
(Appendix X, Table X.19).
Risk to Birds
A tiered assessment of the risks to birds progressing from a conservative screening assessment to
a more refined assessment was conducted. In the vast majority of studies, no toxic effects were
reported. Consequently, a very conservative assessment was conducted using risk quotients
generated using the highest concentration tested even though in all but one case, no toxic effects
were observed. This assessment found only very small exceedences of the LOC and concluded
that the risk to birds from acute oral, dietary and reproduction exposure to glyphosate and its
formulations is expected to be low.
The screening level risk quotients based on acute oral exposure of birds to glyphosate technical
may slightly exceed the level of concern for small- and medium-sized birds (RQ < 1.9 and
< 1.5 for small- and medium-sized birds, respectively). However, this is based on the maximum
concentration tested and no adverse effects were observed. The screening level risk quotients for
reproduction also slightly exceed the level of concern for all sizes of birds (RQs range from
1.0 to 2.0) (Appendix X, Table X.20). Risks were further characterized by expanding the scope
of the assessment to include other guilds, dietary exposure, mean residue levels and off-field
exposure. Note that the acute oral LD50 and dietary LD50 values are greater than the highest
doses tested, and the reproduction NOELs are the highest doses tested. Thus, the risk quotients
are very conservative and may not reflect a true concern.
Based on the crop and the type of equipment used, spray drift factors were applied to the in-field
exposure values to obtain off-field exposure values. The product label specifies that the spray
droplets must be at least coarse, based on the American Society of Agricultural Engineers
(ASAE) classification. Consistent with the use pattern for apples considered in this assessment,
for a coarse droplet size, the maximum spray drift deposition at one metre downwind from the
point of application is 3% of the rate for field sprayer application to agricultural crops. In the
refined assessment, risk quotients slightly exceed the level of concern for on-field exposure of
small and medium insectivorous birds on an acute, dietary and reproduction basis (maximum and
mean residues), and large herbivores on a dietary and reproduction basis (maximum residues
only) (Appendix X, Table X.21).

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 For these groups, the risk quotients exceed the level of concern by only a small margin and most
are “less than” values, which means that the level of concern may not actually be exceeded. The
risk quotients for off-field exposure do not exceed the level of concern. It should be noted that
none of the toxicity studies conducted with technical glyphosate resulted in measured toxic
effects in birds.
Screening-level estimated dietary exposure (EDE) values and RQ calculations for birds exposed
to single applications of glyphosate formulations are presented in Appendix X, Table X.22.
Based on acute oral exposure to glyphosate formulations, the screening level risk quotients
exceed the level of concern for all sizes of birds (RQ = 1.6 to 3.1). The risk to birds from
exposure to glyphosate formulations was further characterized by expanding the scope of the
assessment to include other guilds, dietary exposure, mean residue levels as well as off-field
exposure. In the refined risk assessment, for acute oral exposure of birds to glyphosate
formulations, risk quotients exceed only the level of concern for small and medium insectivores
(maximum residues RQ = 2.4 to 3.1, mean residue RQ = 1.7 to 2.2), and large herbivores
(maximum residue RQ = 1.5 to 1.6) (Appendix X, Table 23). None of the dietary toxicity studies
conducted with glyphosate formulations resulted in measured toxic effects in birds (the dietary
LD50 values are greater than the highest doses tested), resulting in risk quotients for dietary
exposure of birds to glyphosate formulations all having less than values (maximum residues
RQ < 18.8 to < 0.7 and mean residues RQ < 13 to < 0.6) (Appendix X, Table X.23). The toxicity
endpoints and associated risk quotients for dietary exposure are very conservative as they are
based on an absence of effects.
Bird toxicity studies indicate that acute oral exposure (gavage) to glyphosate formulations can
result in effects (and some risk quotients exceeding the level of concern). However, dietary
studies, which are more representative of the potential route of exposure in the environment (in
other words, through contaminated food items) reported that no toxic effects were observed with
exposure to dried residues of the formulation in the diet. The predominant route of exposure will
be from ingestion of dried residues on food items. It should be noted, however, that exposure to
the sprayed formulation, which could occur via preening if birds are sprayed directly or through
spray drift, was not considered in this assessment. Thus, more weight is given to conclusions of
the dietary assessment than to the acute oral assessment. Therefore, the risk to birds from acute
oral, dietary and reproduction exposure to glyphosate and its formulations is expected to be
low. The absence of incident reports for birds related to the use of glyphosate supports this
conclusion. Bird hazard statements are not required on glyphosate product labels.
Risk to Mammals
Toxic effects were reported in only a few of the available studies conducted with mammals and
these effects were observed only at very high doses. A tiered assessment of the risks to mammals
progressing from a conservative screening assessment to a more refined assessment was
conducted. This assessment found only very small exceedences of the LOC and concluded that
the risk to mammals from acute oral and reproduction exposure to glyphosate and its
formulations is expected to be low.

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 Screening level risk quotients exceed the level of concern for all sizes of mammals for acute
oral exposure to glyphosate technical (RQ = 2.2 to 4.2) but did not exceed the level of concern
for reproduction (RQ ≤ 0.9) (Appendix X, Table X.20). The risk to mammals from exposure to
glyphosate technical was further characterized by expanding the scope of the assessment to
include other guilds, dietary exposure, mean residue levels, off-field exposure as well as other
endpoints. Eighteen acute oral glyphosate technical toxicity studies were available for mammals.
Whereas a few studies measured effects at high doses, the majority indicated LD50 values greater
than the highest dose tested. Based on the most sensitive endpoint for acute oral exposure, the
risk quotients exceed the level of concern for on-field exposure of small insectivorous mammals
when considering maximum (RQ = 2.2) and mean (RQ = 1.5) residues, medium-sized
insectivorous and herbivorous mammals when considering maximum and mean residues
(maximum residue RQ = 1.9 to 4.2 and mean residue RQ = 1.3 to 1.5) and large-sized
insectivorous and herbivorous mammals when considering maximum residues only (RQ = 1.0 to
2.3) (Appendix I, Table ). No risk quotients exceed the level of concern for off-field exposure.
Given the range of toxicity values available, risk quotients were also calculated using the least
sensitive acute oral endpoint for mammals. Based on an acute oral LD50 of 5600 mg/kg bw, risk
quotients very slightly exceed the level of concern for on-field exposure of medium-sized
herbivorous mammals exposed to maximum residues of glyphosate (RQ = 1.2) (Appendix X,
Table X.24).
Screening level acute oral exposure RQ values for glyphosate formulations exceed the level of
concern for all sizes mammals (RQ = 5.7 to 11) (Appendix X, Table X.22). The risk to mammals
from exposure to glyphosate formulations was further characterized by expanding the scope of
the assessment to include other guilds, mean residue levels, off-field exposure as well as other
endpoints. Fifty acute oral toxicity studies (based only on three distinct species) with glyphosate
formulations were available for mammals. Eight of these studies measured effects at high doses,
but the majority indicated LD50 values greater than the highest dose tested. Based on the most
sensitive endpoint for acute oral exposure, the risk quotients exceed the level of concern for
on field exposure of insectivorous and herbivorous mammals of all sizes (maximum residue RQ
= 2.6 to 11, mean residue RQ = 1.2 to 3.9), and small and medium-sized frugivores (maximum
residue RQ = 1.5 to 1.8) (Appendix I). Risk quotients for off-field exposure did not exceed the
level of concern. Risk quotients were also calculated using the least sensitive acute oral endpoint.
Based on an acute oral LD50 of > 4000 mg/kg bw, risk quotients do not exceed the level of
concern for mammals of any size (RQs ≤ 0.5) (Appendix X, Table X.25).
Overall, available data indicate that risks to mammals following acute oral exposure to
glyphosate and its formulations are low. If any, acute risks to mammals would be restricted to
on-field exposure of only a few guilds (herbivores and perhaps insectivores). No reproductive
risks to mammals are expected from the use of glyphosate. This conclusion is supported by the
absence of incident reports for mammals related to the use of glyphosate. Mammalian hazard
statements are not required on glyphosate product labels.

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 Risk to Non-target Terrestrial Plants
Glyphosate is a broad spectrum herbicide and as such toxicity to susceptible non-target plants is
expected if exposed to sufficiently high concentration. The risk assessment for non-target
terrestrial plants identified some areas of potential risk and consequently measures to minimize
exposure to non-target plants are required.
Based on EECs equal to the maximum cumulative application rates for the uses on apples,
canola, corn and potatoes and the toxicity endpoints selected for seedling emergence (the most
sensitive EC50) and vegetative vigour (the EC50 for formulation without POEA and HC5 of SSDs
for formulations with POEA), all screening level risk quotients exceed the level of concern
(Appendix X, Table X.26). The most sensitive terrestrial plant endpoint is the EC50 value of
0.014 kg a.e./ha for the end-use product without POEA based on vegetative vigour. Cumulative
application rates were calculated using a soil DT50 of 32.6 days for seedling emergence and a
foliar DT50 of 14.4 days for vegetative vigour, to account for dissipation between applications.
The risk to terrestrial vascular plants was further characterized by looking at off-field exposure
from drift.
For an ASAE coarse droplet size, the maximum spray drift deposition at one metre downwind
from the point of application is 3% of the application rate for field sprayer application to
agricultural crops and 17% for aerial application. Aerial application is registered for use on
canola (pre-harvest), but not on apples, corn or potatoes. Based on the risk quotients using the
off-field EECs from drift, the level of concern for terrestrial vascular plants is not exceeded for
seedling emergence, but is exceeded for vegetative vigour in all cases, except for the use of
formulations without POEA on potatoes (Appendix X, Table X.26).
To protect non-target terrestrial vascular plants, spray buffer zones are required on glyphosate
product labels, both those with and without the surfactant POEA (Appendix XII).
Transformation Product (AMPA)
Earthworms and birds were the only terrestrial organisms tested with the transformation product
AMPA. The screening level risk quotients for acute and chronic exposure did not exceed the
level of concern. Since AMPA is mainly formed in soils through biological processes, has a low
log Kow (-2.36 to -1.63) and binds tightly to soil particles, exposure and risk to mammals and
foliage dwelling arthropods is expected to be negligible. To date, no ecotoxicological incidents
have been reported concerning AMPA. As such no additional studies are required at this time.
Endocrine Disruption
The USEPA Endocrine Disruptor Screening Program (EDSP) is a scientific program to screen
pesticides, other chemicals, and environmental contaminants for substances having the potential
to affect the estrogen, androgen or thyroid hormone systems. Glyphosate was included in the
second EDSP List. The PMRA will consider the results of these screening tests as they become
available.

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 4.2.2

Risks to Aquatic Organisms

Glyphosate can enter water bodies and expose non-target aquatic organisms through runoff
or via spray drift. The aquatic risk assessment was conducted following a tiered approach with
a very conservative screening assessment followed by refinements if concerns were identified
at the screening level. Overall there are few risks of concerns for aquatic organisms with the
exception of aquatic plants and some marine invertebrates and these areas of concern were
mainly identified with formulations containing the surfactant POEA.
Summaries of the aquatic toxicity data considered in this review are presented in Appendix X,
Table 27. The most sensitive aquatic taxonomic group is freshwater plants and the acute HC5
value is 0.003 mg a.e./L for the EUP + POEA formulation. The order of species sensitivity
was determined to be: freshwater plants (0.003 mg a.e./L) > marine fish and invertebrates
(0.1 mg a.e./L) > freshwater algae (0.12 mg a.e./L) > freshwater invertebrates (0.19 mg a.e./L)
> marine algae (0.33 mg a.e./L) > freshwater fish (0.36 mg a.e./L), and amphibians (0.86 mg
a.e./L) (Appendix X, Table X.17).
Screening level risk quotients for all freshwater organisms that were tested with end-use products
containing POEA following acute and/or chronic exposures were all above the level of concern.
All tested glyphosate formulations that do not contain POEA had risk quotients below the level
of concern, except for freshwater algae. Saltwater invertebrates (acute exposure) and algae
(chronic exposure) exposed to glyphosate formulation containing POEA had risk quotients above
the level of concern. The surfactant POEA tested alone had risk quotients above the level of
concern for freshwater and marine/estuarine invertebrates and freshwater fish, confirming the
international scientific consensus that POEA added to glyphosate increases the environmental
risk to these organisms.
The transformation product AMPA is not toxic to aquatic organisms.
Refined Risk Assessment for Aquatic Organisms and Potential Risk from Drift
The risk to aquatic organisms was further characterized by taking into consideration the
concentrations of glyphosate that could be deposited in off-field aquatic habitats that are
downwind and directly adjacent to the treated field through drift of spray. The spray drift data of
Wolf and Caldwell (2001) was used to determine the maximum spray deposit into an aquatic
habitat located one metre downwind from a treated field. Review of the labels for glyphosate
containing end-use products indicate that the end-use products are applied by ground and aerial
application methods. The maximum percentage of the applied spray that is expected to drift 1m
downwind from the application site during spraying using field sprayer and aerial application
methods is determined based on a coarse spray droplet size: field sprayer – 3%, aerial – 17%,
respectively. Given the variation in percent drift off site for each of the application methods, the
assessment of potential risk from drift was done using the maximum single application for potato
(groundboom application: 4320 g a.e./ha) and the maximum cumulative application rate for
canola (aerial application: 4320 + 4320 + 902 at 10-day intervals g a.e./ha). The EECs resulting
from drift for these two crops cover the full range of EECs from drift anticipated from all
application rates and application methods.
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 For freshwater snails, freshwater and saltwater fish and saltwater algae, the risk quotients, after
refinement, were below the level of concern.
For freshwater invertebrates, the risk quotients derived for acute exposure to spray drift from the
surfactant POEA alone exceeded the level of concern (RQ = 1.8 – 16.1). Based on acute toxicity
endpoints (HC5) derived for POEA containing glyphosate formulations, the level of concern is
slightly exceeded at the highest cummulative aerial application rate (RQ = 1.1).
For freshwater plants and marine/estuarine invertebrates, the level of concern is exceeded
for acute effects at all application rates and for all application methods (freshwater plants
RQ = 6.7 to 67 and marine/estuarine invertebrate RQ = 2 to 20), with the risk quotients being
based on the toxicity to glyphosate formulations that contain POEA. Based on glyphosate
formulations that do not contain POEA, the level of concern for acute effects is exceeded for
freshwater algae at the highest application rate (RQ = 3.3).
Based on amphibian laboratory toxicity data, the level of concern is slightly exceeded for
amphibians exposed to spray drift from glyphosate formulations containing POEA at the highest
cumulative aerial application rate on an acute and chronic basis (acute RQ = 1.1, chronic
RQ = 1.2), however the level of concern for acute and chronic effects is not exceeded when
amphibian toxicity data derived from field and mesocosm level studies are considered
(Appendix X, Table X.28).
To protect aquatic species, spray buffer zones are required on glyphosate product labels, both
those with and without the surfactant POEA.
Assessment of Potential Risk from Runoff
Aquatic organisms can also be exposed to glyphosate applied to foliage as a result of runoff into
a body of water. The linked models Pesticide Root Zone Model (PRZM) and Exposure Analysis
Modeling System (EXAMS) were used to predict EECs resulting from runoff of glyphosate
following application. Considering the crop uses and geographic crop distribution, as well as the
available scenarios, nine standard regional scenarios were modelled to represent different regions
of Canada. The Level 1 glyphosate EECs in a 1-ha receiving water body (15 and 80 cm deep)
predicted by PRZM-EXAMS for these crops applications are presented in Tables XI.3-5,
Appendix XI. The values reported by PRZM/EXAMS are 90th percentile concentrations of the
concentrations determined at a number of time-frames including the yearly peak, 96-hr, 21-d,
60-d, 90-d and yearly average.
Acute and chronic risk quotient values were calculated using an EEC for the time frame that
most closely matched the exposure time used to generate the endpoint. For example, a 96-hour
LC50 would use the 96-hour value generated by the model; a 21-day NOEC would use the 21-day
EEC value. At the screening level, RQ values for organisms (acute and/or chronic exposure)
exceeded the level of concern. The EECs used for calculation of the RQs were the highest values
for the appropriate depth and appropriate time frame (in other words, potato-use scenario in
Prince Edward Island); when the RQ based on the highest EEC exceeded the level of concern, an
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 RQ based on the lowest EEC values (apple-use scenario in British Columbia) was also
calculated. Screening level acute and chronic RQ values for freshwater and marine organisms are
reported in Appendix X, Table X.27.
Refinement was done for runoff, with all endpoints being based on exposure to glyphosate
formulations containing POEA, unless otherwise indicated.
The risk quotients for runoff derived for acute exposure exceed the level of concern for
freshwater algae and marine invertebrates (freshwater algae RQ = 1.6, marine invertebrates RQ =
9.6) at the highest EECs (potato-use scenario in Prince Edward Island), but not at the lowest
EECs (apple-use scenario in British Columbia). The risk quotients derived for chronic exposure
indicate that the level of concern is exceeded for freshwater aquatic plants (RQ = 26) at the
highest EECs (potato-use scenario in Prince Edward Island), but not at the lowest EECs (appleuse scenario in British Columbia) (Appendix X, Table X.29).
Refinement with Monitoring Data
The risk assessment was refined by considering all available Canadian monitoring data. A
summary of water monitoring data is presented in Appendix XI. An EEC of 40.8 ug/L (the
highest detection of glyphosate in surface water) was used for the refined risk assessment. Risk
quotients were calculated for organisms (acute and/or chronic exposure) that showed exceedence
of the level of concern at the screening level. The refined RQ values (Appendix X, Table X.30)
indicate that the level of concern not exceeded for aquatic organisms with the exception of
freshwater plants (RQ = 14).
Label statements are specified to help reduce runoff to aquatic habitats.
4.2.3

Incident Reports Related to the Environment

Since 26 April 2007, registrants have been required by law to report incidents to the PMRA that
include adverse effects to Canadian health or the environment. Information about the reporting
of pesticide incidents can be found on the PMRA website. Incident reports involving all
forms of the active ingredient glyphosate were reviewed. As of 10 May 2013, there were
37 environmental incident reports in the PMRA database involving a form of the active
ingredient glyphosate (PMRA# 2304789 and 2310009).
There were three major environmental incidents in which fish were killed when water used to
douse a chemical warehouse fire was released into a stream. It was unclear which chemical may
have been responsible for the fish mortality.
The remaining incidents were minor in nature and mostly involved grass damage following
the direct application of a glyphosate product. There were six minor non-grass incidents that
occurred following the drift of a glyphosate product onto non-target plants. Overall, there was a
high degree of association between the reported environmental exposure to glyphosate and the
effects observed.

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 Table 4.1

Minor Incidents Listed by Type of Organism Affected and Causality Level

Organism
Highly Probable Probable
Grass/Lawn
19
6
Herbaceous Plants
3
2
Trees or shrubs
1
2
Total
23
10
1

Possible
—
—
1
1

Unlikely
—
2
—
2

Total
25
7
4
361

One incident reported damage to onions (herbaceous plant) and two different types of trees. The total count of
incidents by organism type (36) is therefore higher than the number of minor incident reports received.

The USEPA Ecological Incident Information System (EIIS) was also queried for glyphosate
incidents that were available in the database as of 29 November 2012. There were 633 incident
reports available in the EIIS database that involved glyphosate (116 incidents), glyphosate
isopropylamine salt (516 cases) or glyphosate potassium salt (1 case). The most frequently
reported site/crop affected was agricultural area (139 incidents), cotton (51 incidents), corn
(36 incidents), soybean (27 incidents), and home/lawn (26 incidents). Plant damage (449 cases)
and mortality (171 cases) were the most frequently reported symptoms. Of the 633 reports,
nearly half were considered to be related to the misuse of a product (48%) and 95% were
considered to have a certainty of at least possible (180 possible, 352 probable and 42 highly
probable). 54% of all reports were the result of drift, while 23% were treated directly.
All the information stated above was considered in this evaluation and did not affect the risk
assessment.

5.0

Value

5.1

Value of Glyphosate

Glyphosate plays an important role in Canadian weed management in both agricultural
production and non-agricultural land management and is the most widely used herbicide in
Canada.
Value to Canadian Agriculture
Glyphosate is an important herbicide for Canadian agriculture:
• Due to its broad and flexible use pattern and its wide weed control spectrum, it is the
most widely used herbicide in several major crops grown in Canada such as canola,
soybean, field corn and wheat. It is also one of only a few herbicides regularly used in
fruit orchards such as apple.
• It is the essential herbicide for use on the glyphosate tolerant crops (GTCs) including
canola, soybean, corn, sweet corn and sugar beet. The combination of GTCs and
glyphosate has been adopted as an important and common agricultural production
practice in Canada.

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 •

•
•
•

•

It is identified by growers (in the Canadian Grower Priority Database [version 22, August
2011]) as a priority for 17 new uses relating to 17 commodities: almond, bluegrass,
kentucky bluegrass, bromegrass, canary seed, creeping red fescue, fescue, bermuda grass,
pearl millet (grain), orchard grass, peanut, pecan, ryegrass, soybean, sunflower, timothy
and wheatgrass.
Among all herbicides registered, glyphosate has the broadest range of use sites because it
can be used on all crops when applied prior to planting. In addition, it has the widest
weed control spectrum including annual and perennial weeds, weedy trees and brush.
Compared to other non-selective herbicides, it controls weeds of various sizes as well as
the roots of these weeds since glyphosate is translocated throughout the plant.
Glyphosate can be tank-mixed with many residual herbicides to broaden the weed
spectrum and extend the duration of weed control thus decreasing the number of
herbicide applications while maximizing yield and lowering fuel and energy
consumption.
Glyphosate has a wide application window including pre-seeding, after seeding (prior to
crop emergence), in-crop, pre-harvest and post-harvest, allowing a flexible and effective
weed management program:
o When applied prior to seeding, application of it does not delay the seeding step
due to its non-residual activity, therefore increasing flexibility for farming
practices while providing a clean start for the new crop.
o Glyphosate can also be applied in-crop as a postemergence treatment in
conventional crops either as spot treatment or with wiper and wick application to
control weeds taller than crops, which otherwise are impossible to control with
other herbicides.
o The pre-harvest application of glyphosate provides additional benefits to growers
as it functions both as a harvest management and a desiccation treatment:
equalizing the ripening or advancing the ripening process in uneven crops to
achieve an earlier and more uniform harvest, lowering harvested grain seed
moisture content, and increasing combine harvester efficiency. As compared to
alternative crop desiccators such as diquat, glufosinate and carfentrazone,
glyphosate also controls perennial weeds and can be used in a wider range of
crops.
o Post-harvest stubble treatment with glyphosate allows reduced or zero tillage,
which has facilitated the adoption of conservation agriculture, where appropriate,
thus reducing soil erosion, improving soil structure and retaining soil moisture as
well as providing other benefits such as reduced tractor and fuel use.

Proposed Re-evaluation Decision – PRVD2015-01
Page 42

 Value to Non-agricultural Land Management
Glyphosate is also an important weed control tool in non-agricultural land management for these
reasons:
• Due to its flexible use pattern and broad weed control spectrum, it is the most widely
used herbicide in forestry. It can be applied at various stages in the forest regeneration
cycle including site preparation, conifer release and stand thinning stages. Compared to
alternative herbicides such as phenoxy, sulfonylnurea and triclopyr, glyphosate controls
a wider range of weeds. Special application methods such as cut stump or injection
treatment allow for year round application.
• It is also one of the widely used herbicides for pasture renovation, around structures on
farms, amenity and industrial areas, and along rights-of-way.
• It is an effective tool for the control of many invasive weed species and for the control of
toxic plants such as poison ivy.
For some speciality or minor use crops, glyphosate provides specific selective weed control
techniques (weed wipers, shrouded sprayers and stem injection) where in many cases selective
use of glyphosate is the only method of weed control possible or remaining in pasture and
rangeland, vegetables, fruit crops and for the control of invasive weeds among desirable
plants/trees.
Glyphosate has a unique mode of action and is the only molecule that is highly effective at
inhibiting the enzyme EPSP of the shikimate pathway. It plays a role in delaying herbicide
resistance development in weeds when used in rotation or combination with active ingredients
from other herbicide site of action groups. However, the current Canadian agricultural
production system relies heavily on glyphosate, resulting in more and more occurrences of
glyphosate-resistant weeds. Kochia, Canada fleabane, giant ragweed and common ragweed are
examples of such resistant weeds reported in Canada. These glyphosate-resistant weeds affect
the efficacy and broader value of glyphosate. In order to prevent or delay the development of
glyphosate-resistant weeds, it is crucial to maintain diversity in weed management practices.
5.2

Commercial Class Products

A total of 97 Commercial Class end-use products containing glyphosate were registered as of
3 May 2012. All Commercial Class glyphosate uses are supported by the registrant. As risk
concerns identified can be mitigated, alternatives to the uses of glyphosate are not presented in
this document.
5.3

Domestic Class Products

A total of 34 Domestic Class products containing glyphosate were currently registered as
of 3 May 2012. All Domestic Class glyphosate uses are supported by the registrant. As risk
concerns identified can be mitigated, alternatives to the uses of glyphosate are not presented in
this document.

Proposed Re-evaluation Decision – PRVD2015-01
Page 43

 6.0

Pest Control Product Policy Considerations

6.1

Toxic Substances Management Policy Considerations

The Toxic Substances Management Policy (TSMP) is a federal government policy developed
to provide direction on the management of substances of concern that are released into the
environment. The TSMP calls for the virtual elimination of Track 1 substances, those that meet
all four criteria outlined in the policy: in other words, persistent (in air, soil, water and/or
sediment), bio-accumulative, primarily a result of human activity and toxic as defined by the
Canadian Environmental Protection Act.
During the review process, glyphosate was assessed in accordance with the PMRA Regulatory
Directive DIR99-03 3 and evaluated against the Track 1 criteria. The PMRA has reached the
following conclusions:
•
•

Glyphosate does not meet all Track 1 criteria and is not considered a Track 1 substance
(see Table 6.1).
Glyphosate does not form any transformation products that meet the Track 1 criteria.

The use of glyphosate is not expected to result in the entry of TSMP Track 1 substances into the
environment.

3

DIR99-03, The Pest Management Regulatory Agency’s Strategy for Implementing the Toxic Substances
Management Policy.

Proposed Re-evaluation Decision – PRVD2015-01
Page 44

 Table 6.1

Toxic Substances Management Policy Considerations – Comparisons to
TSMP Track 1 Criteria

TSMP Track 1
Criteria
Toxic or toxic
equivalent as defined
by the Canadian
Environmental
Protection Act1
Predominantly
anthropogenic2

TSMP Track 1 Criterion
Value

Glyphosate
Are Criteria Met?

Yes

Yes

Yes

Yes

Soil
Water
Sediment

Half-life
≥ 182 days
Half-life
≥ 182 days
Half-life
≥ 365 days

Persistence3:

Air

Half-life ≥ 2
days or
evidence of
long range
transport

No for aerobic soils: 15.3-142 days.
Some potential for anaerobic soils: 3-1699 days.
No: 1-5.4 days (water phase in aerobic system).
No: 26-58.1 days (sediment phase in aerobic system).
Glyphosate has a low vapour pressure of 6.0 × 10-7 Pa at
20ºC (4.5 × 10-9 mm Hg) and according to the
classification of Kennedy and Talbert (1977) is expected
to be relatively non-volatile under field conditions.
However, the Henry’s law constant of 0.168 Pa m3/mole
(equivalent to 1.66 × 10-6 atm m3/mole and a calculated
1/H = 3.38 × 104) indicates that glyphosate is slightly
volatile from water surface or moist soil. The EFSA
(2009) reported that glyphosate volatilization from water,
soil and plant surfaces is expected to be low.

Log Kow ≥ 5
Log Kow = 4.1
BCF ≥ 5000
BCF = 248-430
BAF ≥ 5000
NA
Is the chemical a TSMP Track 1 substance (all four
No, does not meet TSMP Track 1 criteria.
criteria must be met)?
1
All pesticides will be considered toxic or toxic equivalent for the purpose of initially assessing a pesticide against
the TSMP criteria. Assessment of the toxicity criterion may be refined if required (in other words, all other TSMP
criteria are met).
2
The policy considers a substance “predominantly anthropogenic” if, based on expert judgement, its concentration
in the environment medium is largely due to human activity, rather than to natural sources or releases.
3
If the pesticide and/or the transformation product(s) meet one persistence criterion identified for one media (soil,
water, sediment or air) than the criterion for persistence is considered to be met.
4
Field data (for example, bioaccumulation factors [BAFs]) are preferred over laboratory data (for example,
bioconcentration factors [BCFs]) which, in turn, are preferred over chemical properties (for example, log Kow).
Bioaccumulation4

Proposed Re-evaluation Decision – PRVD2015-01
Page 45

 6.2

Formulants and Contaminants of Health or Environmental Concern

During the review process, contaminants in the technical product are compared against the list in
the Canada Gazette. 4 The list is used as described in the PMRA Notice of Intent NOI2005-01 5
and is based on existing policies and regulations including: DIR99-03; and DIR2006-02 6, and
taking into consideration the Ozone-depleting Substance Regulations, 1998, of the Canadian
Environmental Protection Act (substances designated under the Montreal Protocol). The PMRA
has reached the following conclusions:
•

•

Based on the manufacturing process used, impurities of human health or environmental
concern as identified in the Canada Gazette, Part II, Vol. 142, No. 13, SI/2008-67
(2008-06-25), including TSMP Track 1 substances, are not expected to be present in the
glyphosate products.
Technical grade Glyphosate and its end-use products do not contain any formulants or
contaminants of health or environmental concern identified in the Canada Gazette.

The use of formulants in registered pest control products is assessed on an ongoing basis through
PMRA formulant initiatives and Regulatory Directive DIR2006-02 (PMRA Formulants Policy).

7.0 Organisation for Economic Co-operation and Development Status of
Glyphosate
Canada is part of the Organisation for Economic Co-operation and Development (OECD), which groups
member countries and provides a forum in which governments can work together to share experiences
and seek solutions to common problems.
As part of the re-evaluation of an active ingredient, the PMRA takes into consideration recent
developments and new information on the status of an active ingredient in other jurisdictions, including
OECD member countries. In particular, decisions by an OECD member country to prohibit all uses of an
active ingredient for health or environmental reasons are considered for relevance to the Canadian
situation.
Glyphosate is currently acceptable for use in other OECD countries, including the United States, Australia
and the European Union. As of 17 March 2015, no decision by an OECD member country to prohibit all
uses of glyphosate for health or environmental reasons has been identified.

4

Canada Gazette, Part II, Volume 139, Number 24, SI/2005-114 (2005-11-30) pages 2641–2643: List of
Pest Control Product Formulants and Contaminants of Health or Environmental Concern and in the order
amending this list in the Canada Gazette, Part II, Volume 142, Number 13, SI/2008-67 (2008-06-25) pages
1611-1613. Part 1 Formulants of Health or Environmental Concern, Part 2 Formulants of Health or
Environmental Concern that are Allergens Known to Cause Anaphylactic-Type Reactions and Part 3
Contaminants of Health or Environmental Concern.

5

NOI2005-01, List of Pest Control Product Formulants and Contaminants of Health or Environmental
Concern under the New Pest Control Products Act.

6

DIR2006-02, PMRA Formulants Policy.

Proposed Re-evaluation Decision – PRVD2015-01
Page 46

 8.0

Summary

8.1

Human Health and Safety

The toxicology database submitted for glyphosate is adequate to define the majority of toxic
effects that may result from exposure. Observations of slight systemic toxicity consisting of
decreased body weight and body-weight gain, altered hepatic and renal functions, and diarrhea
were common in the toxicity studies with glyphosate. Cellular changes in the salivary glands
were also observed in the rodent studies. Glyphosate was not genotoxic or neurotoxic. A
marginally increased incidence of ovarian adenomas was observed in mice, but at the limit dose
only. These tumours were considered to be of low degree of concern for human health risk
assessment. Glyphosate produced an altered response of the immune system. No evidence of
increased sensitivity of the young was observed in the reproduction or prenatal developmental
toxicity studies.
However, the finding of fetal cardiovascular malformations in the presence of maternal toxicity
in a rabbit developmental toxicity was considered a serious effect. The risk assessment protects
against the toxic effects noted above by ensuring that the level of human exposure is well below
the lowest dose at which these effects occurred in the animal tests.
8.1.1

Dietary Risk

There were no dietary risk concerns from the acute and chronic dietary risk assessments (food
and drinking water) for the general population and all population subgroups, including infants,
children, teenagers, adults and seniors.
8.1.2

Non-Occupational Risk

Risks to residential applicators for all residential label uses are not of concern. Residential
postapplication risk is not of concern, including from golfing and incidental oral exposure. There
is no risk of concern for bystanders entering treated sites.
8.1.3

Occupational Risk

Risk estimates associated with mixing, loading and applying activities for all commercial label
uses are not of concern.
Postapplication risks for workers were not of concern. An REI of 12 hours is required for all
agricultural postapplication activities.
8.1.4

Aggregate Risk

There were no risks of concern from aggregate exposure to glyphosate from food, drinking water
and residential uses.

Proposed Re-evaluation Decision – PRVD2015-01
Page 47

 8.1.5

Polyethoxylated Tallow Amines

No risks of concern were identified, provided end-use products contain no more than 20% POEA
by weight.
8.2

Environmental Risk

Available studies indicate that in the natural environment, glyphosate is non-persistent to
moderately persistent in soil and water and produces one major transformation product in soil
and water, aminomethyl phosphonic acid (AMPA), which is non-persistent to persistent in the
environment. Carryover of glyphosate and AMPA into the next growing season is not expected
to be significant. Glyphosate and AMPA are expected to be immobile in soil and are unlikely
to leach to groundwater. Glyphosate is very soluble in water and non-volatile and is expected
to partition to sediment in aquatic environments. Glyphosate and AMPA are unlikely to
bioaccumulate.
Certain glyphosate formulations include the surfactant POEA, which is non-persistent to
slightly persistent in the environment and is toxic to aquatic organisms. In general, glyphosate
formulations that contain POEA are more toxic to freshwater and marine/estuarine organisms
than formulations that do not contain POEA. POEA compounds have the potential to
bioaccumulate but given that the components are easily broken down and that it is not persistent
in soil and water, significant bioaccumulation under field conditions is unlikely.
In the terrestrial environment the only area of risk concern identified from the available data was
for terrestrial plants and therefore spray buffer zones are required to reduce exposure to sensitive
terrestrial plants. Glyphosate formulations containing POEA may pose a risk to freshwater
invertebrates, freshwater plants and marine/estuarine invertebrates. Glyphosate formulations that
do not contain POEA may pose a risk to freshwater algae only. Glyphoste technical grade active
ingredient is toxic to estuarine/marine fish. Hazard statements and mitigation measures (spray
buffer zones) are required on product labels to protect aquatic organisms.
Due to its rapid dissipation and low toxicity, the transformation product AMPA is not expected
to pose a risk to terrestrial and aquatic organisms based on proposed application rate of
glyphosate.
8.3

Value

Glyphosate is an important herbicide for Canadian agriculture as well as for weed control in
non-agricultural land management.

Proposed Re-evaluation Decision – PRVD2015-01
Page 48

 9.0

Proposed Re-evaluation Decision

9.1

Proposed Regulatory Actions

After a re-evaluation of glyphosate, Health Canada’s PMRA, under the authority of the Pest
Control Products Act, is proposing continued registration of glyphosate and associated end-use
products for certain uses of glyphosate in Canada, provided that the mitigation measures for the
health and the environment described in this document are implemented.
9.1.1

Proposed Regulatory Action Related to Human Health

9.1.1.1 Proposed Label Amendments
1) Label amendments for the glyphosate technical product labels are proposed and
summarized in Appendix XII.
2) The restricted entry interval of 12 hours is proposed for all agricultural uses
(Appendix XII).
3) There may be potential for exposure to bystanders from drift following pesticide
application to agricultural areas. In the interest of promoting best management practices
and to minimize human exposure from spray drift or from spray residues resulting from
drift, label statement is proposed under Use Precautions (Appendix XII).
9.1.1.2 Residue Definition for Risk Assessment and Enforcement
Glyphosate is registered for use on a wide range of conventional crops (in other words,
glyphosate non-tolerant crops) as well as on transgenic crops (in other words, glyphosate
tolerant crops). Currently registered transgenic crops include crops containing the
5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) gene and/or the glyphosate
oxidoreductase (GOX) gene and crops containing the glyphosate N-acetyl transferase (GAT)
gene (in other words, soybeans, corn and canola). The residue definition (RD) in all conventional
crops and in transgenic EPSPS/GOX crops is comprised of glyphosate and the metabolite
AMPA. The RD in transgenic GAT crops is the sum of glyphosate and the metabolites
N-acetylglyphosate, AMPA and N-acetyl AMPA. The RD in animal commodities is the sum
of glyphosate and the metabolites N-acetylglyphosate and AMPA. These RDs are used for
both enforcement and dietary risk assessment purposes. No modification to the current RDs is
proposed as the result of this re-evaluation. The metabolites included in the RDs are expressed
as stoichiometric equivalents of glyphosate. The RD in drinking water for dietary risk assessment
is defined as the sum of glyphosate and the metabolite AMPA. The acetylated metabolites are
not included in the RD for drinking water because they are not formed in soil. In other words,
N-acetylglyphosate is not applied to plants; it is rather a metabolite produced in GAT crops as a
result of the application of glyphosate.

Proposed Re-evaluation Decision – PRVD2015-01
Page 49

 9.1.1.3 Maximum Residue Limits for Glyphosate in Food
Maximum residue limits (MRLs) have been specified for residues of glyphosate (including all
the metabolites comprised in the RDs) and the trimethylsulfonium (TMS) cation, the major
metabolite of the discontinued glyphosate-TMS salt, in/on registered crops. Information on
Canadian MRLs is presented in Appendix VI.
MRLs for pesticides in/on food are established by Health Canada’s PMRA under the authority
of the Pest Control Products Act. After the revocation of an MRL or where no specific MRL
is specified for a pesticide under the Pest Control Products Act, Subsection B.15.002(1) of the
Food and Drug Regulations applies. This requires that residues do not exceed 0.1 ppm, which is
considered as a general MRL for enforcement purposes. Therefore, residues in/on all other crops
appearing on the registered glyphosate labels are regulated under the general MRL not to exceed
0.1 ppm for glyphosate (including relevant metabolites) and 0.1 ppm for the TMS cation.
In general, when the re-evaluation of a pesticide has been completed, the PMRA intends to
remove Canadian MRLs that are no longer supported. Given that all glyphosate-TMS-containing
products have been discontinued, it is proposed that all MRLs for the TMS cation be revoked.
A complete list of MRLs established in Canada can be found in the PMRA MRL database on the
Pesticides and Pest Management section of the Health Canada website. The database is an online
query application that allows users to search for established MRLs regulated under the Pest
Control Products Act. For supplemental MRL information regarding the international situation
and trade implications, refer to Appendix VI.
9.1.1.4 Proposed Mitigation Measures Related to Products Containing Polyethoxylated
Tallow Amines
The determination of acceptable risk for the POEA health evaluation is applicable to end-use
products that contain no more than 20% POEA by weight. As such, registrants will be required
to ensure that end-use products comply with the maximum of 20% POEA by weight.
9.1.2

Proposed Regulatory Action Related to the Environment

To reduce the effects of glyphosate in the environment, mitigation in the form of precautionary
label statements and spray buffer zones are required. Environmental mitigation statements are
listed in Appendix XII.
9.1.3

Other Label Amendments

Information on cumulative rate per year, maximum number of applications per year and
minimum interval between applications is not currently specified on labels for use on agricultural
cropland and non-cropland, as it is for fruit tree, berry and vine crops. In order for use directions
for glyphosate products to be consistent with the assumptions used in the PMRA health risk
assessment, it is recommended that labels be updated to include this information for all sites,
as described in Appendix II.
Proposed Re-evaluation Decision – PRVD2015-01
Page 50

 9.2

Additional Data Requirements

No additional data are required under section 12 of the Pest Control Products Act.
Note that in addition to data supplied by registrants and published information, certain studies
from non-glyphosate task forces were used in the risk assessments. These are included in the
reference list of this document:
•

Activity specific transfer coefficients from the Agricultural Reentry Task Force (ARTF,
2008) were used in the assessment of postapplication agriculture exposure.

•

The USEPA Residential SOPs (2012) were also used in the risk assessment for
glyphosate. Data from several exposure task forces were used to develop the Residential
SOPs. Specifically ARTF, Agricultural Handlers Exposure Task Force (AHETF), and
Outdoor Residential Exposure Task Force (ORETF) data are included in the scenarios
used from the SOPs.

Furthermore, the PMRA is in the process of revising its approach to buffer zones for all
chemicals. Information (data, research) that would facilitate buffer zone refinement may be
submitted during the consultation period of this Proposed Re-evaluation Decision. Buffer zones
for glyphosate may be revised based on new information as a result of this process.

Proposed Re-evaluation Decision – PRVD2015-01
Page 51

  

Proposed Re?evaluation Decision PRVD2015-01
Page 52

List of Abbreviations

List of Abbreviations
Abs.
AD
ADI
ADME
AFC
a.e.
AHETF
AHS
a.i.
ALT
AMPA
ALP
AR
ARfD
ARTF
AST
ATPD
atm
BAF
BCF
BUN
bw
BWG
[Ca++]
CAF
CAS
CFIA
cm
cm2
CSFII
DA
DBH
DFOP
DFR
DNA
DT50
DT90
EbR50
EC25
EC50
EDE
EEC
EFSA

Absolute
administered dose
acceptable daily intake
absorption, distribution, metabolism and excretion
antibody forming cell
acid equivalent
Agricultural Handlers Exposure Task Force
agricultural health study
active ingredient
alanine aminotransferase
aminomethylphosphonic acid
alkaline phosphatase
applied radioactivity
acute reference dose
Agricultural Re-entry Task Force
Aspartate transaminase
area treated per day
atmosphere
bioaccumulation factor
bioconcentration factor
blood urea nitrogen
body weight
body-weight gain
concentration of calcium
composite assessment factor
Chemical Abstracts Service
Canadian Food Inspection Agency
centimetres
entimetres squared
Continuing Surveys of Food Intakes by Individuals
dermal absorption
diameter at breast height
double first order in parallel
dislodgeable foliar residue
deoxyribonucleic acid
dissipation time 50% (the time required to observe a 50% decline in
concentration)
dissipation time 90% (the time required to observe a 90% decline in
concentration)
effective biomass rate on 50% of the population
effective concentration on 25% of the population
effective concentration on 50% of the population
estimated daily exposure
estimated environmental concentration
European Food Safety Authority

Proposed Re-evaluation Decision – PRVD2015-01
Page 53

 List of Abbreviations

EIIS
EPA
EPSPS
ER50
ERS
et al.
EXAMS
F1
F2
F2b
FC
FE
FIR
FOB
g
GAT
GD
GMO
GOX
GUS
ha
HC
HC5
HED
hr(s)
HPLC
IARC
IgM
IUPAC
IV
[K+]
kg
Kd
KF
Koc
Kow
L
LC50
LD
LD50
LOAEL
LOC
LOEC
LOD
LOQ
LR50
m
m2

Ecological Incident Information System from USEPA
Environmental Protection Agency
5-enolpyruvylshikimate-3-phosphate synthase
effective rate on 50% of the population
exposure re-evaluation section
and others
Exposure Analysis Modeling System
first generation
second generation
pertaining to offspring produced from the second mating of the second generation
food consumption
food efficiency
food ingestion rate
functional observational battery
gram(s)
glyphosate N-acetyl transferase
gestation day
genetically modified organism
glyphosate oxidoreductase
groundwater ubiquity score
hectare
historical control
hazardous concentration to 5% of the species
Health Evaluation Directorate
hour(s)
high performance liquid chromatography
International Agency for Research on Cancer
Immunoglobulin M
International Union of Pure and Applied Chemistry
intravenous(ly)
concentration of potassium ion
kilogram(s)
soil-water partition coefficient
Freundlich adsorption coefficient
organic-carbon partition coefficient
octanol-water partition coefficient
litre(s)
lethal concentration to 50%
lactation day
lethal dose to 50%
lowest observed adverse effect level
level of concern
lowest observed effect concentration
limit of detection
limit of quantitation
lethal rate 50%
metres
metres squared
Proposed Re-evaluation Decision – PRVD2015-01
Page 54

 List of Abbreviations

max
mg
min
MIS
mL
M/L/A
mmHg
MOE
MRL
MS
MTD
n/a
N/A
ND
NOAEL
NOEC
NOEL
NR
NTP
NZW
OC
OECD
OM
ORETF
P
pChE
PDP
PHED
PHI
pKa
PMRA
PND
POEA
PPE
PRZM
ppm
RBC
RD
REI
Rel.
RfD
ROW
RSD
RQ
S9
SD
SFO
SOP

maximum
milligram
minutes
maximal irritation score
millilitre
mixer/loader/applicator
millimetres of mercury
margin of exposure
maximum residue limit
mass spectrometry
maximum tolerated dose
not available
not applicable
not determined
no observed adverse effect level
no observed effect concentration
no observed effect level
not reported
National Toxicology Program
New Zealand White
organic carbon content
Organisation for Economic Co-Operation and Development
organic matter content
Outdoor Residential Exposure Task Force
parental generation
plasma cholinesterase
Pesticide Data Program (United States data)
Pesticide Handlers Exposure Database
preharvest interval
dissociation constant
Pest Management Regulatory Agency
postnatal day
polyethoxylated tallow amine
personal protective equipment
Pesticide Root Zone Model
parts per million
red blood cell
residue definition
restricted entry interval
relative
reference dose
right-of-way
Relative Standard Deviation
risk quotient
supernatant fraction from liver homogenate obtained by centrifuging at 9000 g
Sprague-Dawley
single first order
standard operating procedure
Proposed Re-evaluation Decision – PRVD2015-01
Page 55

 List of Abbreviations

t1/2
trep ½
TC
TLC
TMS
TSMP
TTR
UF
µg
µL
USC
USDA
USEPA
UV
Vss
v/v
WHO
Wk
Wt.

half-life
representative half-life of kinetic models
transfer co-efficient
thin layer shromatography
trimethylsulfonium
Toxic Substances Management Policy
turf transferable residue
uncertainty factor
microgram
microlitres
use site category
United States Department of Agriculture
United States Environmental Protection Agency
ultraviolet
volume of distribution at steady state
volume per volume dilution
World Health Organization
week
weight

Proposed Re-evaluation Decision – PRVD2015-01
Page 56

 Appendix I

Appendix I

Products Containing Glyphosate that are Registered in
Canada Excluding Discontinued Products or Products with a
Submission for Discontinuation as of 3 May 2012, Based Upon
the PMRA’s Electronic Pesticide Regulatory System (e-PRS)
Database1

Registration
Number

Marketing
Type2

Registrant Name

Product Name

Formulation
Type

Guarantee3
(Salt Form –
g a.e./L)

29995

C

Agwest Inc.

Crush’r Plus

Solution

GPI-360

28322

C

Albaugh Inc.

Clearout 41 Plus Herbicide Solution

Solution

GPI-360

30093

C

Alligare, LLC.

Alligare Glyphosate 4+

Solution

GPI-360

29677

C

Chanoix Trading Inc.

Lajj Plus

Solution

GPI-360

Solution

GPI-356

26828

C

Cheminova Glyphosate Soluble Concentrate
Herbicide

27287

C

Glyfos Au Soluble Concentrate Herbicide

Solution

GPI-360

28925

C

Cheminova Glyphosate (TM) II

Solution

GPI-356

Cheminova Canada,
Inc.

29363

C

Glyfos Bio Herbicide

Solution

GPI-360

29364

C

Glyfos Bio 450 Herbicide

Solution

GPI-450

30234

C

Forza Bio Silvicultural Herbicide

Solution

GPI-360

30235

C

Forza Bio 450 Silvicultural Herbicide

Solution

GPI-450

27394

C

Prepass B Herbicide Solution (A Component
Of Prepass Htm)

Solution

GPI-360;

27615

C

Vantage Plus Max Herbicide Solution

Solution

GPI-480

28245

C

Maverick II Herbicide Solution

Solution

GPI-480

28540

C

Eclipse II B Herbicide Solution

Solution

GPI-480

28977

C

Maverick III Herbicide Solution

Solution

GPX-480

29033

C

Eclipse III B Herbicide

Solution

GPX-480

29652

C

Prepass XC B Herbicide

Solution

GPX-480

29994

C

21262

C

29731

C

Dow Agrosciences
Canada Inc.

Vantage XRT Herbicide

Solution

GPX-480

Diamondback Herbicide Shells

Paste

GPI-0.15

Glyking

Solution

GPI-360

C

Clean-Up

Solution

GPI-360

26846

C

Glyphosate Herbicide – Agricultural and
Industrial

Solution

GPI-360

29216

C

Glyphosate Water Soluble Herbicide

Solution

GPI-309(+51)

29266

C

Knockout Extra

Solution

GPI-360

29517

C

Burndown

Solution

GPI-360

29524

C

Clearcrop

Solution

GPI-360

29525

C

Cleanfield

Solution

GPI-360

29733

C

GP Advantage

Solution

GPI-360

28623

C

Sharpshooter Plus Herbicide

Solution

GPI-360

28631

C

Sharpshooter Herbicide

Solution

GPI-356

Wise Up Herbicide Solution

Solution

Ezject, Inc.
Global Ag Brands Inc.

29732

29126
19536

C

Interprovincial
Cooperative Limited

Libertas Now Inc.

Loveland Products
Canada Inc.
Mey Canada
Corporation

C

Rustler Summerfallow Herbicide

Solution

Mocan 943 Water Soluble Herbicide

Solution

Monsanto Canada Inc.
20423

C

Proposed Re-evaluation Decision – PRVD2015-01
Page 57

GPI-356
GPI-108
DXB-182
GPI-120
DIC-86

 Appendix I
Registration
Number

Marketing
Type2

21572

Guarantee3
(Salt Form –
g a.e./L)
GPI-132
DIC-60
GPI-300
GLG-16
GPI-300
GLG-10
GPI-132
DXB-82
GPI-300
GLG-36
GPI-180
GLG-131

Product Name

Formulation
Type

C

Rustler Fallow Liquid Herbicide

Solution

25604

C

Roundup Fast Forward Preharvest Herbicide

Solution

25795

C

Roundup Fastforward Preseed Agricultural

Solution

25898

C

Focus Herbicide

Solution

25918

C

Mon 77759 Water Soluble Herbicide

Solution

26625

C

Mon 78027 Water Soluble Herbicide

Solution

26920

C

Roundup Transorb Max Liquid Herbicide

Solution

GPI-480

Registrant Name

27200

C

Rustler Liquid Herbicide

Solution

GPI-194
DIC-46

29841

C

Mon 76431 Liquid Herbicide

Solution

GPP-540

29868

C

Mon 76429 Liquid Herbicide

Solution

GPP-540

29290

C

Mpower Glyphosate

Solution

GPI-356

25866

C

Nufarm Credit Liquid Herbicide

Solution

GPI-356

27950

C

Credit Plus Liquid Herbicide

Solution

GPI-360

29124

C

Credit 45 Herbicide

Solution

GPI-450

29125

C

Nufarm Credit 360 Liquid Herbicide

Solution

GPI-360

29470

C

Nuglo Herbicide

Solution

GPI-450

29471

C

Nufarm Glyphosate 450 Herbicide

Solution

GPI-450

29479

C

Polaris

Solution

GPI-360

29480

C

Racketeer

Solution

GPI-360

29888

C

Credit Xtreme Herbicide

Solution

GPO-540

30442

C

The Rack Glyphosate

Solution

GPI-360

28802

C

Cycle Herbicide

Solution

GPP-500

29308

C

Touchdown Pro Herbicide

Solution

GPM-360

29341

C

Halex GT Herbicide

Solution

29552

C

Takkle Herbicide

Solution

29644

C

Flexstar Herbicide

Solution

30412

C

Flexstar GT Herbicide

Solution

29022

C

Teragro Inc

Weed-Master Glyphosate 41 Herbicide

Solution

GPS-356

29629

C

Viterra Inc.

Viterra Glyphosate

Solution

GPI-360

24359

C+R

Glyfos Soluble Concentrate Herbicide

Solution

GPI-360

Newagco Inc.

Nufarm Agriculture
Inc.

Rack Petroleum Ltd.

Syngenta Canada Inc.

Cheminova Canada,
Inc.

GPP-250
AME-250
MER-25
GPI-140
DIC-70
GPM-315
FOF-79
GPM-271
FOF-67

26401

C+R

Forza Silvicultural Herbicide

Solution

GPI-360

28924

C+R

Glyfos Soluble Concentrate Herbicide II

Solution

GPI-360

26171

C+R

Vantage Plus Herbicide Solution

Solution

GPI-360

26172

C+R

Vantage Herbicide Solution

Solution

GPI-356

26884

C+R

Vantage Forestry Herbicide Solution

Solution

GPI-356

28840

C+R

Vantage Plus Max II Herbicide Solution

Solution

GPX-480

29588

C+R

GF-772 Herbicide

Solution

GPI-360

29773

C+R

Depose Herbicide Solution

Solution

GPI-356

29774

C+R

Durango Herbicide Solution

Solution

GPX-480

Dow Agrosciences
Canada Inc.

Proposed Re-evaluation Decision – PRVD2015-01
Page 58

 Appendix I

Product Name

Formulation
Type

Guarantee3
(Salt Form –
g a.e./L)

Prepass 480 Herbicide Solution

Solution

GPX-480

C+R

Vantage Max Herbicide Solution

Solution

GPS-480

C+R

Ipco Factor 540 Liquid Herbicide

Solution

GPP-540

Matrix Herbicide Solution

Solution

GPX-480

Vector Herbicide Solution

Solution

GPX-480

Mad Dog Plus

Solution

GPI-360

Glyphogan Plus Liquid Herbicide

Solution

GPI-356

Registration
Number

Marketing
Type2

30423

C+R

30516
27988
29775

C+R

30319

C+R

Registrant Name

Interprovincial
Cooperative Limited
Loveland Products
Canada Inc.
Makhteshim Agan Of
North America Inc.

30076

C+R

29219

C+R

19899

C+R

Vision Silviculture Herbicide

Solution

GPI-356

25344

C+R

Roundup Transorb Liquid Herbicide

Solution

GPI-360

27487

C+R

Roundup Weathermax With Transorb 2
Technology Liquid Herbicide

Solution

GPP-540

28486

C+R

Roundup Ultra 2 Liquid Herbicide

Solution

GPP-540

28487

C+R

R/T 540 Liquid Herbicide

Solution

GPP-540

28608

C+R

Mon 79828 Liquid Herbicide

Solution

GPP-540

Monsanto Canada Inc.

28609

C+R

Mon 79791 Liquid Herbicide

Solution

GPP-540

29498

C+R

Start Up Herbicide

Solution

GPP-540

30104

C+R

Mon 76669

Solution

GPP-540

27736

C+R

Vision Max Silviculture Herbicide

Solution

GPP-540

27764

C+R

Roundup Ultra Liquid Herbicide

Solution

GPP-540

27946

C+R

Renegade HC Liquid Herbicide

Solution

GPP-540

28198

C+R

Roundup Transorb HC Liquid Herbicide

Solution

GPP-540

27192

C+R

Touchdown IQ Liquid Herbicide

Solution

GPM-360

28072

C+R

Syngenta Canada Inc.

Touchdown Total Herbicide

Solution

GPP-500

29201

C+R

Traxion Herbicide

Solution

GPP-500

29009

C+R

Teragro Inc

Weed-Master Glyphosate Forestry Herbicide

Solution

GPI-356

26609

D

Glyfos Herbicide 143 Concentrate

Solution

GPI-143

Glyfos Herbicide 7 Ready-To-Use

Solution

GPI-7

Glyfos Concentrate 356 Herbicide

Solution

GPI-356

Glyphosate 18% Herbicide Solution
Concentrate

Solution

GPI-143

Glyphosate 0.96% Herbicide Ready-To-Use

Solution

GPI-7

Roundup Concentrate Non-Selective Herbicide

Solution

GPI-143

Solution

GPI-356

Solution

GPI-7

Tablet

GPS-60

Solution

GPI-7

Solution

GPI-7

Solution

GPI-7.2

Solution

GPI-14.0

Solution

GPI-14.0

Solution

GPI-7

26610

D

26827

D

27351

D

27352

D

22627

D

22759

D

22807

D

23786

D

24299

D

Cheminova Canada,
Inc.

Dow Agrosciences
Canada Inc.

Monsanto Canada Inc.
26263

D

27460

D

27506

D

27507

D

28974

D

Roundup Super Concentrate Grass & Weed
Control
Roundup Ready To Use Non-Selective
Herbicide With Fastact Foam
Roundup Quik Stik Non-Selective Herbicide
Tablets
Roundup Ready-To-Use Grass & Weed
Control With Fastact Foam
Roundup Ready-To-Use With Fastact Foam
Pull'n Spray Non-Selective Herbicide
Roundup Ready-To-Use Non-Selective
Herbicide
Roundup Ready-To-Use Pull’n Spray NonSelective Herbicide
Roundup Ready-To-Use Pull'n Spray Poison
Ivy & Brush Control Non-Selective Herbicide
Roundup Pump’N Go

Proposed Re-evaluation Decision – PRVD2015-01
Page 59

 Appendix I
Registration
Number

Marketing
Type2

29003

D

29034

D

27013

D

27014

D

27015

D

29580

D

29307

D

29309

D

29310

D

28464

D

28467

D

28469

D

28470

D

28471

D

28472

D

28574

D

28575

D

28576

D

28577

D

25600

M

27497

M

26449

M

27074

M

Registrant Name

Formulation
Type

Guarantee3
(Salt Form –
g a.e./L)

Solution

GPI-14

Solution

GPI-14

Later’s Grass & Weed Killer Ready To Use

Solution

GPI-7

Later’s Grass & Weed Killer Concentrate

Solution

GPI-143

Solution

GPI-356

Solution

GPI-7

Touchdown Ready-To-Use Herbicide

Solution

GPM-8.4

Touchdown Super Concentrate Herbicide

Solution

GPM-360

Solution

GPM-8.3
DIQ-0.28

Solution

GPI-143

Solution

GPI-143

Solution

GPI-7

Solution

GPI-7

Solution

GPI-356

Solution

GPI-356

Solution

GPI-7.0

Solution

GPI-7.0

Solution

GPI-14

Solution

GPI-14

Glyphosate Concentrate Herbicide

Solution

GPI-46.3

Glyfos 356 MUC

Solution

GPI-356

Solution

GPI-46

Solution

GPI-356

Solution

GPI-360

Product Name
Roundup Ready-To-Use Poison Ivy & Brush
Control Non-Selective Herbicide
Roundup Ready-To-Use Poison Ivy & Brush
Control With Quick Connect Sprayer

Sure-Gro IP Inc.

Syngenta Canada Inc.

Teragro Inc

Cheminova Canada,
Inc.

Dow Agrosciences
Canada Inc.

Later's Grass & Weed Killer Super
Concentrate
Later's Grass & Weed Killer Ready To Use
EZ Spray

Touchdown Diquat Quick-Kill Ready-To-Use
Herbicide
Totalex Concentrate Brush, Grass & Weed
Killer Home Gardener
Totalex Concentrate Brush, Grass & Weed
Killer Virterra
Totalex Ready-To-Use Brush, Grass & Weed
Killer Virterra
Totalex Ready-To-Use Brush, Grass & Weed
Killer Home Gardener
Totalex Super Concentrate Brush, Grass &
Weed Killer Home Gardener
Totalex Super Concentrate Brush, Grass &
Weed Killer Virterra
Totalex Rtu Brush, Grass & Weed Killer With
1 Touch Power Sprayer Home
Totalex Rtu Brush, Grass & Weed Killer With
1 Touch Power Sprayer
Totalex Extra Strength Rtu Brush, Grass &
Weed Killer With 1 Touch Power Sprayer
Home Gardener
Totalex Extra Strength Rtu Brush, Grass &
Weed Killer With 1 Touch Power Sprayer
Virterra

Glyphosate 62% Solution Manufacturing
Concentrate
Vantage Herbicide Solution Manufacturing
Concentrate
Vantage Plus Herbicide Solution
Manufacturing Concentrate

27075

M

28783

M

Gf-1667 Herbicide Manufacturing Concentrate

Solution

GPX-49

28963

M

Glyphosate 85% Manufacturing Concentrate

Solution

GPS-85

29267

M

Knockout 62

Solution

GPI-46.0

Solution

GPI-46.0

Solution

GPI-46

Solution

GPS-85

Solution

GPP-47.3

Solution

GPP-540

Solution

GPP-540

Solution

GPP-540

21061

M

26919

M

27183

M

27485

M

28603

M

28604

M

28605

M

Libertas Now Inc.

Monsanto Canada Inc.

Mon 0139 Solution Herbicide Manufacturing
Concentrate
Mon 77945 Herbicide Manufacturing
Concentrate Solution
Mon 77973 Herbicide Manufacturing
Concentrate
Mon 78623 Herbicide Manufacturing
Concentrate
Mon 79380 Herbicide Manufacturing
Concentrate
Mon 79582 Herbicide Manufacturing
Concentrate
Mon 79544 Herbicide Manufacturing

Proposed Re-evaluation Decision – PRVD2015-01
Page 60

 Appendix I
Registration
Number

Marketing
Type2

Registrant Name

Product Name

Formulation
Type

Guarantee3
(Salt Form –
g a.e./L)

Solution

GPI-356

Solution

GPI-46

Concentrate
28625

M

29123

M

Nufarm Agriculture
Inc.

Mon 78087 Herbicide Manufacturing
Concentrate
Nufarm Glyphosate IPA Manufacturing
Concentrate

27871

M

Syngenta Canada Inc.

Glyphosate 600 SL Manufacturing Concentrate

Solution

GPS-600

Solution

GPI-46

29719

M

Teragro Inc

Teragro Glyphosate Manufacturing
Concentrate

29645

T

Agromarketing Co.
Inc.

Nasa Glyphosate Technical

Solid

GPS-96.37

28321

T

Albaugh Inc.

Clearout Glyphosate Technical

Solid

GPS-96.7

24337

T

Glyphosate Technical

Solid

GPS-85.8

29143

T

Glyfos Soluble Concentrate Herbicide 2

Solid

GPS-97.9

29326

T

Cheminova Glyphosate Technical II

Solid

GPS-95.7

29530

T

Cheminova Glyphosate Technical III

Solid

GPS-98.2

26450

T

Glyphosate Technical Herbicide

Solid

GPS-96.3

28967

T

Dow Agrosciences
Canada Inc.

Technical Glyphosate Herbicide

Solid

GPS-96.2

29265

T

Libertas Now Inc.

Knockout Tech

Solid

GPS-98.1

29799

T

Mey Corp Glyphosate Technical

Solid

GPS-98.5

Mgt Glyphosate Technical

Solid

GPS-96.4

Cheminova Canada,
Inc.

Mey Corporation
30099

T

19535

T

Monsanto Canada Inc.

Glyphosate Technical Grade

Solid

GPS-96.3

29381

T

Newagco Inc.

Newagco Glyphosate Technical

Solid

GPS-96.0

Nufarm Glyphosate Technical Acid

Solid

GPS-96.5

Sharda Glyphosate Technical Herbicide

Solid

GPS-96.2

Glyphosate Acid Wet Paste Herbicide

Paste

GPS-88.8

Technical Touchdown Herbicide

Solid

GPS-97.1

Touchdown Technical Herbicide

Solid

GPS-99

Glyphosate Technical Herbicide

Solid

GPS-97.5

28857

T

29980

T

24344

T

28983

T

29540

T

28882

T

Nufarm Agriculture
Inc.
Sharda Worldwide
Exports Pvt.
Ltd./Sharda
International Fze
Syngenta Canada Inc.

Teragro Inc

1

GPS = glyphosate acid, GPI = glyphosate isopropylamine or ethnolamine salt, GPM = glyphosate mono-ammonium or diammonium salt, GPP =
glyphosate potassium salt, GPX = glyphosate dimethylsulfonium salt, and GPO = GPI + GPP. Note that GPT (gltphosate trimethylsulfonium salt)
has been voluntarily discontinued by the registrant Syngenta Canada Inc.
2
C = Commercial Class, C+R = Commercial and Restricted Class, D = Domestic Class, M = Manufacturing Concentrate, T = Technical grade
active ingredient.
3
AME = s-metolachlor, DIC = dicamba, DIQ = diquat, DXB = 2,4-D (isomer specific), FOF = fomesafen, GLG = glufosinate ammonium and
MER = mesotrione.

Proposed Re-evaluation Decision – PRVD2015-01
Page 61

 Appendix I

 

 

Proposed Re?evaluation Decision PRVD2015-01
Page 62

Appendix IIa

Appendix IIa Registered Commercial Class Uses of Glyphosate in Canada as
of 3 May 2012. Uses From Discontinued Products or Products
With a Submission for Discontinuation are Excluded1
2

3

USCs

Sites

Weeds and/or
Harvest
Management

Application Methods and
Equipment4

Maximum Application
Rate (kg a.e./ha)

Minimum
Interval
Between
Applications
(Days)5

Single

Cumulative
Per Year5

Maximum
Number of
Applications
Per Year5

4.320

9.542

4

[7]

0.902

0.902

1

Not
applicable

4.320

9.542

6

[7]

Boom or boomless

13
14

13
14

7
13
14

Wheat
Barley
Oats

Rye

Soybeans

Weed control:
Annual and
perennial weeds
Harvest
management

Aerial – Prairie provinces
only (including Peace River
region of British Columbia) –
Restricted use
Knapsack or high-volume
equipment (hose and handguns,
hand sprayer or other suitable
nozzle arrangement)
Field sprayer

Annual weeds
and foxtail
barley

Weed control:
Annual and
perennial weeds
Harvest
management

Aerial – Prairie provinces
only (including Peace River
region of British Columbia) –
Restricted use
Boom or boomless
Aerial – Prairie provinces
only (including Peace River
region of British Columbia) –
Restricted use
Knapsack or high-volume
equipment (hose and handguns,
hand sprayer or other suitable
nozzle arrangement)
Boom or boomless
Roller applicators
Wick or other wiper applicators

[7]
Soybeans

7
13
14

(Glyphosate
tolerant
or Roundup
Ready
soybean
varieties
or Roundup
Ready 2 Yield
soybean
varieties)

Weed control:
Annual and
perennial weeds
Harvest
management

Boom or boomless
Aerial – Prairie provinces
only (including Peace River
region of British Columbia) –
Restricted use

4.320

12.062

Proposed Re-evaluation Decision – PRVD2015-01
Page 63

5

For in crop
treatment,
14 for
sequential
application
and the
second
application
must be no
later than
flowering
stage of
soybean.

 Appendix IIa

USCs2

Sites3

Weeds and/or
Harvest
Management

Application Methods and
Equipment4

Maximum Application
Rate (kg a.e./ha)

Minimum
Interval
Between
Applications
(Days)5

Single

Cumulative
Per Year5

Maximum
Number of
Applications
Per Year5

4.320

8.640

3

[7]

4.320

10.445

4

[7]

4.320

10.438

4

[7]

4.320

9.542

3

[7]

4.320

10.890

5

[7]

0.902

1.804

2
(sequential
application)

At least 5
days

4.320

9.542

3

[7]

4.320

9.542

6

[7]

Boom or boomless

7
13
14

Corn

Annual and
perennial weeds

Aerial – Prairie provinces
only (including Peace River
region of British Columbia) –
Restricted use
Knapsack or high-volume
equipment (hose and handguns,
hand sprayer or other suitable
nozzle arrangement)
Boom or boomless

7
13
14

Corn
(glyphosate
tolerant)

Annual and
perennial weeds

Aerial – Prairie provinces
only (including Peace River
region of British Columbia) –
Restricted use
Boom or boomless

14

Corn – Sweet
(Roundup
Ready 2
Technology)

Annual and
perennial weeds

Aerial – Prairie provinces
only (including Peace River
region of British Columbia) –
Restricted use
Boom or boomless

7
13
14

Canola

7
13
14

Canola
(glyphosate
tolerant)

7

Canola –
Roundup
Ready Hybrid
canola seed
production

13
14

Peas

Weed Control:
Annual and
perennial weeds
Harvest
management
Weed Control:
Annual and
perennial weeds
Harvest
management
When
pollination is
complete or
near completion
Weed Control:
Annual and
perennial weeds
Harvest
management

14

Dry beans

Weed Control:
Annual and
perennial weeds
Harvest
management

Aerial – Prairie provinces
only (including Peace River
region of British Columbia) –
Restricted use
Boom or boomless
Aerial – Prairie provinces
only (including Peace River
region of British Columbia) –
Restricted use

Boom sprayer

Boom or boomless
Aerial – Prairie provinces
only (including Peace River
region of British Columbia) –
Restricted use
Boom or boomless
Aerial – Prairie provinces
only (including Peace River
region of British Columbia) –
Restricted use
Knapsack or high-volume
equipment (hose and handguns,
hand sprayer or other suitable
nozzle arrangement)
Roller applicators
Wick or other wiper applicators

Proposed Re-evaluation Decision – PRVD2015-01
Page 64

 Appendix IIa

USCs2

7
13
14

14

Sites3

Flax
(including low
linoleic acid
varieties)

Lentils

Weeds and/or
Harvest
Management

Weed control:
Annual and
perennial weeds
Harvest
management

Weed control:
Annual and
perennial weeds
Harvest
management

Chickpeas
13
14

Lupin (dried)
Fava bean
(dried)

7
13
14

Mustard
(yellow/white,
brown,
oriental)

13

Pearl millet
(pearl millet
grain is to be
harvested for
use as animal
feed only. Do
not graze
treated pearl
millet forage
or cut for
hay.)

14

7
13
14

Sorghum
(grain) (not
for use as a
forage crop)

Sugar beets

Weed control:
Annual and
perennial weeds
Harvest
management
Weed control:
Annual and
perennial weeds
Harvest
management

Weed control:
Annual and
perennial weeds
Harvest
management

Weed control:
Annual and
perennial weeds
Harvest
management

Annual and
perennial weeds

Application Methods and
Equipment4

Maximum Application
Rate (kg a.e./ha)

Minimum
Interval
Between
Applications
(Days)5

Single

Cumulative
Per Year5

Maximum
Number of
Applications
Per Year5

4.320

9.542

3

[7]

4.320

9.542

3

[7]

4.320

9.542

3

[7]

4.320

9.542

3

[7]

4.320

9.542

3

[7]

4.320

9.542

3

[7]

4.320

12.600

3

[7]

0.902

3.607

4

10

Boom or boomless
Aerial – Prairie provinces
only (including Peace River
region of British Columbia) –
Restricted use

Boom or boomless
Aerial – Prairie provinces
only (including Peace River
region of British Columbia) –
Restricted use
Boom or boomless
Aerial – Prairie provinces
only (including Peace River
region of British Columbia) –
Restricted use
Boom or boomless
Aerial – Prairie provinces
only (including Peace River
region of British Columbia) –
Restricted use

Boom or boomless
Aerial – Prairie provinces
only (including Peace River
region of British Columbia) –
Restricted use

Boom or boomless
Aerial – Prairie provinces
only (including Peace River
region of British Columbia) –
Restricted use
Boom or boomless
Aerial – Prairie provinces
only (including Peace River
region of British Columbia) –
Restricted use
Knapsack sprayers, hand held
and high-volume equipment
handguns or other suitable
nozzle arrangement
Boom or boomless

7
13
14

Sugar beets
(Roundup
Ready only)

Emerged annual
and perennial
weeds

Aerial – Prairie provinces
only (including Peace River
region of British Columbia) –
Restricted use

Proposed Re-evaluation Decision – PRVD2015-01
Page 65

 Appendix IIa

USCs2

Sites3

14

Asparagus

14

Ginseng
(North
American) –
new garden
(BC only)
Ginseng
(North
American) –
Existing/estab
lished gardens

13

Forage
grasses and
legume
including seed
production

Weeds and/or
Harvest
Management
Annual and
perennial weeds

Volunteer grain

Weed control:
Annual and
perennial weeds
Harvest
management
Annual and
perennial
vegetation

13

14

Pasture

Strawberry

Application Methods and
Equipment4

Boom or boomless

Maximum Application
Rate (kg a.e./ha)

Minimum
Interval
Between
Applications
(Days)5

Single

Cumulative
Per Year5

Maximum
Number of
Applications
Per Year5

4.320

12.600

3

[7]

0.902

0.902

1

Not
applicable

0.902

1.804

2

[7]

4.320

10.440

4

[7]

4.320

8.640

2

[7]

4.320

12.600

4

[7]

4.320

12.600

3

[7]

4.320

12.600

3

[7]

4.320

12.600

2

[7]

4.320

12.600

3

[7]

Boom sprayer, shielded
sprayer, hand-held guns

Boom or boomless
Knapsack or high-volume
equipment (hose and handguns,
hand sprayer or other suitable
nozzle arrangement)
Boom or boomless
Mist blower

Most
herbaceous
weeds, woody
brush and trees

Annual and
perennial weeds

Hand-held high volume
equipment
Ground Restricted use
Aerial Restricted use
Boom or boomless
Knapsack or high-volume
equipment (hose and handguns,
hand sprayer or other suitable
nozzle arrangement)
Wiper
Boom or boomless

14

14

14

13
(apples
only)

Blueberry
(highbush)

Annual and
perennial weeds

Blueberry
(lowbush)

Annual and
perennial weeds
Woody brush

Cranberry

Annual and
perennial weeds

Apples
Apricot
Cherry –
(Sweet/Sour)
Peaches

Annual and
perennial weeds

Shielded sprayer, hand held and
high-volume orchards guns
Knapsack or high-volume
equipment (hose and handguns,
hand sprayer or other suitable
nozzle arrangement)
Boom or boomless
Shielded sprayer, hand held and
high-volume orchards guns
Knapsack or high-volume
equipment (hose and handguns,
hand sprayer or other suitable
nozzle arrangement)

Boom or boomless
Wipers and wicks

Boom sprayer, shielded
sprayer, hand held and highvolume orchards guns
Rollers

Proposed Re-evaluation Decision – PRVD2015-01
Page 66

 Appendix IIa

USCs2

14

14

Sites3

Weeds and/or
Harvest
Management

Pears
Plums

Grapes

Application Methods and
Equipment4

Maximum Application
Rate (kg a.e./ha)

Minimum
Interval
Between
Applications
(Days)5

Single

Cumulative
Per Year5

Maximum
Number of
Applications
Per Year5

4.320

12.600

3

[7]

4.320

12.600

[3]

[7]

4.320

12.600

2
Apply as a
directed spray
or as a wiper
solution

[7]

4.320

8.640

4

[7]

4.320

4.320

3

42

4.320

4.320

1

Not
applicable

4.320

4.320

1

Not
applicable

[2]

[7]

Wick or other wiper applicators

Annual and
perennial weeds

Boom sprayer, shielded
sprayer, hand held and highvolume orchards guns
Rollers
Wick or other wiper applicators
Boom or boomless

14

Filberts or
Hazelnut

14

Walnut,
Chestnut,
Japanese
heartnut

Annual weeds

Annual and
perennial weeds

Shielded sprayer, hand held and
high-volume orchards guns
Boom sprayer, shielded
sprayer, hand held and highvolume orchards guns
Wipers

Shelterbelts
Nursery stock

4
27

Woody
ornamentals
Including
forest tree
nursery and
Christmas tree
plantations
– Deciduous

4
27

Short rotation
intensive
culture
(SRIC) poplar

7
13
14

All other
crops – Preseeding

Boom or boomless
Annual and
perennial weeds

Rollers
Wick or other wiper applicators

Boom or boomless
Annual and
perennial weeds

Shielded sprayers for postdirected spray solution

Boom or boomless
Annual and
perennial weeds

Aerial – Prairie provinces
only (including Peace River
region of British Columbia –
Restricted use
Boom or boomless

7
13
14

Summer
fallow

Annual and
perennial weeds

Aerial – Prairie provinces
only (including Peace River
region of British Columbia) –
Restricted use
Boom or Boomless

4

Forest and
Woodlands

Herbaceous
weeds, woody
brush and trees,
Ericaceous
species (for
example,
Kalmia spp.sheep laurel,
lamb kill)

9.000

Mist blower
Aerial – Restricted use
Hand held and high-volume
equipment
Roller application
Wick or other wiper applicators

4.320

This is
derived from
the label of
PCP# 29308
(glyphosate at
360 g/L) in
which the
annual
maximum
rate is 25

Proposed Re-evaluation Decision – PRVD2015-01
Page 67

 Appendix IIa

USCs2

Sites3

Weeds and/or
Harvest
Management

Application Methods and
Equipment4

Maximum Application
Rate (kg a.e./ha)
Single

Cumulative
Per Year5

Maximum
Number of
Applications
Per Year5

Minimum
Interval
Between
Applications
(Days)5

L/ha.
Injection application
The
calculated
cumulative
rate per year
is 8.640 kg
a.e./ha.

Diamondback Herbicide
injection system (EZJECT) and
equipment
Cut stump application
Boom or boomless
Hand held and high-volume
application
Aerial application:
Restricted use
Mist blower

16

Non-crop land
and industrial
uses

Annual and
perennial weeds
Woody brush
and trees

Rollers
4.320

12.960

[3]

[7]

4.320

9.000

2.

[7]

Wick or other wiper applicators
Injection applications
Diamondback Herbicide
injection system (EZJECT)and
equipment
Low pressure equipment (for
example, squirt bottle or similar
device)
Boom or boomless

30

1.
2.
3.

4.
5.

Turf grass
(Prior to
establishment
or renovation)

Annual and
perennial weeds

Mist blower

Hand-held high-volume
application
All uses are supported by the registrants. Information in [ ] is provided by the registrants.
USCs 1 to 14 belong to the use sector AGRICULTURE AND FORESTRY, USCs 15-23 belong to the use sector INDUSTRY and USCs
24-33 belong to the use sector SOCIETY.
Sites are either as stated on the product label or as interpreted by the PMRA so as to achieve consistency in naming. For agricultural
cropland use, the labels state that all crops can be treated with glyphosate prior to planting. This “prior to planting use on all crops” is
captured in two parts. (1) It is captured in the Site column corresponding to the crop which appears on the labels for other use claim(s). For
example, wheat appears on the label for in-crop spot treatment as well as pre-harvest application; the “prior to planting use” is added under
the Wheat site; (2) It is captured in the “All other crops” section of the site column corresponding to the crop which does not appear on the
label (for example, vegetables). Post-harvest stubble use is dealt with similarly. Thus, all claimed uses for a specific site are presented
together.
The Equipment column covers application equipment appearing on all product labels listing all possible application equipment for the
specific site. All aerial applications are restricted uses and in bold text.
Cumulative rate per year, maximum number of applications per year and minimum interval between applications: This information is
currently specified for use on fruit tree, berry and vine crops but is not clearly specified for other uses such as agricultural cropland and noncropland. For agricultural cropland use, crops can, in theory, be treated with glyphosate at each of four windows: pre-planting, in-crop spot,
pre-harvest and/or post-harvest. Typically, only one application at most is made at each application window. However, the product labels
also state that a repeat treatment is required if heavy rainfall occurs immediately after application. In a growing season, it is possible to do
sequential applications at some or all application windows, in other words: prior to planting + in-crop spot + pre-harvest + post-harvest
stubble. For forestry and non-cropland use, the product labels state that repeat applications may be necessary to control late germinating
weeds, regeneration from underground parts or seeds, and new growth or second flush of weeds germinating from the canopy closure.
In addition, for wiper applications, the product labels state that best results may be obtained if two applications are made in opposite
directions. The cumulative product rate per year is expressed to reflect the possible repeat application required if heavy rainfall occurs
immediately after application. The cumulative a.i. rate per year, maximum number of applications per year and minimum interval between
applications for a specific site are expressed to reflect all possible applications across the growing season, representing the worst case
scenario.

Proposed Re-evaluation Decision – PRVD2015-01
Page 68

 Appendix IIb

Appendix IIb Registered Domestic Class Uses of Glyphosate in Canada as of
23 October 2012. Uses from Discontinued Products or
Products with a Submission for Discontinuation are Excluded.1
2

USCs

16

27

14
27

30

16

3

Sites

Weeds

Hard to mow areas,
around buildings,
foundations and
fence posts, lawn
trimming/ edging,
patio, vacant lots,
storage and
recreational areas,
driveways and along
fence lines

Most annual and
perennial grasses
and weeds such as
quackgrass,
chickweed,
ragweed, knotweed,
poison ivy, Canada
thistle, milkweed
and bindweed

Around trees/shrub/
ornamentals

Most annual and
perennial grasses
and weeds such as
quackgrass,
chickweed,
ragweed, knotweed,
poison ivy, Canada
thistle, milkweed
and bindweed

Garden renovation

Lawn renovation

Brush control (for
domestic use)

Most annual and
perennial grasses
and weeds such as
quackgrass,
chickweed,
ragweed, knotweed,
poison ivy, Canada
thistle, milkweed
and bindweed

Application
Equipment

Maximum Application
Rate (g a.e./m2)
Single

Cumulative
Per Year

0.700

1.400

0.386

0.771

0.700

1.400

Maximum
Number of
Applications
Per Year

Minimum
Interval
Between
Applications
(Days)4

Ground
Do not use
hose-end
sprayers
For Ready to
Use products
– Pull’N
Spray or
1 Touch
Power
Sprayer or
with on/off
nozzle or
with child
resistant
closure lock
or EZ
SPRAYTM or
Pump’N Go

Most brush such as
poplar, alder, maple
and raspberry

[2]
0.386

0.771

0.700

1.400

0.386

0.771

0.700

1.400

0.386

0.771

0.700

1.400

0.386

0.771

0.355

0.710

Heavy rainfall
immediately
after application
may wash the
chemical off the
foliage and
repeat treatment
may be
required.

[7]

Use a repeat
application on
any seedlings
that regrow
from seeds or as
new seedlings
and vegetation
emerge.

In flower beds and
vegetable gardens
14
27

30

1.
2.
3.
4.

In large areas for
garden plot
preparation
In large areas for
lawn replacement

Poison ivy and
brush
Most types of weeds
and grasses

Ready to Use
– Pull’N
Spray

All uses are supported by the registrants and the Glyphosate Task Force.
USCs 1 to 14 belong to the use sector AGRICULTURE AND FORESTRY, USCs 15-23 belong to the use sector INDUSTRY and USCs
24-33 belong to the use sector SOCIETY.
Sites are either as stated on the product label or as interpreted by the PMRA so as to achieve consistency in naming.
Information in [ ] is provided by the registrants.

Proposed Re-evaluation Decision – PRVD2015-01
Page 69

 Appendix Ilb

 

 

Proposed Re?evaluation Decision PRVD2015-01
Page 70

Appendix III

Appendix III

Toxicity Profile and Endpoints for Health Risk
Assessment

Table III.1A

Summary of Toxicology Studies for Glyphosate Acid

Note: Effects noted below are known or assumed to occur in both sexes unless otherwise noted;
in such cases, sex-specific effects are separated by semi-colons. Effects on organ weights are
known or assumed to reflect changes in absolute weight and relative (to body weight) weight
unless otherwise noted.
Study Type/
Animal/ PMRA #

Study Results
Toxicokinetic Studies

Single Dose
(Gavage or IV)
F344 Rat
PMRA#: 2391579

Single Dose (IP)
Sprague-Dawley
Rat
PMRA#: 2391580
Single Dose
(Gavage)
Wistar Rat

Absorption: Peak blood radioactivity levels were reached within 1st and 2nd hours of oral
administration for the low and high-dose groups, respectively. The peak blood radioactivity
level was about 0.20% of the administered dose (AD) for the low oral dose and about 0.70%
of the AD for the high oral dose. The 10-fold increase in the oral dose resulted in a 35-fold
increase in the peak blood concentrations. The blood radioactivity versus time plot fit a twocompartment model with a rapid distribution phase of 30 minutes and slower elimination phase
of 13 hours. Blood radioactivity levels declined rapidly following an intravenous dose of
5.6 mg/kg such that within 6 hours of dosing, over 90% of radioactivity was recovered in the
urine. Comparison of the pattern of elimination following i.v. and oral administration of
14
C glyphosate suggested that the compound was incompletely absorbed.
Distribution: Most of the radioactivity levels in the tissues were recovered in the
gastrointestinal (GI) tract (mostly in the small intestine) up to the 12-hour time point following
single oral administration of the low and high doses. Radioactivity was also detected in the
liver, kidneys, skin and blood, but in comparably small amounts to the small and large
intestines (0.1-0.7% of AD in these tissues and at different time-points). The tissue radioactive
residues decreased from 12% of total radioactivity to less than 1% within 24 hours.
Excretion: Following oral administration of 14C-glyphosate, elimination was similar in the low
and high-dose groups although a higher percentage (58-74%) of radioactivity excreted through
the feces and a lower portion (~ 35%) excreted through the urine. The fecal excretion peaked
towards the end of the measurement (72-hour time point) for both dose groups. The urinary
excretion of the radioactivity plateaued at 12 hours in the low-dose group and at 72 hours in
the high-dose groups. Following the intravenous administration of a low dose (5.6 mg/kg) of
14
C-glyphosate, the elimination was rapid (90% excreted within 6 hours) and occurred
primarily through the urine.
Metabolism: The major radioactive excreted component was unchanged glyphosate.
Excretion: feces (6-14%), urine (74-78%) after 5 days, negligible excretion via air. Tissue
retention at 120 hrs was 1%.

Absorption: Rapidly absorbed
Metabolism: The major radioactive excreted component was unchanged glyphosate. 6.9
to 8.6% of AD in feces extracts corresponded to Aminomethylphosphonic acid (AMPA)
Excretion: in urine (14% in ♂, 35-40% in ♀) and feces (81% in ♂) after 48hrs, negligible
excretion via air.

PMRA#: 1184961

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Page 71

 Appendix III

Study Type/
Animal/ PMRA #
Single Dose
(Gavage)
Wistar Rat
PMRA#: 1212026

Single Dose
(Gavage)
Wistar Rat
PMRA#: 1212027

Single Dose
(Gavage)
Wistar Rat

Study Results
Absorption: Incomplete (based on increased rapid fecal excretion)
Distribution: Autoradiograms showed greater intensity of the radioactivity in bones and
kidneys (reducing to negligible amounts by 48 hrs in kidneys.)
Excretion: In urine (17.9% in ♂, 12.8% in ♀) and feces (59.3% in ♂, 80.3% in ♀) after 24
hours. In urine (34% in ♂, 12.5% in ♀) and feces (60.5% in ♂, 91.2% in ♀) after 48 hours.
Radioactivity recovered in the expired air was negligible.
Absorption: Incomplete (based on increased rapid fecal excretion)
Distribution: Less than 0.19/0.17% in ♂/♀ of AD present in the GI tract after 72 hrs. Tissue
concentrations accounted for 0.5% of AD. Highest concentrations were in bone, liver, kidneys
and lungs.
Excretion: About 90% excreted within 24 hrs of dosing. In urine (13% in ♂, 11% in ♀) and
feces (88.5% in ♂, 89% in ♀) after 72 hours
Absorption: Incomplete (based on increased rapid fecal excretion)
Distribution: Less than 0.12% of AD present in the GI tract after 72 hrs. Tissue concentrations
accounted for 0.5% of AD. Highest concentrations were in bone, liver, and kidneys.

Single Dose
(Gavage)

Excretion: About 90% excreted within 24hrs of dosing. In urine (11% in ♂, 11% in ♀) and
feces (87% in ♂, 91% in ♀) after 72 hours
Absorption: Based on excretion and tissue distribution, the extent of absorption of an oral dose
of glyphosate did not exceed 21%.

Wistar Rat

Distribution: Tissue concentrations were not examined in this study.

PMRA#: 1212029

Metabolism: Poor metabolism since the parent (unchanged) compound excreted in the urine.

PMRA#: 1212028

Excretion: Unchanged glyphosate acid with < 1% AMPA in urine. Unchanged glyphosate acid
in feces

Single Dose
(Gavage)
Wistar Rat

1000 mg/kg bw bile duct cannula dose: in urine (20.8% in ♂, 16.3% in ♀) and feces (39.1% in
♂, 30.5% in ♀), bile (0.06% in ♂ and ♀) after 48 hrs.
1000 mg/kg bw: in urine (16.0% in ♂, 16.7% in ♀) and feces (79.3% in ♂, 63.9% in ♀)
10 mg/kg bw after 14 unlabelled doses: in urine (10.5% in ♂, 10.5% in ♀) and feces (52.9% in
♂, 72.1% in ♀)
10 mg/kg bw: in urine (12.7% in ♂, 10.5% in ♀) and feces (74.8% in ♂, 55.2% in ♀)
Absorption: higher in fasted vs. non-fasted animals based on urinary and fecal radioactivity
levels
Distribution: The residues in carcass accounted for 2% of the dose in fasted and 0.5% in nonfasted animals. The residues in GI tract were 0.23% in fasted and 0.13% in non-fasted animals.

PMRA#: 1212031
Single Dose (IV)
Wistar Rat
PMRA#: 1212032
Single Dose
(Gavage)

Excretion: in urine (fasted: 51%, non-fasted: 15%) and feces (fasted: 47%, non-fasted: 85%)
Distribution: Around 3% of radioactivity was recovered in all tissues that included in
decreased order of concentration: bone, spleen, kidneys, lungs, liver, GI tract and salivary
glands.
Excretion: in urine (88.3% in ♂, 74.6% in ♀) and feces (5.1% in ♂, 14.2% in ♀) after 72
hours
Absorption: Incomplete (based on increased rapid fecal excretion)
Distribution: Tissue concentration of radioactivity was low (accounted for less than 0.6% of

Proposed Re-evaluation Decision – PRVD2015-01
Page 72

 Appendix III

Study Type/
Animal/ PMRA #
Wistar Rat
PMRA#: 1212033

Single Dose
(Gavage or IV)
Non-guideline
Wistar Rat

Study Results
the AD). Highest concentration in bone > kidneys > liver > lungs > spleen > salivary glands >
brain.
Excretion: Over 87% excreted within 24 hrs. Excretion in urine (17% in ♂, 17.5% in ♀) and
feces (90% in ♂, 84.5% in ♀) after 72 hours.
Absorption: Glyphosate was slowly and poorly absorbed orally. The absorption half-life was
2.29 hours while the maximal plasma concentration was 4.64 μg/ml and time to maximal
plasma concentration was 5.16 hrs after the oral administration of glyphosate. The oral
bioavailability of glyphosate was 23.21%.
Metabolism: Not extensively metabolized in rats. AMPA was the main metabolite which
represented 6.49% of the parent plasma concentrations.

PMRA#: 2391577
Distribution: After IV administration of 100 mg/kg bw, the distribution phase of glyphosate
was fast (T1/2α = 0.345 hr) and with a high volume of distribution at steady state (Vss = 2.99
L/kg) suggesting extensive distribution in extravascular tissues. The two compartment model
was the best fit for both groups to establish the toxicokinetic characteristics. The values of
apparent volume of distribution in the second compartment were 2.39 and 2.32 L/kg after IV
and oral administration, respectively.

14-Day
Toxicokinetic
(Diet)
Wistar Rat
PMRA#: 1182530
or 1184946

Single Dose
(Gavage)
NZW Rabbits

Elimination: The rate of elimination of AMPA (T1/2β = 15.08 hr) after oral glyphosate
administration was similar to that of glyphosate (T1/2α = 14.38). The elimination half-life
calculated after IV administration was 9.99 hours. The elimination half-life of glyphosate
increased by 44% (to 14.38 hr) after oral administration compared to the IV administration.
Absorption: Poor (based on increased rapid fecal excretion)
Distribution: The body load (= cumulative intake – cumulative excretion) < 5% of the AD for
low and high-dose groups (mid-dose group calculation resulted in a negative value). Maximum
concentration levels reached in tissues by 10th day of exposure. Tissue concentration: kidney,
spleen > fat > liver > ovaries > heart > muscle > brain > testes (the trend in all dose groups).
Excretion: Rate of excretion in urine and feces equalled the rate of intake by day 6-8
(indicating a plateau/steady state level had been reached). Mean urinary excretion was 8.3%,
10.5% and 8.5% of the AD for low, mid- and high-dose groups by the end of the treatment.
Fecal excretion was over 90% of the AD for each dose group. The urinary excretion had
decreased by 96% two days after cessation of the treatment. The fecal excretion was negligible
four days after treatment was stopped.
Metabolism: The major radioactive excreted component was unchanged glyphosate
Distribution: Highest in gut (2.5%) followed by liver, kidney, spleen, heart, muscles, and
gonads.
Excretion: Feces (80 %), urine (7-10%) after 5 days, negligible excretion via air.

PMRA#:
1184958,
1184959
Acute Toxicity Studies
Acute Oral
Toxicity (Gavage)
SPF Mice
PMRA#: 1161775
Acute Oral
Toxicity (Gavage)

LD50 > 2000 mg/kg bw
@ 2000 mg/kg bw: ↑ piloerection and sedation shortly noted after treatment but returned to
normal after 24 hours.
Low acute toxicity
LD50 = 5600 mg/kg bw

Proposed Re-evaluation Decision – PRVD2015-01
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 Appendix III

Study Type/
Animal/ PMRA #
Wistar Rat
PMRA#: 1184851

Acute Oral
Toxicity (Gavage)

Study Results
≥ 2500 mg/kg bw: ↑ piloerection, ↑ lethargy (persisted up to 7 days after dosing), ↑ pale liver
and kidneys (animals which died), ↑ ataxia, ↑ convulsions, ↑ muscle tremors, ↑ red nasal
discharge, ↑ clear oral discharge, ↑ urinary staining of the abdomen, ↑ soft stool, ↑ fecal
staining of the abdomen
Low acute toxicity
LD50 > 5000 mg/kg bw
@ 5000 mg/kg bw: ↑ diarrhea noted on day 2

Wistar Rat
Low acute toxicity
PMRA#: 1161752
Acute Oral
Toxicity (Gavage)

LD50 > 5000 mg/kg bw

Wistar Rats

Low acute toxicity

PMRA#: 1211998
Acute Oral
Toxicity (Gavage)

LD50 > 5000 mg/kg bw
@ 5000 mg/kg bw: 1♀ exhibited laboured breathing on day 4 and 6 after treatment

Wistar Rats
Low acute toxicity
PMRA#: 1874174
Acute Oral
Toxicity (Gavage)
Rabbits

LD50 = 3800 mg/kg bw
≥ 2000 mg/kg bw: ↑ hypoactivity
≥ 3000 mg/kg bw: ↑ mortality, ↑ hemorrhage and ulceration of the stomach

PMRA #:
1184695
Acute Dermal
Toxicity

Low acute toxicity
Supplemental
LD50 > 2000 mg/kg bw

Sprague-Dawley
Rats

@ 2000 mg/kg bw: Piloerection and reduced activity. Scab formation @ the test site 2-14 days
after dosing.

PMRA#: 1161756

Acute Dermal
Toxicity
Wistar Rats
PMRA#: 1211999
Acute Dermal
Toxicity

Low acute toxicity
LD50 > 2000 mg/kg bw
@ 2000 mg/kg bw: One male showed slight erythema on days 2 and 3 and one female had
scabs from days 3 to 8.
Low acute toxicity
LD50 > 2000 mg/kg bw
Low acute toxicity

Wistar Rats
PMRA#: 1874176
Primary Dermal
Irritation

Supplemental

Proposed Re-evaluation Decision – PRVD2015-01
Page 74

 Appendix III

Study Type/
Animal/ PMRA #

Study Results
Non irritating

NZW Rabbit
PMRA#: 1161763
Primary Dermal
Irritation

Non irritating

NZW Rabbit
PMRA#: 1212002
Primary Dermal
Irritation

Non irritating

NZW Rabbit
PMRA#: 1874186
Dermal
Sensitization

Negative

Hartley
Guinea Pig
PMRA#: 2391580
Dermal
Sensitization

Negative

♀ Guinea Pigs
PMRA#: 1161765
Dermal
Sensitization
♀ Guinea Pigs
PMRA#: 1212003
Dermal
Sensitization

@ 75% w/v prep: animals showed scattered mild redness (considered skin irritation)
Negative

Negative

Guinea Pigs
PMRA#: 1874187
Primary Eye
Irritation Study

Unwashed eyes: 5 showed conjunctival redness, one showed chemosis, one eye showed
conjunctival necrosis, one eye showed corneal opacity and ulceration.
Washed eyes: 2/3 show corneal opacity and ulceration, conjunctival redness and chemosis.

Rabbit
The effects cleared by Day 7.
PMRA#: 1184853
Mildly irritating

Proposed Re-evaluation Decision – PRVD2015-01
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 Appendix III

Study Type/
Animal/ PMRA #
Eye Irritation
NZW Rabbit

Study Results
Supplemental

PMRA#: 1161760

One rabbit was tested first and observed 1 hour after instillation. As severe irritation
characterized by conjunctival redness and chemosis, corneal opacity, discharge were noted,
other animals were not tested.

Eye Irritation

Severely irritating
Supplemental

NZW Rabbit

Iritis and moderate conjunctival redness and chemosis

PMRA#: 1161761
Eye Irritation

Moderately irritating
Corneal effects included slight to mild opacity affecting up to the entire cornea (seen in all
animals during first two days).

NZW Rabbit
PMRA#: 1212001

Conjunctival effects included slight to moderate redness, slight to moderate chemosis and
slight to severe discharge noted in all animals up to day 4.
Additional observations included mucoid discharge, eye closed, irregular corneal surface,
convoluted eyelids, and erythema of the upper and/or lower eyelids, raised corneal opacity,
Harderian gland discharge and nictitating membrane partially hemorrhagic.

Eye Irritation

Moderately irritating
Slight conjunctival redness (MIS = 1.67) and chemosis (MIS = 0.67 to 1.33) were observed.

NZW Rabbit

Minimally irritating

PMRA#: 1874178
Acute Inhalation
Toxicity (Head
only)

Supplemental

LC50 > 4.98 mg/L
Sprague-Dawley
Rat
Low acute toxicity
PMRA#: 1161758
Acute Inhalation
Toxicity (Noseonly)
Wistar Rat

LC50 > 4.27 mg/L
≥ 2.43 mg/L: ↑ hunched posture, ↑ piloerection, ↑ wet fur, ↑ breathing irregularities, ↑ reduced
righting reflex, ↑ shaking, ↑ splayed gait
@ 4.27 mg/L: ↑ mortality (2/5 ♂ and 2/5 ♀)

PMRA#: 1212000
Acute Inhalation
Toxicity
(Head only)

Low acute toxicity
LC50 > 2.15 mg/L

Low acute toxicity
Wistar Rat
PMRA#: 1874177

Proposed Re-evaluation Decision – PRVD2015-01
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 Appendix III

Study Type/
Animal/ PMRA #

Study Results
Short-Term Toxicity Studies

90-Day Oral
Toxicity (Diet)

Supplemental

CD-1 Mouse

≥ 935/939 mg/kg bw/day: ↑ incidence of cortical tubular epithelial hypertrophy (adaptive and
not clearly dose-responsive)

PMRA#: 1161787

Parotid and sublingual salivary glands were not examined.

90-Day Oral
Toxicity (Diet)

Collection of small plasma volumes affected hematology and clinical chemistry analysis.
NOAEL = 507 mg/kg bw/day (♂)
NOAEL = 753 mg/kg bw/day (♀)

B6C3F1 Mouse
PMRA#:
2391579

28-Day Oral
Toxicity (Diet)
Sprague-Dawley
Rat
Range-finding

No treatment-related effect on food consumption, sperm counts, morphology and motility, or
estrual cycle length.
≥ 507/753 mg/kg bw/day: ↑ right kidney wt, ↑ lungs wt (♂)
≥ 1065/1411 mg/kg bw/day: ↑ incidence and severity of cytoplasmic alterations of the parotid
salivary gland; ↑ heart wt (♂)
≥ 255/277 mg/kg bw/day: ↑ ALT; ↑ ALP, ↑ phosphate (♂); ↑ mineral deposits at the
corticomedullary junction in the kidneys (2/5 [1 very mild, 1 mild], 2/5 [1 very mild, 1 mild],
4/5 [2 very mild, 2 mild] @ top three doses respectively) (♀)
≥ 1034/1047 mg/kg bw/day: ↓ BWG; ↑ WBC, ↑ lymphocytes (♂); ↓ BW, ↑ ALP, ↓ adrenals
wt (♀)
@ 2592/2614 mg/kg bw/day: ↑ incidence of soft feces , ↓ BW, ↓ adrenals wt (♂); ↓ pChE (♀)

PMRA#: 1161768
28-Day Oral
Toxicity (Diet)
Wistar Rat
Range-finding
PMRA#: 1212041
90-Day Oral
Toxicity (Diet)
F344 Rats
PMRA#: 2391579

Salivary glands were not examined.
≥ 100 mg/kg bw/day: ↓ BW (♂)
≥ 250 mg/kg bw/day: ↑ ALP; ↑ ALT (♂); ↓ urinary pH, ↓ FE (♀)
@ 1000 mg/kg bw/day: ↑ RBC, ↑ platelet, ↑ incidence of hydronephrosis (1/6, 1/6 vs. 0/6); ↓
FC, ↓ FE, ↑ glucose, ↓ abs. brain wt, ↑ rel. testes wt (♂); ↓ BW, ↓ BUN, ↓ kidney wt (♀)

NOAEL = ND
LOAEL = 205 mg/kg bw/day (♂)
LOAEL = 213 mg/kg bw/day (♀)
≥ 205/213 mg/kg bw/day: ↑ ALP, ↓ thymus wt, ↑ incidence and severity of cytoplasmic
alterations of the parotid and submandibular salivary glands
≥ 410/421 mg/kg bw/day: ↑ ALT (♂)
≥ 811/844 mg/kg bw/day: ↑ Hct, ↑ RBC, ↓ sperm counts (10-20%) (♂)
≥ 1678/1690 mg/kg bw/day: ↓ BW, ↓ BWG, ↑ bile acids; ↑ rel. liver wt, ↑ rel. right kidney wt,
↑ rel. right testicle wt, ↑ Hgb (♂)
@ 3393/3939 mg/kg bw/day: ↑ incidence of diarrhea, ↓ FC; ↑ platelet, ↓ abs. heart wt (♂); ↑
lymphocytes, ↑ WBC, ↑ MCH, ↑ MCV, ↑ rel. right kidney wts, ↑ estrous cycle length (5.4 days
vs. 4.9 days) (♀)

Proposed Re-evaluation Decision – PRVD2015-01
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 Appendix III

Study Type/
Animal/ PMRA #
90-Day Oral
Toxicity (Diet)
Sprague-Dawley
Rat

Study Results
NOAEL = ND
LOAEL = 30 mg/kg bw/day (♂)
LOAEL = 31 mg/kg bw/day (♀)
≥ 30/31 mg/kg bw/day: ↑ incidence and severity of cellular alterations of the parotid salivary
gland

PMRA#: 1161777
90-Day Oral
Toxicity (Diet)

NOAEL = 414 mg/kg bw/day (♂)
NOAEL = 1821 mg/kg bw/day (♀)

Wistar Rat

≥ 81/90 mg/kg bw/day: ↑ ALT, ↑ ALP; ↑ prothrombin time, ↓ platelet count (♂) (non-adverse)

PMRA#: 1212004
and 1410983

≥ 414/447 mg/kg bw/day: ↓ platelet count (♀) (non-adverse)

21-Day Dermal
Toxicity

@ 1693/1821 mg/kg bw/day: ↓ BUN; ↓ BW, ↓ BWG, ↓ FE, ↓ triglycerides, ↓ plasma total
protein, ↓ heart wt, ↓ liver wt (♂); ↑ AST (♀)
Salivary glands were not examined.
LOAEL (irritation) = 1000 mg/kg bw/day
LOAEL (systemic) = 1000 mg/kg bw/day

21-Day Dermal
Toxicity

@ 1000 mg/kg bw/day: ↑ very slight erythema (♂: 2/5, ♀: 3/5 during wk 2, only 1/5 ♀
showed this effect during wk 3), ↑ desquamation (♂: 3/5 moderate to severe, ♀: 5/5 mild to
severe during wk 2, 1/5 in each of ♂ and ♀ during wk 3 with mild severity grading; 1/5 ♀
thickening and severe desquamation during wk 3); ↑ unilateral dilatation of the kidneys (2/5 vs.
0/5), ↑ unilateral papillary necrosis (1/5 vs. 0/5), ↑ urothelial hyperplasia (2/5 vs. 0/5), ↑ pelvic
dilation (3/5 [severity grade: +, ++, +++] vs. 0/5) (♂)
NOAEL (irritation) ≥ 1000 mg/kg bw/day
NOAEL (systemic) ≥ 1000 mg/kg bw/day

Wistar Rat

Not systemic or dermal irritation effect

PMRA#: 1212007
21-Day Dermal
Toxicity

NOAEL (irritation) = 1000 mg/kg bw/day
NOAEL (systemic) ≥ 5000 mg/kg bw/day

Sprague-Dawley
Rat
PMRA#: 1161790

NZW Rabbit
PMRA#: 2443653

90-Day Oral
Toxicity (Diet)

No systemic toxicity (no treatment-related effect on BW, hematology, clinical chemistry, organ
weights, or histopathology)
@ 5000 mg/kg bw/day: ↑ slight dermal irritation (erythema and edema on intact and abraded
skin of both sexes); ↓ FC (♀)
Supplemental
No treatment-related effect on BW, hematology, clinical organ weights, or histopathology

Beagle Dog
PMRA#: 1184795
90-Day Oral
Toxicity (Diet)

NOAEL = 323 mg/kg bw/day (♂)
NOAEL = 334 mg/kg bw/day (♀)

Beagle Dog

≥ 68/68 mg/kg bw/day: ↑ abs. adrenals wt, ↑ liver wt (♂) (non-adverse)

PMRA: 1212005

≥ 323/334 mg/kg bw/day: ↑ creatine kinase, ↑ kidneys wt (♂) (non-adverse)
@ 1680/1750 mg/kg bw/day: ↓ BWG; ↓ RBC, ↓ albumin, ↓ total protein, ↓ [Ca++], ↓ [K+] (♂);

Proposed Re-evaluation Decision – PRVD2015-01
Page 78

 Appendix III

Study Type/
Animal/ PMRA #
12-Month Oral
Toxicity
(Capsule)
Beagle Dog
PMRA#: 1161788
12-Month Oral
Toxicity
(Capsule)
Beagle Dog

Study Results
↑ ALP, ↓ ovaries wt (♀)
NOAEL = 30 mg/kg bw/day (♂)
NOAEL = 300 mg/kg bw/day (♀)
≥ 30 mg/kg bw/day: ↓ BW, ↓ BWG, ↑ liver wt (♂)
≥ 300 mg/kg bw/day: ↑ incidence of soft/loose/liquid stool
@ 1000 mg/kg bw/day: ↓ urinary pH; ↑ kidneys wt (♂); ↓ BW, ↓ BWG (♀)
NOAEL = 20 mg/kg bw/day
≥ 100 mg/kg bw/day: ↓ pituitary wt, ↑ lymphoid nodules in epididymis (1/6, 2/6 @ mid and
high dose) (♂); ↑ tubular regeneration of the kidneys (accompanied with presence of epithelial
cells and protein in urine of 1/5 in mid- and high-dose group) (♀)

PMRA #:
1202148
12-Month Oral
Toxicity (Diet)

@ 500 mg/kg bw/day: ↑ testes wt (abs.: 14%, rel.: 13%), ↑ ovaries wt (9%)

Beagle Dog

≥ 90.9/92.1 mg/kg bw/day: ↓ plasma phosphorus, ↑ creatine kinase, ↓ epididymides wt, ↑
transitional epithelial hyperplasia in the kidneys (♂)

PMRA#: 1212006

24-month
Oncogenicity
(Diet)
CD-1 mouse
PMRA #:
1161786,
1161795
26-month Oral
Toxicity and
Oncogenicity
(Diet)
Sprague-Dawley
Rat

NOAEL = 90.9 mg/kg bw/day (♂)
NOAEL = 448 mg/kg bw/day (♀)

@ 906/926 mg/kg bw/day: ↓ BW; ↓ brain wt, ↑ kidneys wt, ↑ thyroid wt (♂); ↓ plasma
phosphorus, ↓ thyroid wt (♀)
Chronic Toxicity/Oncogenicity Studies
NOAEL = 98 mg/kg bw/day (♂)
NOAEL = 102 mg/kg bw/day (♀)
≥ 98/102 mg/kg bw/day: ↓ adrenals wt (♂); ↑ ovaries wt, ↑ thymus wt (♀)(non-adverse)
≥ 297/298 mg/kg bw/day: ↑ incidence of mineral deposits in the brain; ↑ thymus wt, ↑ abs.
lungs wt, ↑ liver wt (♂); ↑ incidence of unilateral foci of tubulostromal hyperplasia in the
ovaries
Equivocal evidence of oncogenicity
NOAEL ≥ 32 mg/kg bw/day (♂)
NOAEL ≥ 34 mg/kg bw/day (♀)
No treatment-related effect on mortality, clinical signs of toxicity, hematology, clinical
chemistry, urinalysis, organ weights, or histopathology. MTD was not reached.
No evidence of carcinogenicity

PMRA#: 1184837
1184838
1184839
24-month Oral
Toxicity and
Oncogenicity
(Diet)

Submandibular gland was examined histologically

Sprague-Dawley
Rat

≥ 362/457 mg/kg bw/day: ↑ inflammation and hyperplasia of squamous mucosa in the
stomach; ↓ and/or absence of sperm in the epididymides, ↑ cell detritus in the duct lumen of the

NOAEL = 89 mg/kg bw/day (♂)
NOAEL = 113 mg/kg bw/day (♀)
No treatment-related effects on clinical signs of toxicity, mortality.

Proposed Re-evaluation Decision – PRVD2015-01
Page 79

 Appendix III

Study Type/
Animal/ PMRA #
PMRA #:
1235214,
1235215

24-month Oral
Toxicity and
Oncogenicity
(Diet)
Sprague-Dawley
Rat
PMRA #s:
1161796,
1161797,
1161798
24-month Oral
Toxicity and
Oncogenicity
(Diet)
Wistar Rat
PMRA #:
1212011,
1212012,
1212013

Study Results
epididymides (♂)
@ 940/1183 mg/kg bw/day: ↓ urinary pH, ↑ abs. and rel. liver wt (interim and terminal sacs),
↑ testes wt (rel. to brain wt), ↑ necrosis in glandular stomach, ↑ myeloid hyperplasia of the
bone marrow (7/50, vs. 3/50), ↑ testicular effects (♂),↑ cataract/lens fiber degeneration; ↓ BW,
↓ BWG, ↑ ALP, ↑ mammary gland hyperplasia (39% vs. 20% [16/58, 19/54, 13/59, 22/57])
(♀)
No evidence of carcinogenicity
Submandibular salivary gland was examined histologically
NOAEL = 10 mg/kg bw/day (♂)
NOAEL = 10 mg/kg bw/day (♀)
≥ 10 mg/kg bw/day: ↓ BW (@ 52 wk), ↓ abs. kidneys wt (@ 52 wk), ↓ abs. liver wt (@ 52
wk), ↑ parotid gland wt (@ wk 52) (♂); ↓ rel. liver wt (@ wk 52) (♀)
≥ 101/103 mg/kg bw/day: ↑ incidence and severity of cellular alteration in the submandibular
and parotid salivary glands @ interim and terminal sacs, ↓ BWG (interim sac animals only); ↑
ALP (3, 6, 12, 18, and 24-month) (♀)
No evidence of carcinogenicity
NOAEL = 361 mg/kg bw/day (♂)
NOAEL = 437 mg/kg bw/day (♀)
≥ 121/145 mg/kg bw/day: ↑ incidence of red-brown staining of tray paper
≥ 361/437 mg/kg bw/day: ↑ ALP, ↑ ALT, ↑ AST (various time-points @ this dose, throughout
all time points at the high dose); ↓ plasma creatinine (wk 27 @ this dose and wk 14 @ high
dose), ↑ incidence of papillary necrosis in the kidneys (♀)
@ 1214/1498 mg/kg bw/day: ↑ incidence of red-brown coloured urine, ↓ BW, ↓ FC, ↓ FE; ↑
total bilirubin, ↓ triglycerides, ↓ cholesterol, ↓ urinary pH, ↑ incidence of transitional cell
hyperplasia in the kidneys, ↑ incidence of papillary necrosis in the kidneys, ↑ incidence of
prostatitis (♂)
No evidence of carcinogenicity
Developmental/Reproductive Toxicity Studies

Two-generation
reproduction
toxicity (Diet)

Parental Toxicity
NOAEL = 685 mg/kg bw/day (♂)
NOAEL = 779 mg/kg bw/day (♀)

Sprague-Dawley
Rat

No treatment-related effect on gross necropsy, and histopathology findings.

PMRA#: 1235339

≥ 685/779 mg/kg bw/day: ↓ BW (non-adverse)
@ 1768/2322 mg/kg bw/day: ↑ soft stools (P & F1), ↓ BW (P♂&♀), ↓ BWG (P & F1); ↓ BW
(all GD periods, and on LD 0, 7, & 14, respectively)
Offspring toxicity
NOAEL = 115/160 mg/kg bw/day (♂/♀)
≥ 685/779mg/kg bw/day: ↓ BW (F2a on LD 21)

Proposed Re-evaluation Decision – PRVD2015-01
Page 80

 Appendix III

Study Type/
Animal/ PMRA #

Study Results
@ 1768/2322mg/kg bw/day: ↓ BW (F1a on LD 21, respectively), ↓ litter size (F1a, F2a, F2b, this
effect was not accompanied with an increase in the dead pups/litter), ↑ tubular dilatation/cysts
in the kidneys (F2b)
Reproductive toxicity
NOAEL = 685 mg/kg bw/day (♂)
NOAEL = 779 mg/kg bw/day (♀)
@ 1768/2322mg/kg bw/day: ↓ litter size (F1a, F2a, F2b, this effect was not accompanied with an
increase in the dead pups/litter)
No treatment-related effects on mating, pregnancy, and fertility indices.
Sperm parameters (motility and morphology), estrous cycle length and periodicity, and ovarian
follicle were not examined.

Two-generation
reproduction
toxicity (Diet)

No sensitivity of the young
Parental Toxicity
NOAEL = 48 mg/kg bw/day (♂)
NOAEL = 59 mg/kg bw/day (♀)

Sprague-Dawley
Rat

≥ 143/179 mg/kg bw/day: ↑ (minimal) hypertrophy of acinar cells with (prominent) granular
cytoplasm in the parotid and submandibular salivary glands

PMRA#: 1161793

Offspring toxicity
NOAEL ≥ 488/595 mg/kg bw/day (♂/♀)
No treatment-related effects on mean litter wt, mean pup wt, preputial separation and vaginal
opening.
Reproduction toxicity
NOAEL ≥ 488/595 mg/kg bw/day (♂/♀)
No treatment-related effects on mating, pregnancy, and fertility indices
Sperm parameters (motility and morphology), estrous cycle length and periodicity, and ovarian
follicle were not examined

Two-generation
reproduction
toxicity (Diet)

No sensitivity of the young
Parental Toxicity
NOAEL = 293 mg/kg bw/day (♂)
NOAEL = 323 mg/kg bw/day (♀)

Wistar Rat

No treatment-related effect on gross necropsy, organ weights, and histopathology findings.

PMRA#:
1212014,
1212015

≥ 293/323 mg/kg bw/day: ↑ scaly tails (P♂ and F1♀); ↑ incidence and severity of luminal
dilatation of the uterus
@ 985/1054 mg/kg bw/day: ↑ rel. liver wt (P), ↑ rel. kidney wt (P) ↑ incidence of transitional
epithelial hyperplasia (F1); ↓ BW (F1♂), ↓ FC (F1♂); ↑ glandular dilatation of uterus (F1),
Offspring toxicity
NOAEL = 99.4 mg/kg bw/day (♂)
NOAEL = 104 mg/kg bw/day (♀)

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 Appendix III

Study Type/
Animal/ PMRA #

Study Results
≥ 293/323 mg/kg bw/day: ↓ BW (F1a♂ on LD 22 at this dose and throughout all LDs @ high
dose, respectively)
@ 985/1054 mg/kg bw/day: ↓ spleen wt (F1a♀, F2a♀), ↓ abs. thymus weight (F1a♂: 11% and
F1a♀: 13%), ↑ incidence of unilateral and bilateral pelvic dilatation of the kidneys (F2a)
Microscopic pathology was not conducted in the offspring.
Reproduction toxicity
NOAEL = 985 mg/kg bw/day (♂)
NOAEL = 323 mg/kg bw/day (♀)
@ 985/1054 mg/kg bw/day: ↑ mean # of estrual cycles (P), ↓ mean estrual cycle length (P, F1)
No treatment-related findings on number of sperm, sperm motility parameters, sperm
morphology, number of oocytes or reproductive performance.

Prenatal
Developmental
(Gavage)
Sprague-Dawley
Rat
PMRA#: 1184726

No sensitivity of the young
Maternal Toxicity
NOAEL = 300 mg/kg bw/day
≥ 1000 mg/kg bw/day: ↑ incidence of hydronephrosis (one in each of mid- and high-dose
groups)
Developmental Toxicity
NOAEL = 1000 mg/kg bw/day
@ 3500 mg/kg bw/day: ↓ BW, ↓ number of viable fetuses/dam, ↑ absent kidneys and ureters
(3 fetuses, 2 litters), ↑ skeletal variants, ↑ incidence of reduced ossification of the sternebrae

Prenatal
Developmental
(Gavage)
Sprague-Dawley
Rat
PMRA#: 1161778

No evidence of malformation or sensitivity of the young
Maternal Toxicity
NOAEL = 300 mg/kg bw/day
≥ 1000 mg/kg bw/day: ↑ noisy respiration, ↓ BWG (started during the 1st two days of
treatment and continued throughout to GD 20)
Developmental Toxicity
NOAEL = 300 mg/kg bw/day
≥ 1000 mg/kg bw/day: ↑ skeletal anomalies, ↑ incidence of wavy ribs/rib distortions

Prenatal
Developmental
(Gavage)

No evidence of malformation or sensitivity of the young
Maternal Toxicity
NOAEL = 500 mg/kg bw/day
@ 1000 mg/kg bw/day: 1/24 total litter resorption (0/24 in other groups)

Wistar Rat
PMRA#: 1212016

Developmental Toxicity
NOAEL = 500 mg/kg bw/day
@ 1000 mg/kg bw/day: ↑ not ossified odontoid (unossified skeletal effect), , ↑ hydroureter
No sensitivity of the young

Proposed Re-evaluation Decision – PRVD2015-01
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 Appendix III

Study Type/
Animal/ PMRA #
Prenatal
Developmental
(Gavage)
NZW Rabbit
PMRA#:
1212017,
1411000

Study Results
Maternal Toxicity
NOAEL = 100 mg/kg bw/day
≥ 100 mg/kg bw/day: ↑ diarrhea: few and no feces, and staining in genital area, ↓ FC, ↓ gravid
uterus weight (non-dose-responsive)
@ 300 mg/kg bw/day: ↓ BW, ↑ post-implantation loss, ↑ early intra uterine deaths
Developmental Toxicity
NOAEL = 175 mg/kg bw/day
@ 300 mg/kg bw/day: ↓ fetal BW, ↑ incidence of partially ossified transverse process 7th
cervical vertebrae, ↑ incidence of unossified transverse process 7th thoracic vertebrae, ↑
incidence of 27th pre-sacral vertebrae, ↑ incidence of partially ossified 6th sternebrae, ↑ manus
score, ↑ pes score

Prenatal
Developmental
(Gavage)
Dutch belted
Rabbit
PMRA#: 1184727

No evidence of malformation or sensitivity of the young
Maternal Toxicity
NOAEL = 75 mg/kg bw/day
≥ 175 mg/kg bw/day: ↑ mortality, ↑ soft stools and diarrhea, one abortion (GD 27)
Developmental Toxicity
NOAEL = 175 mg/kg bw/day
≥ 75 mg/kg bw/day: ↓ fetal BW
@ 350 mg/kg bw/day: ↑ incidence of 27th presacral vertebrae, ↑ incidence of 13th rudimentary
and full ribs, ↑ incidence of unossified sternebra

Prenatal
Developmental
(Gavage)
NZW Rabbit
PMRA#: 1161779

No evidence of malformation or sensitivity of the young
Maternal Toxicity
NOAEL = 50 mg/kg bw/day
≥ 150 mg/kg bw/day: ↑ reduced fecal output, ↑ soft/liquid feces, and ↑ blood on tray, ↓ BWG,
↓ FC
Developmental Toxicity
NOAEL = 50 mg/kg bw/day
≥ 150 mg/kg bw/day: ↑ fetuses with one or more cardiovascular abnormalities
Evidence of malformation
Genotoxicity Studies

In vitro bacterial
gene mutation
assay

Negative
≥ 1.3 mg/plate: Cytotoxicity (± S9)

(Salmonella
Typhimurium)
PMRA#: 1161785

Proposed Re-evaluation Decision – PRVD2015-01
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 Appendix III

Study Type/
Animal/ PMRA #
In vitro bacterial
gene mutation
assay

Study Results
Negative
@ 5000 μg/plate: Cytotoxicity (± S9)

(Salmonella
Typhimurium)
PMRA #:
2391580
In vitro bacterial
gene mutation
assay

Negative
@ 5.0 mg/plate: Cytotoxicity (± S9)

(Salmonella
Typhimurium)
PMRA# 1212019
In vitro bacterial
gene mutation
assay

Negative
≥ 2.5 mg/plate: Cytotoxicity (± S9)

(Salmonella
Typhimurium and
Escherichia Coli)
PMRA# 1212022
Dominant Lethal
Assay

Negative

CD-1 ♂ Mouse
PMRA#: 1184728
In vitro Gene
Mutation Assay,

Negative
@ 22.5 mg/ml: Cytotoxicity (± S9)

CHO cells
PMRA#: 2391580
In Vitro Gene
mutation /
cytogenetics
Assay

Negative

Mouse
Lymphoma Cells
PMRA#: 1161781

Proposed Re-evaluation Decision – PRVD2015-01
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 Appendix III

Study Type/
Animal/ PMRA #
In vitro Gene
mutation /
cytogenetics
Assay
Mouse
Lymphoma Cells
PMRA#: 1212020
In vitro Gene
mutation /
Cytogenetics
Assay
Mouse
Lymphoma Cells
PMRA#: 1212023
In vivo Bone
Marrow
Cytogenetics
Study

Study Results
Positive (@ cytotoxic doses)
≥ 1900 μg/ml (in the presence of metabolic activation): ↑ mutant frequency, total relative
survival range 3-56% (cytotoxicity)
≥ 2400 μg/ml (in the absence of metabolic activation): ↑ mutant frequency, total relative
survival under 10% (cytotoxicity)

Negative
≥ 500 μg/ml (in the presence of metabolic activation): ↓ pH (range of 7.07 to 6.32 @ the top
dose of 2000 μg/ml compared to 7.34 in the control group)
≥ 1000 μg/ml (in the presence of metabolic activation): ↑ cytotoxicity (% relative growth = 5690%)

Negative

Sprague-Dawley
Rats
PMRA#: 2391580
In vivo Bone
Marrow
Cytogenetics
Study

Negative

Sprague-Dawley
Rats
PMRA#: 2391580
In vitro
mammalian cell
cytogenetics /
clastogenicity
assay

Negative
≥ 0.75 mg/plate: ↓ mitotic index (-S9)

Human
lymphocytes
PMRA#: 1212021
In vitro
mammalian cell
cytogenetics /
clastogenicity
assay

Negative
≥ 500 μg/ml: ↑ cytotoxicity (30-47%) – S9
≥ 1500 μg/ml: ↑ cytotoxicity (30-47%) + S9

CHO Cells
PMRA#: 1212025

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 Appendix III

Study Type/
Animal/ PMRA #
In vivo
micronucleus
assay

Study Results
Negative

SPF mice bone
marrow cells
PMRA#: 1161784
In vivo
micronucleus
assay

Negative

CD-1 mouse bone
marrow cells
PMRA#: 1212024
Neurotoxicity Studies
Acute
Neurotoxicity
(Gavage)
Wistar Rat
PMRA#: 1212034

90-Day
Neurotoxicity
(Diet)
Wistar Rats
PMRA#: 1212037

NOAEL = 1000 mg/kg bw/day (♂/♀)
No treatment-related effect on landing foot splay, time to tail flick, grip strength data and
motor activity habituation
≥ 1000 mg/kg bw/day: ↓ motor activity
@ 2000 mg/kg bw/day: ↑ incidence of clinical signs of toxicity/FOB findings (♂: ↑ reduced
splay reflex, ♀: decreased activity, subdued behaviour, hunched posture, sides pinched in, tiptoe gait, reduced splay reflex and/or hypothermia for three females including the one died on
day 2 and diarrhea for one further female 6hrs after dosing and full recovery by day 2,
abnormal respiratory noise in another female on day 2), ↓ FC, ↓ motor activity; one death (♀)
No evidence of neurotoxicity
NOAEL = 617 mg/kg bw/day (♂)
NOAEL = 672 mg/kg bw/day (♀)
≥ 617/672 mg/kg bw/day: ↓ BWG, ↓ FE
@ 1546/1631 mg/kg bw/day: ↑ decreased pupillary response to light, ↓ BW (♂); ↓ BWG, ↓
motor activity (♀)
No evidence of neurotoxicity
Immunotoxicity Studies

28-Day
Immunotoxicity
(Diet)

LOAEL = 150 mg/kg bw/day

B6C3F1 Mouse

≥ 150 mg/kg bw/day: ↑ T-cell dependent antibody response as measured by IgM AFC/106
spleen cells, ↑ total spleen activity as measured by IgM AFC/spleen × 103

No treatment-related effects on spleen or thymus weights (absolute or relative)

PMRA#: 2223081
Evidence of immunotoxicity

Proposed Re-evaluation Decision – PRVD2015-01
Page 86

 Appendix III

Study Type/
Animal/ PMRA #

Study Results
Special Studies (non-guideline)

14-Day Feeding
Mechanistic
Study (Induction
of salivary gland
lesions)
F334 ♂ Rats
PMRA#: 2391579

28-Day Oral
Toxicity Study
(Diet):
Glyphosate Acid:
Comparison of
salivary gland
effects in three
strains of rat

Softer and wetter feces were noted in glyphosate fed groups.
Decrease in body-weight gains in the glyphosate-fed groups was noted compared to the other
groups.
Absolute parotid weight was increased in the group 2 (glyphosate-fed), group 3 (glyphosatefed + propranolol), and group 4 (isoproterenol) compared to group 1 (control). Absolute
submandibular/sublingual was increased in group 2, group 3, and group 4.
Increased incidence of lesions in the parotid gland was observed in the in all groups compared
to group 1 (control). Increased incidence of lesions was also observed in the submandibular
gland of the groups 2 (glyphosate + vehicle) and 3 (glyphosate + propranolol) animals. Parotid
lesions consisted of cytoplasmic basophilic change, fine vacuolation, and swelling of acinar
cells, diagnosed collectively as cytoplasmic alterations. A distinct gradation in the severity of
these lesions was reported which was based on the extent of involvement and degree of
tinctorial alteration and cell enlargement present.
Wistar Rats
@ 1000 mg/kg bw/day: ↓ BW (complete recovery after the 13th week recovery period), ↓ FC,
↑ salivary gland wt, ↑ salivary gland effect (small foci of cells). ↑ mucous metaplasia of parotid
Sprague-Dawley Rats
@ 1000 mg/kg bw/day: ↓ BW (complete recovery after the 13th week recovery period), ↓ FC,
↑ salivary gland effect (small foci of cells).

Wistar Rat
Fischer Rats:
Sprague-Dawley
Rat
Fischer 344
Rat

PMRA #:
1212038

@ 1000 mg/kg bw/day: ↑ salivary gland wt, ↑ pronounced salivary gland effect (diffuse
cytoplasmic basophilia and enlargement of the parotid acinar cells).
Recovery Periods
Complete recovery in Wistar and SD rats starting after 4 weeks of recovery period from
treatment-related effects.
Starting after 4 weeks of recovery period, all treatment-related effects improved, but did not
disappear in F344 rats, (focal changes in the salivary glands and increased salivary gland
weight was evident).

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 Appendix III

Table III.1B

Summary of Toxicology Studies for AMPA

NOTE: Effects noted below are known or assumed to occur in both sexes unless otherwise noted; in such cases,
sex-specific effects are separated by semi-colons. Effects on organ weights are known or assumed to reflect changes
in absolute weight and relative (to bodyweight) weight unless otherwise noted.
Study Type/
Animal/
PMRA #

Study Results
Toxicokinetic Studies

Toxicokinetic
Single dose
(Gavage)
♂ Wister Rats
PMRA# 1184960

Acute Oral
Toxicity

Absorption: Rapid (20%)
Distribution: ≤ 0.01% of dose in most tissue, 0.02% in muscle and gut after 120 hrs (single dose)
Metabolism: None since the compound was excreted in the unchanged form
Excretion: Within 120 hr, 94% of administered dose (AD) was excreted as unchanged
compound. 74% via the feces, 20% via the urine. < 0.1% excreted in the exhaled air, and < 0.06%
was identified in the carcass.
Acute Toxicity Studies
LD50 = 8300 mg/kg bw
Low acute toxicity

Sprague-Dawley
Rats
PMRA#: 2391580
Acute Oral
Toxicity
Wistar rats

LD50 ≥ 5000 mg/kg bw
Clinical signs included diarrhea, stains around the nose, lack of grooming, piloerection, and
urinary incontinence (recover by 3-4 days post dosing).

PMRA# 1212035
Acute Oral
Toxicity (Limit
Dose)
Sprague-Dawley
Rats
PMRA#: 1161753
Primary Eye
Irritation

Low acute toxicity
LD50 > 5000 mg/kg bw
Clinical signs 4h-3days post-dosing included piloerection, diarrhea, subdued behaviour, hunched
appearance, and soiled anal and peri-genital areas.
Low oral toxicity

Minimally Irritating

Rabbits (Albino)
PMRA#: 2391580
Primary Dermal
Irritation

Non irritating

Rabbits (Albino)
PMRA#: 2391580

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 Appendix III

Study Type/
Animal/
PMRA #
Acute Dermal
Toxicity
Sprague-Dawley
Rats
PMRA#: 1161755
Skin Sensitization

Study Results
LD50 > 2000 mg/kg bw

Low dermal toxicity

Negative skin sensitizer

Hartley Guinea
Pig ♀
PMRA#: 1161766
Short-Term Toxicity Studies
28-Day Oral
Toxicity (Gavage)

≥ 350 mg/kg bw/day: ↑ kidney wt (♂)

Range-finding
Sprague-Dawley
Rats
PMRA# 1161791
90-Day Oral
Toxicity (Diet)

NOAEL = 1000 mg/kg bw/day
@ 1000 mg/kg bw/day: ↑ kidney wt (♂); ↓ BWG (♀)

Sprague-Dawley
Rats
PMRA:# 1161769
90-Day Oral
Toxicity (Diet)

NOAEL = 400 mg/kg bw/day

Sprague-Dawley
Rats

≥ 1200 mg/kg bw/day:↑ mucosal hyperplasia of the bladder; ↓ BWG, ↓BW (♂)

PMRA#: 1184722

@ 4800 mg/kg bw/day: ↑ renal pelvic epithelial hyperplasia, ↑ lactate dehydrogenase, ↓ urinary
pH, ↑ urinary calcium oxalate crystals; ↑ cholesterol (♂); ↓ BWG, ↓ BW, ↓ liver wt (♀)

Histopathology
data was available
only for high dose
and concurrent
control
30-Day Oral
Toxicity
(Capsules)
Beagle Dogs

≥ 400 mg/kg bw/day: ↓ liver wt (♂)

NOAEL = 100 mg/kg bw/day
≥ 300 mg/kg bw/day: ↓ RBC, ↓ HGB, ↓ HCT, ↑ reticulocyte count (♀)
@ 1000 mg/kg bw/day: ↓ RBC, ↓ HGB, ↓ HCT, ↑ reticulocyte count (♂)

PMRA# 1126881

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 Appendix III

Study Type/
Animal/
PMRA #
92-Day Oral
Toxicity
(Capsules)

Study Results
NOAEL = 300 mg/kg bw/day
No treatment-related effects. No evidence of anemia.

Beagle Dogs
PMRA# 1126892
1149397
Developmental/Reproductive Toxicity Studies
Prenatal
Developmental
Toxicity Study
(Gavage)

No treatment-related effects.
Supplemental

♀ Rats
Range-Finding
PMRA#: 2391580
Prenatal
Developmental
Toxicity Study
(Gavage)

Parental Toxicity:
NOAEL = 150 mg/kg bw/day
≥ 400 mg/kg bw/day: ↑ hair loss, ↑ soft and mucoid feces

♀ Rats

@ 1000 mg/kg bw/day: ↓ BW, ↓ BWG, ↓ FC

PMRA#: 1126903

Developmental Toxicity:
NOAEL = 400 mg/kg bw/day
@ 1000 mg/kg bw/day: ↓ BW

Prenatal
Developmental
Toxicity

Supplemental

♀ SpragueDawley Rats

No treatment-related effects

PMRA#: 1161794

Parental Toxicity:

Developmental Toxicity:
NOAEL= 350 mg/kg bw/day
@ 1000 mg/kg bw/day: ↑ incidence of ↓ ossification (hyoid bone, skull bones and 2nd
metacarpal) and ↑ skeletal variations (bipartite sternebrae hemicentres and caudal pelvic
shift/asymmetric alignment of pelvic bones)
Genotoxicity Studies

In vitro bacterial
gene mutation
assay

Negative

(Salmonella
Typhimurium and
Escherichia Coli)
PMRA# 1212018

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 Appendix III

Study Type/
Animal/
PMRA #
In vitro bacterial
gene mutation
assay

Study Results
Negative

(Salmonella
Typhimurium and
Escherichia Coli)
PMRA# 1161782
Unscheduled
DNA synthesis
Assay

Negative

Rat hepatocytes
PMRA# 1126905
Micronucleus
Assay

Negative

Mouse
PMRA# 1156204
In vitro Gene
mutation /
cytogenetics
Assay

Negative

Mouse
Lymphoma Cells
PMRA# 1161780
Micronucleus
Assay

Negative

Mouse
PMRA# 1161783

Table III.2

Toxicological Points of Departure for Use in Human Health Risk Assessment
for Glyphosate Acid, AMPA, N-acetyl glyphosate and N-acetyl AMPA
RfD

ARfD (General
Population)

1.0
mg/kg
bw

ARfD (female
13-49 years of
age)

0.5
mg/kg
bw

Study NOAEL (or LOAEL)

NOAEL = 100 mg/kg bw/day
Rabbit developmental toxicity study
(Increased incidence of diarrhea: few/no feces, staining in
genital area.)
NOAEL = 150 mg/kg bw/day (for fetal cardiovascular
malformations)
Rabbit developmental toxicity study
(Increased incidence of fetal cardiovascular malformations.)

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CAF or Target
MOE and
Rationale
CAF = 100
PCPA factor1 =
1-fold
CAF = 300
PCPA factor =
3-fold

 Appendix III

RfD

Study NOAEL (or LOAEL)

NOAEL = 32/34 mg/kg bw/day (♂/♀)
26-month Chronic/Carcinogenicity Study in Rats
(No treatment-related effects were noted in this study. This was
the highest (combined) NOAEL for the long-term toxicity
studies in rats. The lowest (conbined) LOAEL was 100 mg/kg
bw/day based on reduction in body weight in male rats in the
Aggregate (All
interim sacrifice and increased incidences and severity of
Durations and
cellular alterations in the parotid and submandibular glands in a
Populations)
24-month chronic toxicity and carcinogenicity study in rats.
NOAELS/LOAELs are further supported by the NOAEL of 30
and LOAEL of 100 mg/kg bw/day in one-year studies in dogs.)
LOAEL = 30 mg/kg bw/day
Incidental Oral, 0.3
mg/kg
Short-term
90-Day Oral Study in Rats
(Increased incidence and severity of cellular alteration in the
bw/day
Dermal and
parotid gland. This LOAEL was considered to be at the
Inhalation (All
threshold of toxicological adversity due to the mild nature of the
Populations)
cellular alteration in the parotid glands at this dose level. As a
result, an uncertainty factor (UFL) for extrapolating from a
LOAEL to a NOAEL was not deemed necessary.)
0.3
NOAEL = 32/34 mg/kg bw/day (♂/♀)
Intermediate
mg/kg
and Long-term
26-month Chronic/Carcinogenicity Study in Rats
(No treatment-related effects were noted in this study. This was
bw/day
dermal,
the highest (combined) NOAEL for the long-term toxicity
Inhalation, (All
studies in rats. The lowest (combined) LOAEL was 100 mg/kg
Populations)
bw/day based on reduction in body weight in male rats in the
interim sacrifice and increased incidences and severity of
cellular alterations in the parotid and submandibular glands in a
24-month chronic toxicity and carcinogenicity study in rats.
NOAELS/LOAELs are further supported by the NOAEL of 30
and LOAEL of 100 mg/kg bw/day in one-year studies in dogs.)
Low level of concern due to benign nature of tumours observed
Cancer
at the limit dose and lack of oncogenicity in other studies
Assessment
1
PCPA factor = Pest Control Products Act factor
ADI (All
Populations)

0.3
mg/kg
bw/day

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CAF or Target
MOE and
Rationale
CAF/MOE =
100
PCPA factor =
1-fold
Target MOE =
100

Target MOE =
100

Target MOE =
100

 Appendix IV

Appendix IV Dietary Exposure and Risk Estimates for Glyphosate
Table IV.1

Dietary Exposure and Risk Estimates for Glyphosate
MRL/Tolerance-Level
th

Acute Dietary (95 percentile)
Population
Subgroup

Food Only

1

Chronic Dietary2

Food + Water

Food Only

Food + Water

Exposure
(mg/kg/day)

%ARfD

Exposure
(mg/kg/day)

%ARfD

Exposure
(mg/kg/day)

%ADI

Exposure
(mg/kg/day)

%ADI

—

—

—

—

0.090925

28

0.095078

30

All Infants
(< 1 year old)

0.310861

31

0.344347

34

0.125494

39

0.139108

44

Children
1-2 years old

0.435005

44

0.446406

45

0.218341

68

0.224507

70

Children
3-5 years old

0.401028

40

0.411654

41

0.213099

67

0.218872

68

Children
6-12 years old

0.283779

28

0.289644

29

0.147290

46

0.151272

47

Males3
13-19 years old

0.207897

21

0.210659

21
0.090032

28

0.093034

29

0.073547

23

0.077423

24

General
Population

Youth3
13-19 years old
Males3
20-49 years old

0.158854

16

0.176746

18

Adults3
20-49 years old
Adults
50+ years old

0.116579

12

0.123514

12

0.058796

18

0.062875

20

Females
13-49 years old

0.146629

29

0.152714

31

0.068430

21

0.072290

23

1

Acute reference dose (ARfD) of 0.5 mg/kg bw applies to females 13-49 years old; ARfD of 1.0 mg/kg bw applies to population
subgroups other than females 13-49 years old.
2
Acceptable daily intake (ADI) of 0.3 mg/kg bw/day applies to the general population and all population subgroups.
3

Due to a specific ARfD for females 13-49 years old, acute exposure and risk estimates for males 13-19 and 20-49 years old were
calculated separately by using the appropriate ARfD. Acute exposure and risk estimations for youth 13-19 years old and adults
20-49 years were not applicable. This separation was not necessary for chronic exposure and risk estimations as the same ADI
applies to all population subgroups.

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 Appendix IV

 

 

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Appendix V

Appendix V
V.1

Food Residue Chemistry Summary

Metabolism

V.1.1 General Considerations
Previously reviewed comparative studies have shown that there are no significant differences in
the behaviour of aqueous solutions of glyphosate prepared from the acid form (in other words,
technical glyphosate) and the different salts of glyphosate (for example, isopropylamine,
ammonium or trimethylsulfonium salt). In these aqueous solutions, the glyphosate anion (in
other words, the phosphonomethylglycine anion, denoted as PMG) and the cationic counterion
exist as freely dissociated ions. Thus, with regard to the metabolic fate of the PMG moiety, all
the glyphosate forms are considered to be equivalent when using 14C-PMG radiolabelled
material. The metabolism of the counterion is studied by using 14C-counterion labelled test
compound.
V.1.2 Animal Metabolism
Glyphosate
Livestock (goats and hens) metabolism studies were conducted with 14C-PMG or 14C-TMS
labelled glyphosate salts. TMS (trimethylsulfonium) is the cationic group of glyphosate-TMS,
the trimethylsulfonium salt of glyphosate. The studies were previously reviewed and deemed
adequate. It was concluded that the biotransformation and degradation pathways of glyphosate
(the PMG moiety) in the goat and hen are similar, producing essentially unchanged PMG and
aminomethylphosphonic acid (AMPA); these pathways were also found to be similar to those
established in rat metabolism.
N-acetylglyphosate
The metabolism of the metabolite N-acetylglyphosate, which is formed in the glyphosate
N-acetyltransferase (GAT) crops (in other words, crops that were genetically modified to express
the glyphosate N-acetyltransferase gene) treated with glyphosate, was also investigated in goats
and poultry. The studies revealed that the molecule N-acetylglyphosate either remains unchanged
or loses its N-acetyl group, forming parent glyphosate. Parent glyphosate is further metabolized
into AMPA. To a certain extent N-acetyl AMPA was also formed, but was not detected in any
tissue except in fat samples at low levels (average: 0.02 ppm in goat; 0.006 ppm in hen). AMPA
was detected at low levels in milk, liver, fat, muscle and eggs.
V.1.3 Plant Metabolism
Glyphosate
The nature of glyphosate residues in plants has been investigated in a wide range of
non-transgenic (conventional, glyphosate non-tolerant) crops (for example, wheat, grapes,
corn, soybean and lemon) and in transgenic (glyphosate tolerant) crops containing the
5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) gene and/or the glyphosate

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 Appendix V

oxidoreductase (GOX) gene (for example, soybean). The studies indicate that the uptake of
glyphosate from soil is limited. The material that is taken up is readily translocated. Foliar
applied glyphosate is readily absorbed and translocated throughout the trees or vines to the
fruits. Conventional and transgenic crops containing EPSPS and/or GOX genes show a similar
glyphosate metabolic pattern, producing mainly the parent compound (the PMG moiety) and
the metabolite AMPA. However, in glyphosate-tolerant EPSPS/GOX crops, glyphosate was
metabolized more rapidly to AMPA. For the most part, the ratio of glyphosate to AMPA is 9 to 1
but can approach 1 to 1 in a few cases (for example, soybeans and carrots).
N-acetylglyphosate
The metabolic fate of 14C-PMG labelled glyphosate has also been investigated in soybean, corn
and canola plants genetically modified to express the GAT gene. The studies were previously
reviewed and deemed adequate. These studies revealed that, whereas conventional and
glyphosate-tolerant crops containing the EPSPS and/or the GOX genes show a similar metabolic
pattern that consists mainly of parent compound and AMPA, in crops containing the GAT gene,
the major metabolic pathway is different. The parent compound is extensively metabolised to
N-acetylglyphosate; to a lower extent N-acetyl AMPA and AMPA are also formed.
V.1.4 Residue Definition
Based on metabolism studies summarized above, the PMRA has previously determined that the
residue definition (RD) in all conventional crops and in transgenic crops containing the EPSPS
and/or the GOX genes is comprised of glyphosate and the metabolite AMPA. The RD in
genetically modified crops containing the GAT gene (in other words, soybeans, corn and canola)
is the sum of glyphosate and the metabolites N-acetylglyphosate, AMPA and N-acetyl AMPA.
The RD in animal commodities is the sum of glyphosate and the metabolites N-acetylglyphosate
and AMPA. These RDs are used for both enforcement and dietary risk assessment purposes.
No modification to the current RDs is proposed as the result of this re-evaluation, provided it is
understood that all the metabolites included in the RDs are expressed as glyphosate (see Table
VI.1). The residue of concern in drinking water for dietary risk assessment is defined as the sum
of glyphosate and the metabolite AMPA. The acetylated metabolites are not included in the RD
for drinking water because they are not formed in soil, in other words, N-acetylglyphosate is not
applied to plants; it is a metabolite produced in GAT crops as a result of the application of
glyphosate.

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 Appendix V

Table V.1
Transgenic GAT Crops

Residue Definitions
Conventional and
Transgenic EPSPS/GOX
Crops

Residue Definition for Enforcement of MRLs
Sum of glyphosate,
Sum of glyphosate and
N-acetylglyphosate,
AMPA, expressed as
AMPA and N-acetyl
glyphosate1
AMPA, expressed as
glyphosate1

Animal Commodities

Drinking Water

Sum of glyphosate, Nacetylglyphosate and
AMPA, expressed as
glyphosate1

Not applicable

Residue Definition for Risk Assessment
Same as RD for
Same as RD for enforcement
Same as RD for
Sum of glyphosate and
enforcement
enforcement
metabolite AMPA
1
Molecular weight conversion factors (MWCF) for field trial residues: Glyphosate = 0.8 × N-Acetylglyphosate; 1.1
× N-Acetyl AMPA; 1.5 × AMPA.

V.2

Analytical Methods

The analysis of glyphosate and its major metabolites is complicated by the polar nature of the
residues (in other words, insoluble in most organic solvents) and their similarity in properties to
naturally occurring compounds such as amino acids. Nonetheless, several single analyte
analytical methods have been reported for the analysis of residues in plant materials, animal
tissues, milk and eggs. The methods used in field trials were similar to, or the same as those
reported as suitable for enforcement purposes. The methods generally involve aqueous extraction
of residues, typically with dilute acid, clean-up on cation and anion exchange columns,
separation using GC or high performance liquid chromatography (HPLC) and derivatization
prior to detection. The derivatisation reaction varies with the chromatographic method used for
separation (GC, HPLC) and detection system employed (FPD, fluorescence detector, UV, MS or
MS/MS). Satisfactory recoveries at limits of quantitation (LOQs) in the range of 0.025-0.05 ppm
for glyphosate and its major metabolites were reported for numerous commodities. Some of
those analytical methods have been successfully validated for enforcement purposes and are
listed in United States Environmental Protection Agency’s pesticide analytical methods
(PAM)-Volume II or in the index of residue analytical methods (RAM) pending compilation
in PAM-Volume II. Multiresidue methods in PAM-Volume I Appendix I were found to be
inadequate for enforcement purposes and glyphosate is not listed in CFIA’s Volume 7:
Multiresidue Analytical Method Manual.
V.2.1 Supervised Residue Trial Analytical Methodology
Several single analyte analytical methods for the determination of the residues of glyphosate and
its metabolites AMPA and the TMS cation in various plant and animal matrices have been
previously reviewed and deemed adequate. Successfully validated methods are also available for
the determination of glyphosate and its metabolites N-acetylglyphosate, AMPA and N-acetyl
AMPA in GAT-soybean, GAT-corn and GAT-canola and in animal commodities. The analyses
were performed using reverse phase HPLC and a tandem LC-MS/MS system operating with an
electrospray interface (ESI) in positive ion mode detection. The LOQ in each matrix examined
was 0.05 ppm for plant commodities and in the range of 0.025-0.05 ppm for animal
commodities.

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 Appendix V

V.2.2 Enforcement Analytical Methodology
The inter-laboratory validated data collection methods (see Section V.2.1) were determined to be
acceptable for the enforcement of glyphosate MRLs including all the metabolites comprised in
the residue definitions.
V.2.3 Independent Laboratory Validation (ILV)
See Section V.2.1.
V.2.4 Multi-Residue Analytical Methodology (MRM) Evaluation
Data from the Pestrak database (1990 and 2005) indicate that recoveries are not likely for
glyphosate under USFDA PAM I Multiresidue Methods. N-acetylglyphosate was also tested
according to Protocols A, B and C of the PAM I multiresidue methods. The test substance was
not naturally fluorescent according to procedures outlined in Protocol A, and lacked suitable
chromatographic properties according to the procedures outlined in Protocols B and C.
Therefore, the multiresidue methods described in PAM I are not suitable also for the regulatory
analysis of N-acetylglyphosate.
V.3

Food Residues

V.3.1 Storage Stability
V.3.1.1 Storage Stability of Working Solutions in Analytical Methodology
The storage stability of working solutions of glyphosate and its metabolites reported as part of
the analytical methodology studies (see Sections V.2.1, V.2.2 and V.2.3) was deemed adequate.
V.3.1.2 Freezer Storage Stability
Glyphosate, AMPA – Reports on freezer storage stability of glyphosate and AMPA were
previously reviewed for a variety of crops including soybean, soybean straw, wheat grain,
sorghum grain, citrus fruits, grapes and bananas. It was concluded that glyphosate and AMPA
(plant incorporated) appeared to be stable in the crops for the duration of the magnitude of
residue (MOR) studies, which generally did not exceed 48 months. However, it was noted that
the stability of AMPA in spiked samples was more matrix dependent, in other words, the
residues remained stable in corn grain and tomatoes for up to 31 months, in soybean forage for
up to 24 months, in sorghum straw for up to 9 months and in clover for only 6 months.
N-acetylglyphosate, N-acetyl AMPA – When stored at -20ºC, residues of N-acetylglyphosate
were stable for up to 12 months in soybean forage, seed and hay; corn green plant, forage and
grain; and for 23 months in corn stover. Residues of N-acetyl AMPA were stable for at least
18 months in soybean forage, seed, and hay and for up to 23 months in corn green plant, forage,
grain and stover. These stability periods were deemed adequate to support MOR studies.

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 Appendix V

V.3.2 Magnitude of Residue Studies
V.3.2.1 Supervised Residue Trial Studies
Conventional and transgenic EPSPS/GOX crops – All data requirements for the magnitude
of the residue in conventional and in transgenic EPSPS/GOX plants have been evaluated in past
petitions and deemed adequate. The submitted data originated from a number of field trials
conducted side-by-side with different glyphosate salt formulations on numerous crops. The data
support a maximum seasonal rate of 6.2 kg a.e./ha in pre-emergent applications and 0.9 kg
a.e./ha in pre-harvest applications for forage crops (PHI of 3-7 days) and all other crops (PHI of
7-14 days). It was concluded that the magnitude of the residues resulting from application of any
of the formulations was comparable.
Transgenic GAT crops – Data on residues of glyphosate, N-acetylglyphosate, AMPA and
N-acetyl AMPA in transgenic GAT-soybean, GAT-corn and GAT-canola support a combined
maximum pre-emergent + post-emergent seasonal application rate of 6.98 kg a.e./ha and a PHI
of 12-17 days for soybean seeds; 7.22 kg a.e./ha and a PHI of 7 ± 1 days for corn grain; and
2.53 kg a.e./ha and a PHI of 6-8 days for canola seeds.
V.3.2.2 Residue Decline Study
Residue decline studies were conducted concurrently with supervised residue trials. The studies
were previously reviewed and deemed adequate to support the PHIs specified on the labels (see
Section VI.3.2.1 above).
V.3.2.3 Confined Crop Rotation Trial Study
Confined rotational crop studies conducted with conventional, non-transgenic lettuce (leafy
vegetable), wheat (cereal crop) and radish (root vegetable) using 14C-PMG labelled glyphosatetrimesium were previously reviewed.These studies demonstrated similar metabolic pathways in
all the studied secondary crops and showed that very low levels of the test compound were taken
up by the plants. Similarly to the metabolism of glyphosate in primary crops, PMG and AMPA
were the relevant major components of the radioactive residue found in rotational crops. The
remaining radioactivity was largely incorporated into natural plant products. The studies were
deemed adequate to support glyphosate label claims but no plant back intervals (PBIs) were
specified on the labels. The PMRA concluded that, as glyphosate is registered for use as a “prior
to planting” application on all crops (including rotated crops), no further plant back restrictions
are required. Based on the same study, USEPA also concluded that the current language on
glyphosate labels is sufficient with respect to plant back restrictions and that further plant back
restrictions were not necessary.
V.3.2.4 Field Crop Rotation Trial Study
Conclusions from Section V.3.2.3 (above) waive the requirement for a field crop rotation trial
study.

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 Appendix V

V.3.2.5 Processed Food/Feed
Processing studies were reviewed with past petitions for residues of glyphosate and AMPA in
processed fractions of conventional or transgenic EPSPS/GOX soybean (hulls, meal, crude oil,
refined oil, soapstock and aspirated grain fractions), wheat (bran, short, middlings, flour and
aspirated grain fractions), barley (malt and beer), and canola (cake and oil). These crops are
representative of all pre-harvest uses of glyphosate on crops that can be processed (in other
words, soybean, canola, flax, wheat, barley and oats). Processing studies were also previously
reviewed for residues of glyphosate, N-acetylglyphosate, AMPA and N-acetyl AMPA in
processed fractions of transgenic GAT-soybean, GAT-corn and GAT-canola. The use of
experimental processing factors as a refinement was not necessary at this time; default
processing factors were used in the exposure assessment.
V.3.2.6 Residue Data for Crops Used as Livestock Feed
Residue data for crops used as livestock feed have been previously reviewed. The data were used
for the establishment of MRLs in animal commodities.
V.3.2.7 Livestock, Poultry, Egg and Milk Residue Data
Dairy cow, laying hen and swine feeding studies conducted with conventional and/or transgenic
EPSPS/GOX crops have been previously reviewed and deemed adequate to support MRLs for
residues of glyphosate, AMPA and TMS cation in livestock and dairy commodities. As MRLs
for residues of the TMS cation are being proposed for revocation (see Section V.4),
considerations related to this metabolite are not included in this discussion. Given that GAT
crops (soybean, corn and canola) treated with glyphosate may be used as feed, livestock could be
exposed not only to glyphosate and AMPA, but also to the new metabolites typical for these
genetically modified varieties, namely N-acetylglyphosate and N-acetyl AMPA. Therefore, based
on metabolism studies of N-acetylglyphosate in livestock, the residue definition (RD) for both
enforcement and risk assessment of glyphosate residues in livestock has been amended in past
petitions in order to take into account the possible presence of N-acetylglyphosate and N-acetyl
AMPA. As N-acetyl AMPA was found to be a minor component of the residue in animal
commodities, the RD was revised from glyphosate and AMPA, to glyphosate and the metabolites
N-acetylglyphosate and AMPA, expressed as glyphosate. Based on results of livestock feeding
studies conducted with GAT crops, the maximum theoretical dietary burden (MTDB) and
consequently MRLs in livestock commodities were revised to the current status.
V.4

Data Gaps

Sufficient information was available to adequately assess the dietary exposure and risk from
exposure to glyphosate (all registered, equivalent salt formulations). Given that all uses of
glyphosate-TMS were voluntarily discontinued, risk assessments for glyphosate-TMS were not
conducted. No deficiencies were identified in the residue chemistry database from previous
PMRA reviews. No further data are required.

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 Appendix VI

Appendix VI Supplemental Maximum Residue Limit Information,
International Situation and Trade Implications
Maximum Residue Limits (MRLs) may vary from one country to another for a number of
reasons, including differences in pesticide use patterns and the locations of the field crop trials
used to generate residue chemistry data. For animal commodities, differences in MRLs can be
due to different livestock feed items and practices.
VI.1

Canadian MRLs for Food Commodities

MRLs have been specified for residues of glyphosate including the metabolite AMPA in/on
registered conventional and transgenic EPSPS/GOX genes containing crops as well as for
residues of glyphosate including the metabolites N-acetylglyphosate, AMPA and N-acetyl
AMPA in/on transgenic GAT gene containing crops (in other words, corn, canola and soybeans).
MRLs have also been specified for residues of glyphosate including the metabolites Nacetylglyphosate and AMPA in animal commodities. Separate MRLs have been specified for
residues of the TMS cation (resulting from the use of glyphosate-trimesium) in plant as well as in
animal commodities. PMRA’s decision to regulate the TMS cation (detected as dimethyl sulfide
and reported as TMS cation) separately was based on the fact that glyphosate-trimesium
demonstrates a higher toxicity profile than the other glyphosate salts and, contrary to the
counterions of the latter, the TMS cation is not a naturally occurring compound and leaves
residues above the general regulation limit of 0.1 ppm [see Table VI.1]. Residues in/on all other
crops appearing on the registered labels are regulated under Subsection B.15.002(1) of the Food
and Drugs Regulations not to exceed 0.1 ppm (General MRL) for glyphosate (including
metabolites) and 0.1 ppm for the TMS cation. Given that all glyphosate-trimesium (GPT)
containing products have been discontinued, it is proposed that all MRLs for the TMS cation be
revoked.
Table VI.1

Canadian Maximum Residue Limits
MRL (ppm)
Glyphosate
TMS Cation
(Including Metabolites)

Commodity
Oat milling fractions (excluding flour)

35

15

Rapeseeds (canola)

20

10

Dry soybeans

20

13

Oats

15

10

Barley milling fractions (excluding flour)

15

*

Wheat milling fractions (excluding flour)

15

*

Barley

10

15

Sugar beet roots

10

*

Borage seeds

10

*

Cuphea seeds

10

*

Echium seeds

10

*

Gold pleasure seeds

10

*

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 Appendix VI

MRL (ppm)
Commodity

Glyphosate
(Including Metabolites)

TMS Cation

Hare’s ear mustard seeds

10

*

Milkweed seeds

10

*

Mustard seeds (condiment type)

10

*

Mustard seeds (oilseed type)

10

*

Oil radish seeds

10

*

Poppy seeds

10

*

Sesame seeds

10

*

Sweet rocket seeds

10

*

Peas

5.0

3.0

Wheat

5.0

3.0

Beans

4.0

1.0

Dry lentils

4.0

1.5

Flax seeds

3.0

3.0

Field corn, sweet corn kernel plus cob with husks

3.0

*

Kidney of cattle, goats, hogs, horses and sheep

2.0

1.0

Kidney of poultry

2.0

0.1

Asparagus

0.5

*

Liver of cattle, goats, hogs, horses and sheep

0.2

0.5

Liver of poultry

0.2

0.1

Fat of cattle, goats, hogs, horses, poultry and sheep

0.15

*

Eggs

0.08

0.02

Meat of cattle, goats, hogs, horses and sheep

0.08

0.5

Meat of poultry

0.08

0.05

Milk

0.08

0.5

Meet byproducts of cattle, goats, hogs, horses and sheep

*

0.5

All other crops appearing on the registered labels

*

*

* Regulated under Subsection B.15.002(1) of the Food and Drugs Regulations not to exceed 0.1 ppm.

VI.2

International Regulatory Status

United States – In the United States, glyphosate is registered for use on a variety of fruit,
vegetable and field crops as well as for aquatic and terrestrial non-food uses. Glyphosate is
also registered for use on transgenic crop varieties such as canola, corn, cotton, soybeans,
sugar beets and wheat. The registered forms of glyphosate include: glyphosate acid; glyphosate,
isopropylamine salt; glyphosate, ethanolamine salt; glyphosate, sodium salt; glyphosate,
potassium salt; glyphosate, ammonium salt; glyphosate, diammonium salt; and glyphosate,
dimethylammonium salt. Glyphosate-trimesium (GPT, in other words, sulfosate or glyphosateTMS) is not currently included in any pesticide products actively registered in the United States,

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 Appendix VI

and is not, therefore, included in the current USEPA registration review program for glyphosate
active ingredient. With regard to exposure and risk assessment, the USEPA considers all these
active compounds as being equivalent, with glyphosate acid as the common moiety. Tolerances
[see Table VI.2] are currently established under 40 CFR §180.364 for:
a)

Residues of glyphosate, including its metabolites and degradates in/on registered
conventional crops and transgenic EPSPS/GOX crops, resulting from the application of
all registered forms of glyphosate. Compliance with those tolerance levels is to be
determined by measuring only glyphosate (N-[phosphonomethyl] glycine). The USEPA
determined that, based on toxicological considerations, the metabolite AMPA need not be
regulated regardless of levels observed in food or feeds.

b)

Residues of glyphosate, including its metabolites and degradates in/on registered
transgenic GAT crops and in animal commodities, resulting from the application of all
registered forms of glyphosate. Compliance with those tolerance levels is to be
determined by measuring only glyphosate and its metabolite N- acetylglyphosate
calculated as the stoichiometric equivalent of glyphosate. The metabolite Nacetylglyphosate is considered to be equally toxic as glyphosate. The metabolite N-acetyl
AMPA, which is also formed in transgenic GAT crops, was excluded as residue of
concern based on residue and toxicity considerations. However, the USEPA noted that
the decision not to regulate AMPA and N-acetyl AMPA, regardless of levels observed in
foods or feeds, may be revisited during the registration review process.

JMPR/Codex – Codex MRLs have been established in/on a range of plant commodities as
well as in commodities of animal origin (see Table VI.2). The residue definitions (RDs) for
compliance with MRLs are the same as those used by the USEPA for both transgenic GAT
crops (in other words, the RDs exclude the metabolites AMPA and N-acetyl AMPA) and for
conventional and transgenic non-GAT crops (in other words, the RDs exclude the metabolite
AMPA). However, the residue for dietary risk assessment for plant (genetically modified or not)
and animal commodities is defined as the sum of glyphosate, N-acetylglyphosate, AMPA and
N-acetyl AMPA, expressed as glyphosate. This RD is the same as the one used by the PMRA for
both enforcement of MRLs and dietary risk assessment for transgenic GAT crops. Note that for
risk assessment the PMRA excludes the acetylated metabolites from RDs in non-GAT crops
(except corn, soybean and canola) as well as N-acetyl AMPA from RDs in animal commodities.
There are no Codex MRLs for the TMS cation of glyphosate-trimesium.
EU – Glyphosate (including glyphosate-trimesium, in other words, sulfosate or glyphosate-TMS)
has been approved for use in EU countries (in other words, is included in Annex I to Council
Directive 91/414/EEC) until 12/31/15. The residue definitions for enforcement and risk
assessment have recently been amended to accommodate new varieties of genetically modified
(in other words, GAT gene-containing) soybeans and corn imported from the United States. For
enforcement, the RD is expressed as glyphosate per se in all crops including transgenic GAT
crops and in animal commodities. For dietary risk assessment, the RD is expressed as the sum
of glyphosate, N-acetylglyphosate, AMPA and N-acetyl AMPA, calculated as glyphosate for all
plant commodities (including non-GAT crops) as well as for commodities of animal origin. No
special consideration has been given to the TMS cation of glyphosate-trimesium with regard to
the residue definition or MRLs, but a separate risk assessment has been conducted for
glyphosate-TMS. Glyphosate-TMS has a lower ADI compared to the other glyphosate salts.
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 Appendix VI

The residue definitions (see Table VI.3) and tolerance levels or MRLs (see Table VI.2) for a
variety of commodities are not harmonized across the different regulatory jurisdictions.
Table VI.2

Canadian Maximum Residue Limits and International Tolerances /
Maximum Residue Limits for Glyphosate
CAN MRL1 (ppm)

United States
Tolerance2
(ppm)

Codex MRL3
(ppm)

Acerola
Alfalfa fodder

—

—

Alfalfa, seed
Almond, hulls
Aloe vera
Ambarella
Animal feed, nongrass, group 18
Artichoke, globe
Asparagus

—

0.2
400 (Group 18)
0.5
25
0.5
0.2
400
0.2
0.5
0.2
0.2
0.2
0.2
30 (Group 15,
except field
corn, popcorn,
rice, sweet corn,
and wild rice)
30 (Group 15,
except field
corn, popcorn,
rice, sweet corn,
and wild rice)

Commodity

—

Atemoya
Avocado
Bamboo, shoots
Banana

—
—
—
—
—

0.5
—
—
—
—

Barley
10

Barley, bran
—

Barley milling fractions, except flour
Barley straw and fodder, dry
Bean fodder

500
—
—
—
—
—
—
—
—
—
—

0.05**

30 (Group 15)

—

15

—

—

—

—

400

—

—

200

Beans

—

5.0 (Group 6,
except soybean
and dry pea)
10
25
10
10
0.2
1.0
0.2
0.2

10

—

4.0
Beat, sugar

10

Beet, sugar, dried pulp
Beet, sugar, roots
Beet, sugar, tops
Berry group 13
Betelnut
Biriba
Blimbe
Borage, seed

—
—
—
—
—
—

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2.0 (dry)
—
—
—
—
—
—
—
—
—

 Appendix VI

CAN MRL1 (ppm)

United States
Tolerance2
(ppm)

Codex MRL3
(ppm)

—

—

—

0.2
0.2
0.5
0.5
0.2
20
5.0
1.0
0.2
1.5
0.1
1.0
13
5.0
100

—

—

150

0.1

5.0

3.5
210

5.0

—
—

—

40

Cuphea seeds

10

—

—

Custard apple
Date, dried fruit
Dokudami
Durian
Echium seeds

—

0.2
0.2
2.0
0.2

—

10

—

—

—

1.3
0.2
0.2
0.25

—

3.0

—

—

—

—

—

0.5
0.2
0.2
0.2
0.2

10

—

—

—

—

-

0.1
0.2
0.2

—

100

—

Commodity

Breadfruit
Cacao bean, bean
Cactus, fruit
Cactus, pads
Canistel
Canola, seed

—
—
—
—

20

Carrot
Chaya
Cherimoya
Citrus, dried pulp
Coconut
Coffee, bean, green
Corn, field, forage
Corn, field, grain

—
—
—
—
—
—
—

3.0

Corn, field, stover
Corn, fodder, dry
Corn, pop, grain
Corn, sweet, kernel plus cob with husk removed
Cotton, gin byproducts
Cotton, undelinted seed

3.0

—
—
—

Epazote
Feijoa
Fig
Fish
Flax, seed

—
—
—

Fruit, citrus, group 10-10
Fruit, pome, group 11-10
Fruit, stone, group 12
Galangal, roots
Ginger, white, flower
Gold pleasure seeds

—
—
—

Gourd, buffalo, seed
Governor’s plum
Gow kee, leaves

—

Grain, cereal, forage, fodder and straw, group
16, except field corn, forage and field corn and
stover

Proposed Re-evaluation Decision – PRVD2015-01
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—
—
—
—

20 (Rapeseed)
—
—
—
—
—
—
—

5.0
—

—

—
—
—

—
—
—

—
—
—
—

—
—

 Appendix VI

CAN MRL1 (ppm)

Commodity

Grain, cereal, group 15, except field corn,
popcorn, rice, sweet corn and wild rice

Barley: 10
Corn (field and sweet):
3
Oat: 15
Sorghum (grain): 30
Wheat (grain): 5

30 (except corn
and rice)

0.2
300
0.2

500

10

—

—

—

0.2
7.0
0.2
0.2
0.2
0.2
0.2
0.2
200

—

—

Guava
Hare’s ear mustard seeds

—

—

—
—
—
—
—
—
—
—

4.0

Leucaena, forage
Longan
Lychee
Mamey apple
Mango
Mangosteen
Marmaladebox
Mikweed seeds
Mioga, flower
Mustard, seed

Noni
Nut, pine
Nut, tree, group 14

Codex MRL3
(ppm)

30 (Group 15,
except field
corn, popcorn,
rice, sweet corn,
and wild rice)

Grape
Grass, forage, fodder and hay, group 17

Herbs subgroup 19A
Hop, dried cones
Ilama
Imbe
Imbu
Jaboticaba
Jackfruit
Kava, roots
Kenaf, forage
Lentils

United States
Tolerance2
(ppm)

5.0 (Group 6,
except soybean
and dry pea)

—
—

—
—
—
—
—
—
—
—

No Codex MRL
(proposed EU
MRL of 10 or 15
ppm, based on a
single high
residue value of
8.88 ppm whereas
the rest of the
residue trial
values were in the
range 0.5-4.17
ppm)
—

—

200
0.2
0.2
0.2
0.2
0.2
0.2

10

—

—

—

0.2

—

10
(both condiment and
oilseed types)

—

—
—
—
—
—
—

—
—
—

Proposed Re-evaluation Decision – PRVD2015-01
Page 106

—
—
—
—
—
—

—

0.20
1.0
1.0

—
—
—

 Appendix VI

CAN MRL1 (ppm)

Commodity

Oats
15

Oats milling fractions
35 (excluding flour)

United States
Tolerance2
(ppm)
30 (Group 15,
except field
corn, popcorn,
rice, sweet corn,
and wild rice)
30 (Group 15,
except field
corn, popcorn,
rice, sweet corn,
and wild rice)

Codex MRL3
(ppm)

30
(group 15)

-

—

—

100

Oil radish seeds

10

—

—

Oilseeds, group 20, except canola
Okra
Olive
Oregano, Mexican, leaves
Palm heart
Palm heart, leaves
Palm, oil
Papaya
Papaya, mountain
Passionfruit
Pawpaw
Pea hay or pea fodder (dry)

—

—

—

40
0.5
0.2
2.0
0.2
0.2
0.1
0.2
0.2
0.2
0.2

—

—

500

Oat straw and fodder, dry

—
—
—
—
—
—
—
—
—

Peas
5.0
Peas, dry

—

Peanut
Peanut, hay
Pepper leaf, fresh leaves
Peppermint, tops
Perilla, tops
Persimmon
Pineapple
Pistachio
Pomegranate
Poppy seeds

—

Pulasan
Quinoa, grain
Rambutan
Rice, grain
Rice, wild, grain
Rose apple
Sapodilla

—
—
—
—
—
—
—
—

10
—
—
—
—
—
—
—

5.0 (Group 6,
except soybean
and dry pea)
8.0
0.1
0.5
0.2
200
1.8
0.2
0.1
1.0
0.2
7.0
(Subgroup 19B)
0.2
5.0
0.2
0.1
0.1
0.2
0.2

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—
—
—
—
—
—
—
—
—
—

—

5.0
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—

 Appendix VI

CAN MRL1 (ppm)

United States
Tolerance2
(ppm)

Codex MRL3
(ppm)

—

—

—

0.2
0.2
0.2

10

—

—

Shellfish
Sorghum straw and fodder, dry

—

3.0

—

—

—

50

Soursop
Soybean, dry

—

0.2
20 (seed)
100
200
120
0.2
200

—

Commodity

Sapote, black
Sapote, mamey
Sapote, white
Sesame, seed

—

20

Soybean, forage
Soybean, hay
Soybean, hulls
Spanish lime
Spearmint, tops
Spice subgroup 19B

—
—
—
—
—

10
(poppy seeds)

Star apple
Starfruit
Stevia, dried leaves
Strawberry

—

Sugar apple
Sugarcane, cane

7.0

—
—

20
—
—
—
—
—
—
—

—

0.2
0.2
1.0

*

—

—

—
—

0.2
2.0

2.0

Sugarcane, molasses

—

30

10

Sunflower, seed

—

—

7

Surinam cherry
Sweet potato
Sweet rocket seeds

—

0.2
3.0

—

—

10

—

—

—

0.2
1.0
7.0
100
5.0
100
0.2
0.2
0.5
0.2
0.5

—

—

Tamarind
Tea, dried
Tea, instant
Teff, forage
Teff, grain
Teff, hay
Ti, leaves
Ti, roots
Ugli fruit
Vegetable, bulb, group 3-07
Vegetable, cucurbit, group 9
Vegetable, foliage of legume, subgroup 7A,
except soybean
Vegetable, fruiting, group 8-10 (except okra)
Vegetable, leafy, brassica, group 5
Vegetable, leafy, except brassica, group 4

—
—
—
—
—
—
—
—
—
—
—
—
—
—

Proposed Re-evaluation Decision – PRVD2015-01
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0.2
0.1
0.2
0.2

—
—
—

—

—
—
—
—
—
—
—
—
—
—
—
—
—
—

 Appendix VI

CAN MRL1 (ppm)

Commodity

Vegetable, leaves of root and tuber, group 2,
except sugar beet tops
Vegetable, legume, group 6 except soybean and
dry pea
Vegetable, root and tuber, group 1, except carrot,
sweet potato and sugar beet
Wasabi, roots
Water spinach, tops
Watercress, upland
Wax jambu
Wheat

United States
Tolerance2
(ppm)

—

0.2

—

5.0

—
—
—
—
—

5.0

Wheat bran
—

Wheat milling fractions
15 (excluding flour)

0.2
0.2
0.2
0.2
0.2
30 (Group 15,
except field
corn, popcorn,
rice, sweet corn,
and wild rice)
30 (Group 15,
except field
corn, popcorn,
rice, sweet corn,
and wild rice)
30 (Group 15,
except field
corn, popcorn,
rice, sweet corn,
and wild rice)

Codex MRL3
(ppm)
—
—
—
—
—
—
—

30 (Group 15)

20 (unprocessed)

—

Wheat straw and fodder, dry

—

—

300

Yacon, tuber
Edible offal of pigs

—

0.2

—

—

—

0.5

Edible offal of poultry

—

—

0.5

0.08

0.05

0.05**

—

—

—

5.0 (mammalian
except pigs)

—

5.0 (mammalian
except pigs)

Egg
Fat of cattle, goats, hogs, horses, sheep and
poultry
Kidney of cattle, goats, hogs, horses, sheep and
poultry
Liver of cattle, goats, hogs, horses, sheep and
poultry
Meat byproducts of cattle, goats, hogs, horses
and sheep

0.15
2.0
0.2

*

5.0

0.05** (from
mammals other
than marine
mammals)

*

1.0

—

0.08

—

0.05** (from
mammals other
than marine
mammals)

Meat of poultry

0.08

0.10

0.05**

Milk

0.08

—

0.05**

Meat byproducts of poultry
Meat of cattle, goats, hogs, horses and sheep

*Regulated under B.15.002(1) of the Food and Drugs Regulations not to exceed 0.1 ppm.

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 Appendix VI
**At or about the limit of determination.
1
Maximum Residue Limits for Pesticides webpage as of 12/10/13.
2
Electronic Code of Federal Regulations.
3
Codex Alimentarius webpage as of 12/10/13.

Table VI.3

Commodity

Comparison of Residue Definitions derived by Canada, United States,
JMPR/Codex and European Union

Canada

United States

Residue Definition for Enforcement of MRLs/Tolerances
Transgenic
Sum of glyphosate,
Sum of glyphosate
GAT crops
N-acetylglyphosate,
and N-acetylAMPA and N-acetyl
glyphosate, expressed
AMPA, expressed as
as glyphosate1
1
glyphosate
Conventional
Sum of glyphosate
Glyphosate
and transgenic
and AMPA,
EPSPS/GOX
expressed as
crops
glyphosate1
Animal
Sum of glyphosate,
Sum of glyphosate
commodities
N-acetylglyphosate
and N-acetyland AMPA,
glyphosate, expressed
expressed as
as glyphosate1
1
glyphosate
Residue Definition for Risk Assessment
Transgenic
Sum of glyphosate,
GAT crops
N-acetylglyphosate,
AMPA and N-acetyl
AMPA, expressed as
glyphosate1
Conventional
Sum of glyphosate
and transgenic
and AMPA,
EPSPS/GOX
expressed as
crops
glyphosate1
Animal
Sum of glyphosate,
commodities
N-acetylglyphosate
and AMPA,
expressed as
glyphosate1
1

Sum of glyphosate
and N-acetylglyphosate, expressed
as glyphosate1

JMPR/Codex

European Union

Same as United
States

Glyphosate

Same as United
States

Same as United
States

Sum of glyphosate,
N-acetylglyphosate,
AMPA and N-acetyl
AMPA, expressed as
glyphosate1

Same as
JMPR/Codex

Glyphosate

Sum of glyphosate
and N-acetylglyphosate, expressed
as glyphosate1

Molecular weight conversion factors (MWCF) for field trial residues: glyphosate = 0.8 × NAcetylglyphosate; 1.1 × N-Acetyl AMPA; 1.5 × AMPA.

Proposed Re-evaluation Decision – PRVD2015-01
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 Appendix VII

Appendix VII Agricultural Mixer/Loader/Applicator and Postapplication
Risk Assessment
Table VII.1
Application
Equipment

Scenario

Commercial Mixer/Loader/Applicator Exposure and Risk Assessment
Max.
Rate

Area
Treated
per Day

Dermal
Exposure1
(mg/kg
bw/day)

Inhalation
Exposure2
(mg/kg
bw/day)

Dermal
MOE3

Inhalation
MOE3

Combined
MOE4

Baseline PPE: Open M/L, Single Layer
Groundboom
4.320
360
MLA
0.060848
0.046294
490
650
280
(custom)
kg/ha
ha/day
ML
0.059208
0.046310
510
650
280
4.320
536
Aerial
kg/ha
ha/day
A
0.011184
0.002026
2700
15000
2300
4.320
20
Airblast
MLA
0.037988
0.007992
790
3800
650
kg/ha
ha/day
Mechanically
0.0096
3800
pressurized
MLA
0.101879
0.068856
290
440
180
kg/L
L/day
handgun
0.022
150
Backpack
MLA
0.008822
0.002515
3400
12000
2600
kg/L
L/day
Cut stump
0.36
150
MLA
0.025471
0.030510
1200
980
540
application
kg/L
L/day
ROW
0.0096
3800
MLA
0.016848
0.003010
1781
9968
1511
Sprayer
kg/L
L/day
M/L = mix/load, A = apply, ATPD = area treated per day, MOE = margin of exposure, ROW = right-of-way
1
Dermal exposure (mg/kg bw/day) = (dermal unit exposure × ATPD × maximum application rate × 4% dermal
absorption)/80 kg body weight
2
Inhalation exposure (mg/kg bw/day) = (inhalation unit exposure × ATPD × maximum application rate)/80 kg
body weight
3
Based on a NOAEL of 30 mg/kg bw/day, target = 100
4
Combined MOE = 1/[1/dermal MOE + 1/inhalation MOE]

Table VII.2

Mixer/Loader Tree Injection Exposure and Risk Assessment

Amount
Inhalation
Handled
Dermal Dose
Dermal
Inhalation
Combined
Dose
per Day
(mg/kg/day)3
MOE5
MOE5
MOE6
4
(mg/kg/day)
2
(kg a.i.)
Baseline PPE: Open M/L, single layer
Injection
0.0364
0.1456
3.46 × 10-6
2.91 × 10-6
8700000
10000000
4700000
MOE = margin of exposure
1
Maximum application rate: 0.182 g/5 cm depth breast height (dbh) = 0.0364 g per cm depth breast height (dbh).
2
Amount handled per day: 0.0364 g/cm × 20 cm (max dbh) × 200 (maximum number of trees treated per day) ×
0.001 (g to kg conversion).
3
Dermal Exposure (mg/kg bw/day) = (Amount handled per day (kg) × Dermal Unit Exposure (µg/kg a.i.) × 4%
dermal absorption)/80 kg body weight.
4
Inhalation Exposure (mg/kg bw/day) = (Amount handled per day (kg) × Inhalation Unit Exposure (µg/kg a.i.))/80
kg body weight.
5
Based on a NOAEL of 30 mg/kg/day, target MOE = 100.
6
Combined MOE = 1/[1/dermal MOE + 1/inhalation MOE.
Application
Equipment

Max
Rate
(g/cm)1

Proposed Re-evaluation Decision – PRVD2015-01
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 Appendix VII

Table VII.3

Crop

Commercial Postapplication Exposure and Risk Assessment
TC1
(cm2/hr)

Activity

Rate
(kg
a.i./ha)

Number of
Applications per
Year

Interval
Between
Applications
(Days)

MOE2
(Day 0)

REI3

USC 4

Forestry

USC 7
Canola
(Roundup
ready) seed
production
USC 13
Pearl Millet
Forage grasses
and legume

Pasture

Apple

Weeding (hand),
grading/tagging
Transplanting
Scouting
Irrigation (hand
set)

100
230
580

4700
4.320

2

7

1750

2000
810
270

Scouting

1100

Weeding (hand)
Scouting
Weeding (hand)
Scouting
Irrigation (hand
set)
Scouting
Irrigation (hand
set)
Weeding (hand),
orchard
maintenance
Transplanting
Scouting

70
1100
70
1100

0.902

2

5

4.320

3

7

4.320

4

7

230
580

1800
700

Weeding (hand)
Scouting (full
foliage)
Irrigation
(hand set)
Scouting

70

5500

1750

1900

5800
370
5500
350

12 hours

12 hours

12 hours

220

1100
1750

12 hours

430
4.320

2

7

4.320

3

7

100

2670

12 hours

4100
12 hours

USC 14

Corn (sweet)

Dry Beans
Lentils
Sorghum

Asparagus

1100

4

7

350

1750

220

1100

330

Irrigation
(hand set)

1750

Weeding (hand)
Scouting
Weeding (hand)
Scouting
Weeding (hand)
Scouting
Transplanting

70
1100
70
210
70
210
230

Irrigation (hand
set)

4.320

4.320

6

7

4.320

3

7

4.320

3

7

4.320

3

7

1750

Proposed Re-evaluation Decision – PRVD2015-01
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210
5800
370
5800
1900
5800
1900
1800

12 hours

12 hours

12 hours
12 hours

12 hours
230

 Appendix VII

Crop

TC1
(cm2/hr)

Activity

Rate
(kg
a.i./ha)

Number of
Applications per
Year

Interval
Between
Applications
(Days)

MOE2
(Day 0)

USC 14 (continued)
Weeding (hand)
Scouting
Ginseng
Transplanting

70
210

Irrigation (hand
set)

1750

1300

Weeding (hand)

70

5500

Scouting

210

Transplanting
Transplanting
Scouting,
weeding (hand),
bird/frost control
Irrigation (hand
set)
Weeding (hand)
Scouting
Irrigation (hand
set)
Weeding (hand)
Transplanting
Scouting
Transplanting
Scouting,
Weeding (hand),
Bird control
Irrigation
(hand set)
Orchard
maintenance
Transplanting
Scouting
Orchard
maintenance,
weeding (hand)
Transplanting

230
230

Strawberry

Blueberry
(highbush)

Blueberry
(lowbush)

Cranberry

Grapes

Filberts or
Hazelnuts

Walnut,
Chestnut,
Japanese
heartnut
USC 7, 13, 14
Soybeans (and
GPS tolerant
soybeans

230

640

32000
11000
0.902

4.320

2

4

7

7

9800

1800

4.320

3

7

640
230

70
1100

5800
370

4.320

3

7

1750

640

4.320

2

7

4.320

3

7

580

Weeding (hand)

70

12 hours

6700
2000
430
1800
640

12 hours

12 hours

4100
4.320

3

7

100

Scouting

12 hours

230

100

230

12 hours

230

1750

230
580

12 hours

1700
1800

1750

70
230
1100
230

REI3

1800
700

12 hours

4700
4.320

2

7

2000

12 hours

810

5200
4.320

6

7

1100

Canola (and
GPS tolerant
canola)

Scouting

1100

4.320

5

7

340

12 hours

Flax

Scouting

1100

4.320

3

7

370

12 hours

Proposed Re-evaluation Decision – PRVD2015-01
Page 113

330

12 hours

Scouting

 Appendix VII

Crop

TC1
(cm2/hr)

Activity

USC 7, 13, 14 (continued)
Weeding (hand)
Corn (and GPS
Scouting
tolerant corn)
Irrigation (hand
set)
Weeding (hand)
Scouting
Mustard
(yellow/white,
Transplanting
brown, oriental) Irrigation (hand
set)
Weeding (hand),
thinning
Sugar Beets
Scouting
Scouting
Summer Fallow Irrigation (hand
set)
USC 13, 14
Weeding (hand)
Wheat, Barley,
Oats
Scouting

Rye

Peas
Sugar beets
(Roundup
ready)
Chickpeas,
Lupin (dried),
Fava bean
(dried)
Apricot, Cherry
(sweet/sour),
Peaches,
Plums, Pears
USC 16
Non-cropland
and industrial
uses
Recreational
and
public areas

70
1100

4

7

MOE2
(Day 0)

13000
830

70
210
230

5800
1900
1800

4.320

3

7

1750
70

1750

4.320

3

7

1100
70
1100

4.320

1

n/a

4.320

4

7

0.902

1

n/a

4.320

3

7

5800

12 hours

400

12 hours

350
48000
3000
5800
370

12 hours

12 hours

12 hours

230
0.902

4

10

210
70
1100

31000

12 hours

10000
5800
370
4.320

3

7

1750

12 hours
230

100
4.320

3

4100

12 hours

1800
700

12 hours
12 hours

7

230
580
1100
1750

12 hours

5500

1750
70

12 hours

1900
630

70
1100

REI3

230

210
1100

Scouting
Weeding (hand)
Scouting
Irrigation (hand
set)
Weeding (hand),
thinning
Scouting
Weeding (hand)
Scouting

Scouting
Irrigation (hand
set)

Interval
Between
Applications
(Days)

520

70

Orchard
maintenance,
propping, bird
control, weeding
(hand)
Transplanting
Scouting

1.800

Number of
Applications per
Year

1750

Weeding (hand)

Irrigation (hand
set)

Rate
(kg
a.i./ha)

370
4.320

3

See residential assessment

Proposed Re-evaluation Decision – PRVD2015-01
Page 114

7

230

12 hours

 Appendix VII

Crop

Activity

TC1
(cm2/hr)

Rate
(kg
a.i./ha)

Number of
Applications per
Year

Interval
Between
Applications
(Days)

MOE2
(Day 0)

REI3

USC 4, 27
Shelterbelts,
All activities
230
1700
Nursery stock,
except irrigation
Woody
4.320
4
7
12 hours
ornamentals,
Irrigation (hand
short rotation
1750
220
set)
intensive
culture
USC 30
Turf (prior to
establishment
Scouting
1000
4.320
2
7
18000
12 hours
or renovation)
USC = use site category, REI = restricted entry interval.
Since no DFR or TTR studies were submitted, a peak default DFR value of 25% or a peak default TTR value of
10% of the application rate were used.
1
TC = transfer coefficient. Values from PMRA memo (PMRA, 2012d).
2
Based on an oral NOAEL of 30 mg/kg bw/day and a target MOE of 100.
3
If the target MOE is met, the minimum REI for agricultural uses was set at 12 hours.

Proposed Re-evaluation Decision – PRVD2015-01
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 Appendix VII

 

 

Proposed Re?evaluation Decision PRVD2015-01
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Appendix VIII

Appendix VIII
Table VIII.1
Application
Equipment

Maximum
Application
Rate1

Non-Occupational Risk Assessment
Adult Short-Term Residential Applicator Exposure
2

ATPD

Unit Exposure
(mg/kg a.i. Handled)

Dermal Inhalation
Lawns and Turf: Liquid Product (Adult)
Manually
18.927
pressurized 28 g a.i./L
138.89
0.04
L/day
handwand
18.927
Backpack
28 g a.i./L
286.60
0.31
L/day
Sprinkler
0.700 g
93
29.54
0.049
can
a.i./m2
m2/day
RTU –
Trigger5
28 g a.i./L
187.61
0.13
pump
L/day
sprayer
Gardens and Trees: Liquid Product (Adult)
Manually18.93
pressurized 28 g a.i./L
138.89
0.04
L/day
handwand
18.93
Backpack
28 g a.i./L
286.60
0.31
L/day
Sprinkler
18.93
28 g a.i./L
127.87
0.0031
can
L/day
RTU –
Trigger10
28 g a.i./L
187.61
0.13
pump
L/day
sprayer

Exposure3
(mg/kg bw/day)

Dermal
3.68x102

7.59x102

9.62x10

-

4

1.31x102

3.68x102

7.60x102

3.39x102

2.63x102

MOE4

Combined
MOE5

Inhalation

Dermal

Inhalation

2.65x10-4

820

110000

820

2.05x10-3

400

15000

400

3.99x10-5

31000

750000

31000

2.28x10-4

2300

130000

2300

2.65x10-4

820

110000

820

2.05x10-3

400

15000

400

2.05x10-5

890

1500000

890

4.55x10-4

1100

66000

1100

ATPD = area treated per day; MOE = margin of exposure.
Homeowner PPE consists of: short-sleeved shirt, shorts, and no gloves.
1
Application rate was provided as 0.7 g a.i./m2. This value was converted to g ai/L using a spray volume of 0.025
L/m2 (PMRA, 2012).
2
Default values from USEPA Residential SOP (USEPA, 2012). For lawns and turf RTU-trigger-pump sprayer the
default value is 1 container/day and for gardens and trees RTU-trigger-pump sprayer the default value is 2
containers/day. The largest container size of 5 L was used in the risk assessment.
3
Exposure (mg/kg bw/day) = (Unit exposure (mg/kg a.i.) × ATPD × maximum application rate × 4% dermal
absorption factor)/BW (80kg for adults).
4
Based on a dermal NOAEL of 30 mg/kg bw/day , target MOE is 100.
5
Calculated using the following equation: Combined MOE = 1/(1/dermal MOE + 1/inhalation MOE).

Proposed Re-evaluation Decision – PRVD2015-01
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 Appendix VIII

Table VIII.2 Adult, Youth and Children Short-term Postapplication Exposure and Risk
Assessments on Lawns and Turf
TC1
Duration
(cm2/hr)
(Hours)
1 Application of Glyphosate
High-Contact Lawn Activities
Adult
180000
1.5
Youth
148000
1.3
Children (1 to < 2)
49000
1.5
Mowing Turf
Adult
5500
1.0
Youth
4500
1.0
2 Applications of Glyphosate (7-day interval)
High-Contact Lawn Activities
Adult
180000
1.5
Youth
148000
1.3
Children (1 to < 2)
49000
1.5
Mowing Turf
Adult
5500
1.0
Youth
4500
1.0
Scenario

Dermal Exposure2
(mg/kg bw /day)

Dermal MOE3

0.0945
0.0945
0.1871

320
320
160

0.0019
0.0022

16000
14000

0.1397
0.1397
0.2766

220
220
110

0.0028
0.0033

11000
9200

TC = transfer co-efficient; BW = Body Weight (80 kg for adults, 57 kg for youth, and 11 kg for children [1 to < 2
years old]).
1
Transfer coefficient are based on the USEPA Residential SOPs (USEPA, 2012). Transfer coefficients based on a
body weight of 80 kg were scaled for the surface area of youth and children (1 to < 2 years old) using the correction
factors of 0.82 and 0.27 respectively.
2
Dermal Exposure (mg/kg bw/day) = (TTR (µg/cm2) × TC (cm2/hr) × Duration × DA (4%))/BW (kg).
3
Adult, youth and children short-term MOEs are based on a NOAEL of 30 mg/kg bw/day with a target of 100.

Table VIII.3 Adult, Youth and Children Short-term Postapplication Exposure and Risk
Assessments on Golf Course Turf
TC1
Duration
(cm2/hr)
(Hours)
1 Application of Glyphosate
Postapplication Exposure to Golf Course Turf
Adult
5300
4
Youth
4400
4
Children (6 to < 11)
2900
4
2 Applications of Glyphosate (7-day interval)
Postapplication Exposure to Golf Course Turf
Adult
5300
4
Youth
4400
4
Children (6 to < 11)
2900
4
Scenario

Dermal Exposure2
(mg/kg bw /day)

Dermal MOE3

0.0074
0.0086
0.0102

4000
3500
3000

0.0110
0.0128
0.0150

2700
2300
2000

TC = transfer co-efficient; BW = Body Weight (80 kg for adults, 57 kg for youth, and 32 kg for children [6 to < 11
years old]).
1
Transfer coefficient are based on the USEPA Residential SOPs (USEPA, 2012). Transfer coefficients based on a
body weight of 80 kg were scaled for the surface area of youth and child (6 to < 11 years old) using the correction
factors of 0.82 and 0.55 respectively.
2
Dermal Exposure (mg/kg bw/day) = (TTR (µg/cm2) × TC (cm2/hr) × Duration × DA (4%))/BW (kg).

Proposed Re-evaluation Decision – PRVD2015-01
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 Appendix VIII
3

Adult, youth and children short-term MOEs are based on a NOAEL of 30 mg/kg bw/day with a target of 100.

Table VIII.4 Incidental Oral Exposure Estimates and MOEs for Hand-to-Mouth Transfer
to Children
Hand Residue
(mg/cm2)1
1 Application of Glyphosate (7-day TWA)
Liquid
Lawns/Turf
0.0077
2 Applications of Glyphosate (7-day interval)
Liquid
Lawns/Turf
0.0152
Formulation

Surface

Oral Dose
(mg/kg bw/day)2

MOE3

0.0732

410

0.1451

210

TWA = time weighted average.
1
Fraction of residue on the hands (mg/cm2) is the residue available for transfer.
2
Where Oral Dose (mg/kg bw/day) = [Hand Residue (mg/cm2) × (Fraction of hand mouthed/event (0.06) × Surface
Area of one hand (150 cm2)) × (Exposure Time (hr) × Replenishment Intervals (4/hr)) × (1 – (1 – Saliva Extraction
Factor (0.48)) Number events per hour (13.9)/Replenishment Intervals (4/hr))]/ Body Weight (11 kg).
3
MOE = margin of exposure; For children (1 to < 2 years old), the short-term MOE was based on a NOAEL of
30 mg/kg bw/day with a target of 100.

Table VIII.5 Incidental Oral Exposure Estimate and MOE for Object-to-Mouth Transfer
to Children
Object Residue
(mg/cm2)1
2 Applications of Glyphosate (7-day Interval)
Liquid
Lawns/Turf
1.034
Formulation

Surface

Oral Dose
(mg/kg bw/day)2

MOE3

0.0043

7000

1

Where Object Residue (µg/cm2) was calculated using the TTR equation. 2 applications of glyphosate with a 7 day
interval were assumed.
2
Where Oral Dose (mg/kg bw/day) = [Object Residue (µg/cm2) × 0.001 mg/µg × Surface Area Object Mouthed (10
cm2/event) × (Exposure Time (hr/day) × Replenishment Intervals (4/hr)) × (1 – (1 – Saliva Extraction (0.48))
Number of object-to-mouth events (8.8/hr)/Replenishment Intervals (4/hr))]/ Body weight (11 kg).
3
MOE = margin of exposure; for children (1 to < 2 years old), short-term MOE was based on a NOAEL of 30
mg/kg bw/day with a target of 100.

Table VIII.6
Crop
Forestry4

Non-cropland
and Industrial
Uses5

Bystander Exposure and Risk Assessment
Activity
Hiker – Adult
Hiker – Youth
Hiker – Child
(6 to < 11 years old)
Hiker – Adult
Hiker – Youth
Hiker – Child
(6 to < 11 years old)

TC1
(cm2/hr)
580
476

Dermal Exposure2
(mg/kg bw/day)
0.0093
0.0107

MOE3
(Day 0)
3200
2800

319

0.0127

2400

580
476

0.0107
0.0123

2800
2400

0.0147

2000

Rate
(kg a.i./ha)
4.320

4.320

319

1

TC = transfer coefficient. Value is based on scouting in an orchard. Values from PMRA memo (PMRA, 2012d).
Since no DFR or TTR studies were submitted, a peak default DFR value of 25% of the application rate was used.
3
Based on an oral NOAEL of 30 mg/kg bw/day and a target MOE of 100.
4
Based on 2 applications per year with a 7 day interval.
5
Based on 3 applications per year with a 7 day interval.
2

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 Appendix 

 

 

Proposed Re?evaluation Decision PRVD2015-01
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Appendix IX

Appendix IX Aggregate Risk Assessment
Table IX.1

Population

Aggregate Risk Assessment

M/L/A Scenario

Lawns and Turf Scenario
Manually
pressurized
handwand
Backpack
Sprinkler can
Trigger pump
sprayer
Manually
Adult
pressurized
handwand
Backpack
Sprinkler can
Trigger pump
sprayer
—

High
Contact
Lawn
Activities

Incidental Oral
Exposure
(mg/kg bw/day)

0.1316
0.1725
0.0955
0.1079

Total Exposure
(mg/kg
bw/day)4

Aggregate
MOE5

—

0.1692

190

—
—
—

0.2102
0.1332

150
240

0.1455

220

0.0767

420

—
—
—

0.1176
0.0406

270
790

0.0530

600

—
—

0.0451

710

0.1493

210

0.0570
0.0634

560
500

0.0917

350

—

Mowing

0.0799
0.0029
0.0153
0.0074

—
—

0.0022
0.0086

—
—

—

Golfing

0.0102

—

Youth

Chronic Dietary
Exposure
(mg/kg bw/day)3

0.0377

0.0390

Golfing
High
Contact
Lawn
Activities
Mowing
Golfing

—

Children
(6 to < 11)

PA
Scenario1

Total Dermal +
Inhalation
Exposure
(mg/kg
bw/day)2

0.0945
0.0548

Proposed Re-evaluation Decision – PRVD2015-01
Page 121

0.0815

 Appendix IX

Population

Children
(1 to < 2)

M/L/A Scenario

PA
Scenario1

Total Dermal +
Inhalation
Exposure
(mg/kg
bw/day)2

—

High
Contact
Lawn
Activities

0.13946

Incidental Oral
Exposure
(mg/kg bw/day)

Chronic Dietary
Exposure
(mg/kg bw/day)3

Total Exposure
(mg/kg
bw/day)4

Aggregate
MOE5

0.07326

0.1125

0.3251

98

M/L/A = Mixer, Loader, Applicator; PA = postapplication.
1
Based on 1 application of glyphosate.
2
Total Dermal + Inhalation Exposure (mg/kg bw/day) = Sum of Dermal and Inhalation Exposures from Handler and Postapplication Scenarios (See
Tables III.1 to III.4).
3
See Section 3.5.2.
4
Total Exposure (mg/kg bw/day) = (Total Dermal + Inhalation Exposure) + Incidental Oral Exposure + Chronic Dietary Exposure.
5
Based on an oral NOAEL of 32 mg/kg bw/day and a target MOE of 100.
6
1 application of glyphosate along with a 7-day time-weighted DFR average was used (the average residues of glyphosate were calculated over a 7-day
span) for this lifestage (see Table III.5).

Proposed Re-evaluation Decision – PRVD2015-01
Page 122

 Appendix X

Appendix X
Table X.1

Property

Environmental Fate, Toxicity and Risk Assessment of Glyphosate

Fate and Behaviour of Glyphosate, Its Transformation Product AMPA and the Formulant POEA in the
Terrestrial Environment
Test
Substance

Glyphosate
Phototransfor
mation in soil
AMPA

Phtotransform
ation in air

Aerobic soil
biotransformat
ion (nonsterile soils)

Material
Sandy loam, pH7.6, O.M. 1.6%. 22.2ºC
Ray siltt loam, pH 8.2, O.M. 1.2%
Les Evouettes silt loam, pH 6.1, O.M. 2.4%
Visalia sandy loam, pH 8.3, O.M. 0.6%
California sandy loam

Glyphosate

NR

AMPA

NR

Glyphosate

Rep
Major
Kinetic
t1/2
Transf.
Comments 1
Models
(days)
Prod.
90.2 (96.3 dark)
NR
NR
SFO
None
Not a major route
45.0
NR
NR
SFO
None
of transformation
402.0
NR
NR
SFO?
None
in the
6.5 (6.6 dark)
NR
NR
SFO
AMPA
environment
AMPA was detected at 19.9% AR and 24% AR in irradiated and dark samples at study
termination from exposition of glyphosate to sunlight. The presence of AMPA was linked
to microbial activity rather than photolytic process. Phototransformation is unlikely to be
major route of dissipation
Glyphosate is considered to be non-volatile, having a very low vapour pressure and low
Henry’s law constant. Photransformation is not expected to be a major route of
transformation
Glyphosate is unlikely to be volatile since it is formed in soil and bind strongly to soil
particles. Photransformation is not expected to be a major route of transformation
DT50 (Days)

DT90
(Days)

Lab dissipation
Drummer silty clay loam, pH 6.2, O.M. 5.6%
Spinks sandy loam, pH 4.7, O.M. 2.3%

15.4-16.8
11.2-14.7

NR
NR

NR
NR

NR
NR

AMPA
AMPA

Aerobic biotransformation
Drummer silty clay loam, pH 7.0, O.M. 6.0%
Ray silt loam, pH 6.5, O.M. 1.0%
Norfolk sandy loam, pH 5.7, O.M. 1.0%
Kickapoo sandy loam, pH 7.3, O.M. 2.8%
Dupo silt loam, pH 7.5, O.M.1.0%
Les Evouettes II silt loam, pH 6.1, O.M. 2.4%
Visalia sandy loam, pH 8.3, O.M. 0.6%
Washington sandy loam, pH 8.2, O.M. 1.2%
Sandved, Denmark, pH 6.5, O.M.2.7%
Lorraine sandy loam, pH 5.1, O.M. 1.4%
Lorraine silty clay loam, pH 6.3, O.M. 2.5%
Lorraine clay loam, pH 7.9, O.M. 3.3%
Nantuna sand top soil, pH 7.4, O.M. 2.0%
Nantuna sand sub soil, pH 6.4, O.M. 1.0%

25-27.0
3.0
130.0
1.9
2.1
18.8
1.0
7.5
9.0
19.3
12.4
7.8
16.9
36.5

NR
NR
NR
16.8
10.9
243
6.8
NR
101
64.2
91.1
25.9
56.2
121

NR
NR
NR
5.1
3.3
77.1
2.0
NR
NR
13.6
19.4
5.5
NR
NR

NR
NR
NR
IORE
IORE
DFOP
IORE
SFO
FOMC
SFO
IORE
SFO
SFO
SFO

AMPA
AMPA
AMPA
AMPA
AMPA
AMPA
AMPA
AMPA
AMPA
AMPA
AMPA
AMPA
AMPA
AMPA

Proposed Re-evaluation Decision – PRVD2015-01
Page 123

Non-persistent to
moderately
persistent.
A major route of
transformation in
the environment

 Appendix X

Property

Test
Substance

AMPA

POEA
Anaerobic soil
biotransformat
ion
Foliar
dissipation

Glyphosate

Glyphosate

Material

DT50 (Days)

Lanna clay top soil, pH 7.2, O.M. 4.4%
Lanna clay subsoil, pH 7.4, O.M. 0%
Châlon silty clay, pH 8.2, O.M. 3.5%
Dijon clay soil, pH 8.2, O.M. 2.8%
Toulouse loam, pH7.6, O.M. 1.6%
Visalia sandy loam, pH 8.3, O.M. 0.6%
Kickapoo sandy loam, pH 7.3, O.M. 2.8%
Dupo silt loam, pH 7.5, O.M. 1.0%
Sandved, Denmark, pH 6.5, O.M.2.6%
Unknown
Nantuna sand top soil, pH 7.4, O.M. 2.0%
Nantuna sand sub soil, pH 6.4, O.M. 1.0%
Lanna clay top soil, pH 7.2, O.M. 4.4%
Lanna clay subsoil, pH 7.4, O.M. 0%
Châlon silty clay, pH 8.2, O.M. 3.5%
Dijon clay soil, pH 8.2, O.M. 2.8%
Toulouse loam, pH7.6, O.M. 1.6%
Ray silt loam, pH 6.5, O.M. 1.0%
Drummer silty clay, pH 7.0, O.M. 6.0%
Norfolk sandy loam, pH 5.7, O.M. 1.0%
European Water phase Soil 1
European System Soil 2
15 tested foliage values

365
501
NR
NR
NR
356.0
161.0
570.0
106
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR

Rep
t1/2
(days)
NR
NR
NR
NR
NR
107.0
48.5
263.0
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR

NR

NR

DT90
(Days)

110.0
151.0
< 1.0
0.8
3.7
107.0
48.5
2.1
32.0
151
60.4
91.3
34.9
97.6
25.0
34.0
75.0
1-14
< 7-14
< 7-14
3
1699
2.5-26.6
Average = 10.7

Proposed Re-evaluation Decision – PRVD2015-01
Page 124

Kinetic
Models
SFO
SFO
SFO
SFO
SFO
SFO
SFO
DFOP
FOMC
NR
SFO
SFO
SFO
SFO
SFO
SFO
SFO
SFO
SFO
SFO

Major
Transf.
Prod.
AMPA
AMPA
AMPA
AMPA
AMPA

Comments 1

NR

Moderately
persistent
Moderately
persistent
Non-persistent
Slightly
persistent
Moderately
persitent

NR

Non-persistent

NR

NR

Non-persistent to
persistent

NR

N/A

Non persistent

90th
NR

pcentile

14.4

 Appendix X

Property

Adsorption/
desorption

Test
Substance

Glyphosate

Material
Ray silty Loam
Drummer silty clay loam
Spinks sandy loam
Lintonia sandy loam
Cat tail swamp sediment
Houston clay loam
Muskinum silt loam
Sassafras sandy loam
Montmorilloite clay
Illite clay
Kaolinite clay
Silty clay loam
Silt loam
Loamy sand
Greenan sand
Auchincruive sandy loam
Headley sandy clay loam
Californian loamy sand
Les Evouettes II silt loam
Darnconner sediment
Unknown
Silt loam
Silty clay
Unknown
Unknown
Lilly Field sand
Visalia sandy loam
18 acres sandy loam
Wisborough Green silty clay loam
Champaign silty clay loam
Sandy muck soil
Muck soil
Sandy profile (0-1m)
Clay rich till
Sandy Achaia soil (Greece)
Ap horizon
Bs horizon
ECNR

Kd (mL/g)

Koc (mL/g)

Comments 1

73.7
56.9
70.4
16.4
164.0
Kf = 76.0
Kf = 56.0
Kf = 33.0
Kf = 138.0
Kf = 115.0
Kf = 8.0
900
34
245
263
810
50
5.3
47
510
NR
33
324
NR
NR
70
8.3
559.8
111.1
710.3
133
1188
27-385
72-1140
5.9
227.8
762
172.9

10592
2886
5059
4041
18852
4872
3415
2661
NR
NR
NR
60 000
3 800
22 300
32 830
50 660
3 598
884
3 404
17 819
2660-12930
NR
NR
500
2640
23093
1426
24771
6170
33037
NR
NR
NR
NR
NR
NR
NR
NR

Low mobility
Low mobility
Low mobility
Low mobility
Low mobility
Slight mobility
Slight mobility
Slight mobility
NR
NR
NR
Immobile
Slight mobility
Immobile
Immobile
Immobile
Slight mobility
Low mobility
Slight mobility
Immobile
Slight to immobile
NR
NR
Moderately mobile
Slightly mobile
Immobile
Low mobility
Immobile
Immobile
Immobile
Immobile
Immobile
NR
NR
NR
NR
NR
NR

Proposed Re-evaluation Decision – PRVD2015-01
Page 125

 Appendix X

Property

Test
Substance

Material
ECR
E4G
E20GSP
Nantuna sand top soil
Nantuna sand sub soil
Lanna clay top soil
Lanna clay subsoil

AMPA

POEA

SLI Soil # 1 clay loam
SLI Soil # 2 sand
SLI Soil # 4 sand
SLI Soil # 5 clay loam
SLI Soil # 9 loamy sand
SLI Soil # 11 sand
Visalia sandy loam
18 acres sandy loam
Lily filed sand
Champaign silty clay loam
Wisborough Green silty clay loam
Sandy loam
Silt loam
Clay loam
Unknown

Kd (mL/g)

Koc (mL/g)

Comments 1

251.9
152.6
193.1
124.9
Kf = 40
Kf = 28.7
Kf = 118
Kf = 165
76.0
1554.0
15.0
30.0
111.0
74.0
9.5
85.8
172.6
306.8
700.9
NR
NR
NR
NR

NR
NR
NR
NR
NR
NR
NR
NR
3640
8310
1160
3330
6920
24800
1645
4764
59510
14272
31014
2500
6000
9600
15400

NR
NR
NR
NR
NR
NR
NR
NR
Slight mobilility
Immobile
Low mobility
Slight mobilility
Immobile
Immobile
Low mobility
Slight mobility
Immobile
Immobile
Immobile
Slight mobility
Immobile
Immobile
Immobile

Proposed Re-evaluation Decision – PRVD2015-01
Page 126

 Appendix X

Property

Soil column
leaching

Test
Substance

Glyphosate

Material

Unaged soils
Lintonia sandy loam, pH 6.5, O.M. 0.7%
Ray silt, pH 8.1, O.M. 1.2%
Spinks sandy loam, pH 4.7, O.M. 2.4%
Leon sand, pH 4.8, O.M. 1.0%
Drummer silty cl loam, pH 6.2, O.M. 3.4%
Hilo sandy clay loam, pH 5.7, O.M. 9.5%
Molokai clay, pH 7.0, O.M. 3.0%
Speyer 2.1 sand, pH 6.0, O.M. 0.8%
Speyer 2.2 loamy sand, pH 6.0, O.M. 4.4%
Speyer 2.3 sandy loam, pH 6.6, O.M. 1.3%
Aged soil
Ray silt, pH 8.1, O.M. 1.2%
Molokai clay, pH 7.0, O.M.3.0%
Hilo sandy clay loam, pH 5.7, O.M.3.4%

Property

Soil TLC
(Helling
mobility
index)

Test
Substance

Glyphosate

Material
Spinks sandy loam, pH 6.1, O.M. 2%
Toledo clay loam, pH 7.4, O.M. 3.8%
Toledo clay loam, pH 7.6, O.M. 3.8%
Hillsdale sandy cl loam, pH 4.6, O.M. 1.5%
Hillsdale sandy cl loam, pH 5.6, O.M.1.3%
Hillsdale sandy cl loam, pH 6.7, O.M. 1.5%
Sandy loam topsoil, pH 6.7, 1.3% OC
Sandy loam subsoil, pH 6.7, 1.3% OC
Muck top soil (0-15 cm, pH 4.7, 30.5% OC
Muck subsoil (15-25 cm, pH 4.7, 30.5% OC
Norfolk sandy loam, pH 5, O.M.7.1%
Ray silt loam, pH 6.5, O.M. 1.0%
Drummer silty cl loam, pH 7.0, O.M.6.0%,

% recovery and detection at different depth
0-10
cm

10-20
cm

20-30
cm

> 30
cm

58.7
48.8
96.7
41.0
94.3
99.7
99.5
0
0
0

27.7
32.5
2.2
30.9
16.7
0.3
0.4
0
0
0

7.1
9.2
0.2
17.1
0.7
0
0
0
0
0

1.4
4.8
0
10.0
0.6
0
0
1.45
0.12
0.63

31.4
40.6
97.6

0.76
0.12
0.04

0.41
0.11
0.02

0.61
0.14
0

Comments 1

Max. depth
detect.
45 cm
45 cm
25 cm
65 cm
45 cm
20 cm
20 cm
40 cm
40 cm
40 cm

65 cm
60 cm
30 cm

Rf value

Mobility Index

Comments 1

0.04
0.07
0.13
0.04
0.06
0.08
0.05
0.03
0.02
0.05
< 0.09
< 0.09
< 0.09

1
1
2
1
1
1
1
1
1
1
1
1
1

Immobile
Immobile
Low mobility
Immobile
Immobile
Immobile
Immobile
Immobile
Immobile
Immobile
Immobile
Immobile
Immobile

Proposed Re-evaluation Decision – PRVD2015-01
Page 127

 Appendix X

Property

Test
Substance

Glyphosate

Leaching
potential
(Leaching
criteria of
Cohen et al.
1984)

AMPA

POEA

Property

GUS Score

Property

Criteria
Solubility > 30 mg/L
Kd < 5 and usually < 1 or 2
Koc < 300
Henry’s law constant < 10-2 atm m3/mol
pKa = Negatively charged
Hydrolysis t 1/2 > 140 d
Soil phototransformation t 1/2 > 7 d
Soil biotransformation t1/2 > 14 to 21 d
Solubility > 30 mg/L
Kd < 5 and usually < 1 or 2
Koc < 300
Henry’s law constant < 10-2 atm m3/mol
pKa = Negatively charged
Hydrolysis t 1/2 > 140 d
Soil phototransformation t 1/2 > 7 d
Soil biotransformation t1/2 > 14 to 21 d
Solubility > 30 mg/L
Kd < 5 and usually < 1 or 2
Koc < 300
Henry’s law constant < 10-2 atm m3/mol
pKa = Negatively charged
Hydrolysis t 1/2 > 140 d
Soil phototransformation t 1/2 > 7 d
Soil biotransformation t1/2 > 14 to 21 d

Criteria Met

12000 mg/L
5.3-1188 mL/g
500-58000 mL/g
2.07 × 10-14 atm m3/mole
0.8, 2.35, 5.84, 10.84
t1/2 ≤ 1627 days at pH 7
DT50: 90 d. irr. (96.3 d. dark)
DT50 = 1-19.3 days
5800 mg/L
9.5-1554 mL/g
1160-59510 mL/g
1.58 × 10-6 atm m3/mole
0.9, 5.6, 10.2
Unknown, assumed stable
DT50: 90 d. irr. (96.3 d. dark)
DT50 = 2.13-151 days
0.082 mg/L
NR
2500-15400 mL/g
2.5 × 10-13 atm m3/mole
Protonated at ambient pH
Stable at pH 7
Unknown
DT50 = 1-14 days

Yes
No
No
Yes
No
Yes
Yes
No
Yes
No
No
Yes
No
Yes
Yes
Yes
No
N/A
No
Yes
No
Yes
N/A
No

Test
Substance

GUS Score Range

Glyphosate

-1.46 to 2.46

AMPA

-1.67 to 2.03

POEA
Test
Substance

-0.22 to 0.69
Criteria
Vapour pressure (1.3 × 10-7 Pa at 20ºC)
Henry’s law constant (2.0 × 10-14 atm m3/mole)

Volatility

Value

Glyphosate

Presence of volatile in gas traps of soil lab
experiments
Soil biodegradation

Comments 1

Low potential for leaching.

Some potential for leaching.

Low potential for leaching.

Comments 1
Non-leacher to borderline
leacher.
Non-leacher to boredline
leacher.
Non-leacher.
Interpretation

Comments 1

Low
Low
Non-volatile in soil lab experiments
Non-persistent to slightly persistent
Strongly binds to soil particles

Expected to be relatively nonvolatile under field conditions.

Proposed Re-evaluation Decision – PRVD2015-01
Page 128

 Appendix X

Adsorption

Property

AMPA

Vapour pressure (8.35 = Pa (25º)
Henry’s law constant (1/H :1.55 × 104)
Microbial activity
Adsorption

POEA

Vapour pressure (6.97 × 10-12 Pa at 20ºC )
Henry’s law constant (1/H: 9.8 × 1010)
Soil biodegradation
Adsorption

Test
Substance

Material
Fredonia, New York, U.S.A., gravel loam
Casselton, North Dakota, U.S.A., clay loam
Canard, Nova Scotia, Canada
sandy loam
Canadian soil

Agricultural
Canadian
(and
Equivalent
Ecoregion)
Field Studies

Glyphosate

Manitoba, Canada
Ontario, Canada
Alberta, Canada
St-Davids, Ontario, Canada, silty clay
Carman, Manitoba, Canada, loamy sand
Grandora, Saskatchewan, Canada, clay loam
Speers, Saskatchewan, Canada, silty clay loam
Brooks, Alberta, Canada, loam
Manitoba, Canada
Ontario, Canada

Intermediate to highly
Slightly volatile from a water surface water or moist
soil
Need microbial activity to transform glyphosate into
AMPA
Strongly bind to soil particles
Low
Low
Non-persistent
Strongly bind to soil particles
Max. Soil Depth
DT50 Value (days)
Detection (cm)
0-15
Detection after 300 days

Unlikely to be volatile since it
is formed in soil and bind
strongly to soil particles.

Expected to be relatively nonvolatile under field conditions.
Comments1
Persistent

0-15

9.0

Non-persistent

0-15

16.2 (IORE)

Slightly persistent

NR

6-21

NR
NR
NR
0-30
0-15
0-12.5
0-12
0-15
NR
NR

11
16
63
NR
60
NR
87
155
128
185

Non-persistent to slightly
persistent
Non-persistent
Slightly persistent
Moderately persistent
N/A
Moderately persistent
N/A
Moderately persistent
Moderately persistent
Moderately persistent
Persistent

0-15

55.1 (DFOP)

Moderately persistent

7-12

< 60-80

Moderately persistent

0-15

45-60

Slightly to moderately
persistent

AMPA
Canard, Nova Scotia, Canada, sandy loam
Forestry
Canadian
(and
Equivalent
Ecoregion)
Field Studies

Glyphosate

Nanaimo sandy (gravelly) soil (mean station I,
II and III)
Carnation Creek, British Columbia, sandy clay
loam 0-5 cm
Carnation Creek, British Columbia, sandy clay
loam 5-15 cm
Carnation Creek, British Columbia, sandy clay
loam 15-35 cm

Proposed Re-evaluation Decision – PRVD2015-01
Page 129

 Appendix X

Carnation Creek, BC, sandy loam 0-5 cm
Carnation Creek, BC, sandy loam 5-15 cm
Carnation Creek, BC, sandy loam 15-35 cm
Harker, On, sandy soil
Lamplugh, On, clay soil
AMPA

Chassell, MI, USA

0-15
NR
Exposed soil (0-15)
Under litter (15-30)

France

24
Low recovery
NR
NR
5-197.3

Foreign
Agricultural
Field studies
(Nonequivalent
Ecoregions to
Canada)

Glyphosate

0-15
0-15
15-30
15-30
15-30
0-15
0-15
0-15
0-15
ND
ND
0-15
0-15
0-15
0-15
0-15
15-30
15-30
0-15
0-15
0-15
0-15
0-15
15-30
0-15
0-15
15-30
0-15
0-15
0-15
0-15

Proposed Re-evaluation Decision – PRVD2015-01
Page 130

N/A

1.2-24.3
36.2
27.3
35.0
43.5
34.0
55.5
17.0
4.4
17.1
95.6
1.8
15.3
12.0
1.6
68.4
174

Non persistent to persistent
Non-persistent to slightly
persistent
Slightly persistent
Slightly persistent
Slightly persistent
Slightly persistent
Slightly persistent
Moderately persistent
Slightly persistent
Non-persistent
Slightly persistent
Moderately persistent
Non-persistent
Slightly persistent
Non-persistent
Non-persistent
Moderately persistent
Moderately persistent

NR

N/A

2
16
122-174
NR

Non-persistent
Slightly persistent
Moderately persistent
NA

NR
Sweden
Holdenville, OK, USA, loam
Shawnee, OK, USA, loam
Tumbleton, AL, USA, sandy loam
Mankato, MN, USA, silty clay loam
Adel, Iowa, USA, silty clay loam
Olathe, KS, USA, silty clay loam
Clinton, IL, USA, clay loam
Joes, CO, USA, loamy sand
Twin Falls, ID, USA, silt loam
Henderson, KY, USA, silty clay loam
Perrysburg, OH, USA, clay loam
Chickasha, OK, USA, loam
Memphis, TN, USA, silty loam
Mission, TX, USA, sandy loam
Downs, CA, USA, sandy clay loam
Mankato, MN, USA, sandy clay loam
Opelika, AL, USA, sandy clay loam
Lake Alfred, FL, USA, astatula fine sand
Woolvine, VA, USA, clay loam
Grand Rapid, MI, USA, silty loam
Selah, WA, USA, sandy loam
Wapato, WA, USA, sandy loam
The Dalles, OR, USA, sandy loam
Hood River, OR, USA, sandy loam
Five points, CA, USA
Milton, WI, USA
Champaign , IL, USA
USA, Texas, sandy loam
USA, N. Carolina, sandy clay loam
USA, Minnesota, loam
USA Colorado, silt loam

Slightly persistent

 Appendix X

Texas
Ohio
Georgia
California
Arizona
Minnesota
New York
Iowa
California, USA
California, USA, sandy loam
N. Carolina, USA, sandy loam
Leland, Mississippi, USA, loam bareground
Leland, Mississippi, USA, loam turf
California, USA, sandy loam bareground
California, USA, sandy loam turf

0-15
0-15
0.15
0-15
0-15
0-15
15-30
0-15
NR
0-15
0-15
0-15
0-15
0-15
0-15

2.6
ND
ND
ND
28.7
127.8
140.6
ND
43.6
2.8
31
3.9
1.4
19
12

NR

44-60

Ohio, USA,
Georgia, USA, sandy loam
California, USA
Arizona, USA
Minnesota, USA
New York, USA
Iowa, USA, silt loam
Texas, USA

0-15
0-15
0-15
0-15
0-15
0-15
15-30
0-15

7 - 7.3
8.3 - 9
12.6 - 13
17.1
24.7 - 31
106 - 114.3
NR
1 – 1.7

Non-persistent
N/A
N/A
N/A
Slightly persistent
Moderately persistent
Moderately persistent
N/A
Slightly persistent
Non-persistent
Non-persistent
Non-persistent
Non-persistent
Slightly persistent to Nonpersistent
Slightly to moderately
persistent
Non-persistent
Non-persistent
Non-persistent
Slightly persistent
Slightly persistent
Moderately persistent
N/A
Non-persistent

Germany, 5 sites
Switzerland, 7 sites
Finland, Janakala sandy loam
Finland, Pernio clay
Michigan, USA
Georgia, USA
Oregon, USA
Germany
Switzerland

NR
NR
28
8-28
NR
NR
NR
NR
NR

12
21
90-180
< 210

Non-persistent
Slightly persistent
Moderately persistent to
persistent

35-158

Slightly to moderately
persistent

218
135-139

Persistent
Moderately persistent

Ohio, USA
Texas, USA
Arizona, USA
New York, USA
Georgia, USA

0-15
15-30
46-61
0-15
0-15

119
131
142
240
896

Moderately persistent
Moderately persistent
Moderately persistent
Moderately persistent
Persistent

California, USA

AMPA

Proposed Re-evaluation Decision – PRVD2015-01
Page 131

 Appendix X

Minnesota, USA
15-30
302
Persistent
California, USA
0-15
958
Persistent
Pacific Northwest Watershed, USA
Foliage
NR
9.5
Non-persistent
Shrubs
NR
11.6
Non-persistent
Herbs
NR
14.3
Non-persistent
Leaf litter
0-5
9.6
Non-persistent
Corvallis, OR, USA, sandy clay loam
15-30
< 14
Non-persistent
Foreign
Glyphosate
Cuthbert, GA, sandy loam
15-30
<1
Non-persistent
Forest Field
Studies (NonOregon Coast Range
—
equivalent
Foliage
10.4
Non-persistent
2-0
Ecoregions to
Litter
26.6
Slightly persistent
0-7.5
Canada)
Covered loam
29.2
Slightly persistent
0-7.5
Exposed loam
40.2
Slightly persistent
Corvallis, OR, USA, exposed soil
15-30
NR
Corvallis, OR, USA, under litter
0-15
NR
N/A
AMPA
Cuthbert, GA, USA, Exposed soil
0-15
NR
Cuthbert, GA, USA, under litter
0-15
NR
1
= Persistence classification of pesticides in soil according to Goring et al. (1975), Persistence classification of pesticides in water according to McEwen and
Stephensen (1979), Adsorption/desorption mobility class according to McCall et al. (1981), TLC mobility class according to Helling and Turner (1968),
Leaching potential based on the criteria of Cohen et al. (1984), and Ground Ubiquity Score (GUS) based on Gustafson (1989).

Proposed Re-evaluation Decision – PRVD2015-01
Page 132

 Appendix X

Table X.2

Property

Fate and Behaviour of Glyphosate, its Transformation Product AMPA and the Formulant POEA in the Aquatic
Environment

Test Substance

Glyphosate

Material
Sterile water, pH 5
Sterile water, pH 7
Sterile water, pH 9

AMPA

NR

POEA

Sterile Clam lake, water system, WI, USA, pH 4.6
Sterile Balmor Farm, water system, MO, USA, pH 7.4
Sterile Mississippi river water system, MO, USA, pH
5.7

> 30.0
1627.0
3476.0
NR

Hydrolysis

Glyphosate

DT50
(Days)

Water pH 7.5 at 22ºC

< 2128.0
< 2128.0
< 2128.0

216.0

Phototransformat
ion in Water
AMPA

Water pH 7.3

NR

Water pH 7.0

NR

Silty clay loam, pH 6.6, O.M. 0.9%
Sandy sediment, pH 7.8, O.M. 1.17%
Loamy sediment, pH 7.7, O.M. 7.24%

7.1
18.7
135.0

Glyphosate
Water compartment
Whole system

Aerobic Aquatic
Biotransformation

AMPA

1-4
27-146

Silty clay loam, pH 6.6, O.M. 0.9%

83.4

Sandy sediment system, pH 7.8, O.M. 1.17%
Loamy sediment II system, pH 7.7, O.M. 7.24%

32.0
10.0

Proposed Re-evaluation Decision – PRVD2015-01
Page 133

Rep
t1/2
Kinetic
Transf.
Comments 1
(Days
Models
Prod.
)
NR
NR
SFO
None
Stable, not a
NR
NR
SFO
None
major route of
NR
NR
SFO
None
transformation
Assumed to be stable based on the hydrolysis of the
parent glyphosate.

DT90
(Days
)

NR
NR
NR

NR
NR
NR

NR
NR
NR

NR
NR
NR

Slightly
persistent

Not a major
route of
transformation
NR
NR
SFO
AMPA
in the
environment
AMPA accumulated in irradiated samples until study
termination which would suggest that it is not subject to
phototransformation
90.8
27.3
IORE
AMPA
Non-persistent
Slightly
533
267
DFOP
AMPA
persistent
Moderately
1339
518
DFOP
AMPA
persistent
Non-persistent
N/A
N/A
N/A
Slight to
NR
N/A
N/A
N/A
moder
persistent
Moderately
277.0
83.4
SFO
CO2
persistent
72.3
21.8
IORE
Unkno
Slightly
33.1
10.0
SFO
wn
persistent

 Appendix X

Property

Test Substance

Material

Water compartment
Whole system

POEA

Anaerobic
Aquatic
Biotransformation

Glyphosate

Glyphosate

Agricultural
Aquatic Field
Dissipation
Studies
(Equivalent
Canadian
Ecoregion)

AMPA

POEA

Forestal Aquatic
Field Dissipation
Studies

Glyphosate

Clam lake, water system, WI, USA, pH 4.6
Balmor Farm, water system, MO, USA, pH 7.4
Mississippi river water system, MO, USA, pH 5.7
Missouri sandy clay loam water/sediment system, pH
7.3, O.M. 1.4%
Kentucky pond, silty clay loam water/sediment
system, pH 6.6, O.M. 0.9%
Ohio clay loam water/sediment system, pH 7.7, O.M.
3.4%
Ohio pond clay loam water/sediment system, pH 7.7,
O.M. 3.4%
Ephemeral wetland , Brandon, Canada, pH 7
Semi permanent wetland, Brandon, Canada, pH 7.9

Chassell, pond water and sediment, MI, USA

Mesocosm
Shallow water, Manitoba, Canada, pH 4.7-8.1, TOC
1.9-7.5%
Sediment, Manitoba, Canada, pH 4.7-8.1, TOC 1.97.5%
Hike pond water, Winnipeg, Canada, pH 7.7
Spruce pond water, Winnipeg, Canada, pH 8.1
Birch pond water, Winnipeg, Canada, pH 7.2

DT50
(Days)

DT90
(Days
)

Rep
t1/2
(Days
)

Kinetic
Models

Transf.
Prod.

Comments 1
Non-persistent
Non-persistent
Slightly
persistent

2-5.0
19-45.0

NR
NR

NR
NR

NR
NR

NR
NR

< 2128.0
< 2128.0
< 2128.0

NR
NR
NR

NR
NR
NR

NR
NR
NR

NR
NR
NR

Slightly
persistent

< 28.0

NR

NR

NR

AMPA

Slightly
persistent

7.0

569

273

DFOP

AMPA

Non-persistent

209.0

NR

NR

SFO

AMPA

Persistent

199.0

NR

NR

NR

AMPA

Persistent

1.3
4.8

NR
NR

NR
NR

SFO
SFO

AMPA
AMPA

7-14.0

NR

NR

SFO

NR

0.040.7
8.5-9.6

NR
NR

NR
NR

SFO
SFO

NR
NR

Non-persistent
in water
Non-persistent
in sediment

1.9
3.5
1.5

NR
NR
NR

NR
NR
NR

SFO
SFO
SFO

AMPA
AMPA
AMPA

Non-persistent
in water

Proposed Re-evaluation Decision – PRVD2015-01
Page 134

Non-persistent
in water
Non-persistent
in water
Non-persistent
in water,
declining in
sediment after
30 days but
still detected
at 335 days

 Appendix X

Property

Test Substance

Material
Manfor pond water, Winnipeg, Canada, pH 7.0
Microcosm tested water, Winnipeg, Canada
Hike pond water, Winnipeg, Canada, pH 8.1
Spruce pond water, Winnipeg, Canada, pH 8.2
Tamarack pond water, Winnipeg, Canada, pH 7.9

(Equivalent
Canadian
Ecoregion)

DT50
(Days)
2.0
5.8
3.5
10.0
11.2

DT90
(Days
)
NR
NR
NR
NR
NR

Rep
t1/2
(Days
)
NR
NR
NR
NR
NR

Kinetic
Models

Transf.
Prod.

SFO
SFO
SFO
SFO
SFO

AMPA
NR
AMPA
AMPA
AMPA

Comments 1

Non-persistent
in water
Non-persistent
in water

Flowing stream system, Chassell, MI, USA
Non-flowing pond system, Chassell, MI, USA

Stream and pond water, Chassell, MI, USA

Foreign
Agricultural
Aquatic Field
Dissipation
Studies
(Non-Equivalent
Canadian
Ecoregion)

< 7.0

NR

NR

NR

AMPA

NR

NR

NR

AMPA

≤ 0.4

AMPA

7.5

NR

NR

SFO

AMPA

Clarence sediment, MO, USA

120

NR

NR

SFO

AMPA

7-14
7-14
7-14

NR
NR
NR

NR
NR
NR

NR
NR
NR

NR
NR
NR

Non-persistent
in water

0.5
0.8

NR
NR

NR
NR

SFO
SFO

NR
NR

Non-persistent
in water

≤ 0.4< 7.0

NR

NR

SFO

AMPA

≤ 0.4< 7.0

NR

NR

SFO

AMPA

7-14

NR

NR

NR

NR

Clarence farm pond, MO, USA
Cuthbert pond, GA, USA
Ephrata irrigation ditch, WA, USA
Microcosm
Water/sediment system A, MO, USA, pH 8.3, TOC
1.5%
Water/sediment system B, MO, USA, pH 8.3, TOC
3.0%
Corvallis Stream and pond water, OR, USA

Glyphosate
Cuthbert Stream and pond water, GA, USA
AMPA
Glyphosate

Non-persistent
in water,
present in
sediment after
1 yr
Non-persistent
in water
Non-persistent
in water

Clarence water, MO, USA
Glyphosate

POEA

Foreign Forestal
Aquatic Field
Dissipation
Studies
(Non-Equivalent
Canadian
Ecoregion)
Bioaccumulation

< 7.0

Corvallis forest pond, OR, USA
Log Kow -2.8 to -0.67

Proposed Re-evaluation Decision – PRVD2015-01
Page 135

Not expected to bioaccumulate

Moderately
persistent in
sediment

Non-persistent
in water
Non-persistent
in water

 Appendix X

Property

Test Substance

DT50
(Days)

Material

DT90
(Days
)

Rep
t1/2
(Days
)

Kinetic
Models

Transf.
Prod.

Comments 1

BAF:0.03-42.3
Log Kow: -2.36to -1.61

Not expected to bioaccumulate
Due to their nature, POEA compounds (a complex mixture of as
many as 100 discrete tertiary amine molecules) may have the
potential for bioaccumulation. Log Kow and BAF were obtained from
the BCF/BAF v 3.0 model of EPIWIN v. 4 .0. However, given that
Log Kow : 2.2-5.89
POEA
BAF of 150 mL/kg
the components of these compounds are easily broken down and that
it is not persistent in soil and water, significant bioaccumulation
under field conditions is unlikely. POEA does not meet Track-1
criteria.
1
= Persistence classification of pesticides in soil according to Goring et al. (1975), Persistence classification of pesticides in water according to McEwen and
Stephensen (1979), Adsorption/desorption mobility class according to McCall et al. (1981), TLC mobility class according to Helling and Turner (1968),
Leaching potential based on the criteria of Cohen et al. (1984), and Ground Ubiquity Score (GUS) based on Gustafson (1989).
AMPA

Table X.3

Crop
Apple
Canola
Canola
Corn
Potato

Estimated Environmental Concentrations Based on Crop and Maximum Application Rates of Canadian
Registered Products Containing Glyphosate
Rate of Application
(g AMPA/ha) 1

Application
Type

4320 + 4320 + 3960
4320 + 4320 + 902
4320 + 4320 + 902
4320 + 4320 + 903 +
903
4320

Ground
Ground
Aerial

Interval
Between
Application
14
10
10

Ground

14

Ground

––

Soil DT50
(Days)
32.6
32.6
32.6
32.6

EEC Soil at 15 cm
Depth
(mg a.e./kg soil)
4.24
3.47
3.47

Refined EEC Soil at 15 cm
Depth with Drift
(mg a.e./kg soil)
0.13 (3% drift)
0.10 (3% drift)
0.59 (17% drift)

3.35

0.10 (3% drift)

1.92

0.06 (3% drift)

32.6

Proposed Re-evaluation Decision – PRVD2015-01
Page 136

 Appendix X

Table X.4

Maximum Estimated Environmental Concentrations in Vegetation and
Insects after Direct Coarse Droplet Applications of Glyphosate at Maximum
Rates on Apples (2 × 4320 g ae/ha + 1 × 3960 g ae/ha at 14-day Intervals and
a 14.4 day Foliar DT50)
Matrix

Short range grass
Long grass
Broadleaf plants
Pods with seeds
Insects
Grain and seeds
Fruit

EEC (mg a.e./kg fw) 1
1559
714
881
95
612
95
95

Fresh/Dry
Weight ratios
3.3 2
4.4 2
5.4 2
3.9 3
3.8 3
3.8 3
7.6 3

EEC (mg a.e./kg
dw)
5144.79
3141.30
4760.04
369.35
2325.38
359.88
719.76

1

Based on correlations reported in Hoerger and Kenaga (1972) and Kenaga (1973).
Fresh/dry weight ratios from Harris (1975).
3
Fresh/dry weight ratios from Spector (1956).
2

Table X.5

Refined Estimated Environmental Concentrations in Vegetation and Insects
after Direct Coarse Droplet Applications of Glyphosate at Maximum Rates
on Apples (2 × 4320 g ae/ha + 1 × 3960 g ae/ha at 14-day Intervals, 14.4 day
Foliar DT50 and 3% drift)
Matrix

Short range grass
Long grass
Broadleaf plants
Pods with seeds
Insects
Grain and seeds
Fruit

EEC (mg ai/kg fw) 1
47
21
26
3
18
3
3

Fresh/Dry Weight
Ratios
3.3 2
4.4 2
5.4 2
3.9 3
3.8 3
3.8 3
7.6 3

1

Based on correlations reported in Hoerger and Kenaga (1972) and Kenaga (1973).
Fresh/dry weight ratios from Harris (1975).
3
Fresh/dry weight ratios from Spector (1956).
2

Proposed Re-evaluation Decision – PRVD2015-01
Page 137

EEC (mg a.i./kg
dw)
154.34
94.24
142.80
11.08
69.7
10.80
21.59

 Appendix X

Table X.6

Crop

Apple
Canola
Corn
Potato

Aerobic
Rate of Application Interval
Between Water DT50
(g a.e./ha)
Application (Days)
4320 + 4320 + 3960
4320 + 4320 + 902
4320 + 4320 + 903 +
903
4320

Table X.7

Crop

Apple
Canola
Canola
Corn
Potato

The Estimated Environmental Concentration of Glyphosate in Water (mg
a.e./L) at 15 and 80 cm Depth as a Result of Direct Application from Uses on
Various Crops

14
10
14
—

413.6
413.6
413.6
413.6

Maximum
EEC in
EEC in
Cumulative
80 cm
15 cm
Application
Water
Water
Rate (g
Depth
Depth
a.e./ha)
(mg a.e./L) (mg a.e./L)
12302
8.2
1.5
9328
6.2
1.2
9934
6.6
1.2
4320

2.9

0.5

Refined Estimated Environmental Concentration of Glyphosate in Water
(mg a.e./L) at 15 and 80 cm Depth as a Result of Direct Application from
Uses on Various Crops
Refined Refined
EEC in
EEC in
EEC in
EEC in
15 cm
80 cm
Rate of Application Application
15 cm
80 cm
Water
Water
(g a.e./ha)
Type
Water
Water
Depth
Depth
Depth
Depth
(mg a.e./L) (mg a.e./L)
(mg a.e./L) (mg a.e./L)
4320 + 4320 + 3960 at Groundboom
8.20
1.54
0.25
0.05
14-day intervals
(3%)
4320 + 4320 + 902 at Groundboom
6.22
1.17
0.19
0.03
10-day intervals
(3%)
4320 + 4320 + 902 at
6.22
1.17
1.06
0.20
Aerial (17%)
10-day intervals
4320 + 4320 + 903 + Groundboom
6.62
1.24
0.20
0.04
903 at 14-day intervals
(3%)
4320
Groundboom
2.88
0.54
0.09
0.02
(3%)

Proposed Re-evaluation Decision – PRVD2015-01
Page 138

 Appendix X

Table X.8

Toxicity Values of Glyphosate Technical, Glyphosate Formulations and the
Transformation Product AMPA to Earthworms and the Collembolan

Folsomia candida
Species
Formulation
Name or
Type
Taxon
Acute Toxicity
Glyphosate Technical
Glyphosate
Technical (98.7%)
Glyphosate (N(phosphonomethyl)glycine
Earthworm
Eisenia
foetida
Glyphosate
Technical 95%

Reported
Endpoint

Degree of
Toxicity

> 1000 mg
a.e./kg soil

NR

NA

LC50

> 480 mg
a.e./kg soil

NR

NA

48-hr
LD50
7-d LC50
14-d
LC50

48-hr
LC50
Glyphosate Formulation (With POEA)
Collembola
48-hr
Folsomia
Montana® (30.8)
EC50
candida
MON 78568,
14-d
monoammonium
LD50
salt
Earthworm
Eisenia
MON 0139
foetida
28-d
(Glyphosate IPA
LC50
salt)

Roundup® FG

Comment

LC50

Technical Grade

Earthworm
Eisenia
andrei

Value

28-d
LC50

566.1 µg
a.e./cm2
345.8 mg
a.e./kg soil
327.8 mg
a.e./kg soil
> 2000 mg
a.e./kg soil

(Filter paper
test)
(Soil toxicity
test)
(Soil toxicity
test)
Highest test
concentration

1.13 mg a.e./kg
soil

Mortality

NA

NR

NA

No effect on
adult survival at
highest test
concentration.

NA

Adult survival.
No mortality at
tested rate of
application.

NA

> 4257 mg
a.e./kg soil
>28.79 mg
EUP/kg soil
>21.3 mg
a.e./kg soil
> 1.440 kg
EUP/ha
> 1.066 kg
a.e/ha
>0.47 mg
a.e/kg soil2

Proposed Re-evaluation Decision – PRVD2015-01
Page 139

Moderately
toxic1

NA

 Appendix X

Species
Formulation
Reported
Name or
Type
Endpoint
Taxon
Glyphosate Formulation (POEA Unknown)

Earthworm
Eisenia
foetida

Glyphosate (360
g/L) IPA salt

14-d
LC50

YF 11087 –
14-d
GlyphosateLC50
potassium salt
NOEC:
(513 g a.e./L)
Transformation Product AMPA
14-d
LC50
Earthworm
14-d
Eisenia
AMPA
EC50
andrei
14 –d
NOEC
Acute Avoidance
Glyphosate Technical
Earthworm
Eisenia
andrei

Glyphosate IPA

48-hr
AC50

Earthworm
Spasor® IPA salt
48-hr
Eisenia
41.5% and 165
AC50
andrei
surfactant
Reproduction
Glyphosate Formulation (With-POEA)
Collembola
28-d
Folsomia
Montana® (30.8)
EC50
candida

Montana® (30.8)

Degree of
Toxicity

> 1000 mg
a.e./kg soil

7% mortality at
highest test
concentration.

NA

> 1000 mg
a.e./kg soil
1000 mg
a.e./kg soil

NOEC based on
highest test
concentration.

NA

> 1000 mg/kg
soil
> 1000 mg/kg
soil
100 mg/kg soil

Effect on
biomass at the
highest test
concentration.

NA

No avoidance
effect at highest
test
concentration.

NA

NR

NA

>8.49 kg a.e/ha
or
>46.7 mg
a.e/kg soil
>120 mg a.e/kg
soil
>10.9 kg a.e./ha

0.54 mg a.e./kg
soil

56-d
LC50

Not determined

56-d
LC50

> 1.440 kg
EUP/ha
> 1.066 kg
a.e./ha
> 0.47 mg
a.e./kg soil2

Earthworm
Eisenia
andrei
Roundup® FG

Comment

Value

Reproduction
Significant
increase of
juveniles in
50% dilution
test (around
0.41 mg a.e./kg
soil).
Effect on
hatchability:
41% of control
at tested rate of
application.
NOEC not
reported.

Proposed Re-evaluation Decision – PRVD2015-01
Page 140

NA

NA

NA

 Appendix X

Species
Name or
Taxon

Formulation
Type

Earthworm
Eisenia
foetida

MON 0139
(Glyphosate IPA
salt)

Reported
Endpoint

Value

Comment

Degree of
Toxicity

56-d
NOEC

28.79 mg
EUP/kg soil
21.3 mg a.e./kg
soil or 30240 g
a.e./ha

No effect on
reproduction at
highest test
concentration.

NA

56-d
NOEC

28.12 mg/kg
soil

No effect on
reproduction at
high test
concentration.

NA

Transformation product AMPA
Earthworm
Eisenia
foetida

AMPA (99.1%)

1 = The 48-hr filter paper test toxicity is based on the classification of Roberts and Durough (1983).
2 = Calculated by the PMRA, where endpoint value = 1 067 000 mg a.e/ ha / ( 0.15 m [soil depth] × 100 m × 100 m × 1500 kg/ m3 [soil bulk
density]).
ND = Not detected.
NR = Not reported.
NA = Not available.
End-points in bold are to be used in risk assessment.

Table X.9

Toxicity Values of Glyphosate Technical and its Formulations to Honeybees
Reported
Endpoint

Formulation Type

Toxicity Value

Degree of
Toxicity1

Acute Oral
Glyphosate Technical
Glyphosate Technical (98.5%)

48-hr
LD50

> 100 µg/bee

Relatively
non-toxic

Glyphosate Technical (98.5%)

LD50
NOEL

> 182 µg ae/bee
182 µg ae/bee (highest
concentration tested)

Relatively
non-toxic

CP67573 Technical

LD50

> 100 µg ae/bee

Relatively
non-toxic

> 100 µg/bee

Relatively
non-toxic

Glyphosate Formulation (With POEA)
Glyphosate IPA salt, MON
LD50
2139 (36%)
MON 77360 (30% w/w
glyphosate a.e.)

LD50
NOEL

MON 78568 monoammonium
salt (65.6% a.e)

LD50
NOEL

> 30 µg ae/bee (> 100 µg
EUP/bee)
15 µg ae/bee
> 100 µg /bee
100 µg ae/bee

MON 2139 (36% a.e.)

LD50

> 100 µg a.e./bee

Proposed Re-evaluation Decision – PRVD2015-01
Page 141

Relatively
non-toxic
Relatively
non-toxic
Relatively
non-toxic

 Appendix X

Reported
Endpoint
Glyphosate Formulation (POEA Unknown)
Formulation Type

Toxicity Value

Degree of
Toxicity1

LD50
NOEL

> 86.3 µg ae/bee (> 317 µg
EUP/bee)
Relatively
86.3 µg ae/bee (317 µg EUP/bee) non-toxic
(high concentration tested)

Glyphosate Technical (97.6%)

48-hr
LD50

> 100 µg/bee

Relatively
non-toxic

Glyphosate Technical (98.5%)

LD50
NOEL

> 182 µg ae/bee
182 µg ae/bee (highest
concentration tested)

Relatively
non-toxic

CP67573 Technical

LD50

> 100 µg ae/bee

Relatively
non-toxic

> 100 µg/bee

Relatively
non-toxic

Glyphosate 360 g/L
Acute Contact
Glyphosate Technical

Glyphosate Formulation (With POEA)
Glyphosate IPA salt, MON
LD50
2139 (36%)
MON 77360 (30% w/w
glyĥosate a.e.)

LD50
NOEL

MON 78568 monoammonium
salt
(65.6% a.e)

LD50
NOEL

MON 6500 (31.32% a.e.)

48-hr
LD50
NOAEL

> 30 µg ae/bee (> 100 µg
EUP/bee)
30 µg ae/bee (highest
concentration tested)
> 76.23 µg /bee
76.23 µg ae/bee (highest
concentration tested)
> 31.3 µg ae/bee
31.3 µg ae/bee2 (highest
concentration tested)

MON 2139 (36% a.e.)

LD50

> 100 µg a.e./bee

Relatively
non-toxic

> 116 µg ae/bee (> 426 µg
EUP/bee)
116.3 µg ae/bee (426 µg
EUP/bee) (highest concentration
tested)

Relatively
non-toxic

Relatively
non-toxic
Relatively
non-toxic
Relatively
non-toxic

Glyphosate Formulation (POEA Unknown)

Glyphosate 360 g/L

LD50
NOEL

1

= Acute and oral toxicity classifcation based on Atkins et al. 1981.
This value was reported as 319 µg ae/bee, which has been deemed to be a typo. No effects were observed up to 100
µg EUP/bee, corresponding to 31.3 µg ae/bee based on the purity of 31.32%.
2

Proposed Re-evaluation Decision – PRVD2015-01
Page 142

 Appendix X

Table X.10

Toxicity Values of Glyphosate Technical and its Formulations to Beneficial
Insects

Species
Formulation
Name or
Type
Taxon
Glyphosate Technical
Western
bigeyed bug,
Geocoris
pallens

Exposure

Leaf
substrate
at rates up
to 6.7
kg/ha

Glyphosate
NOS

Glyphosate Formulation (WITH POEA)
Glass
Predatory
MON 78568,
plates
mite,
monomammon
TyphlodroLeaf
ium salt
mus pyri
substrate
Glass
plates

Reported
Endpoint

LD50

7-d LR50
7-d LR50
NOAER
48-hr
LR50
13-d LR50
NOAER:
48-hr
LR50
13-d LR50
NOAER:

Toxicity Value

Measurement
Endpoint

280 g a.e./ha (Duration and
routes of exposure are
unclear)1; dose-response
increases in survival and
also in egg viability
compared to controls

Mortality,
fecundity

1200 g a.e./ha; NOAER:
216 g a.e/ha
> 4320 g a.e./ha;
216 g a.e/ha

Mortality,
fecundity
Mortality,
fecundity

> 108 g a.e./ha
> 4320 g a.e./ha
4320 g a.e/ha

Mortality,
fecundity

> 4320 g a.e./ha
> 4320 g a.e./ha;
4320 g a.e/ha

Mortality,
fecundity

Parasitic
wasp,
Aphidius
rhopalosiphi

MON 78568,
monomammon
ium salt

Lacewing,
Chrysoperla
carnea

MON 78568,
monomammon
ium salt

Glass
plates

10-d LR50

> 4320g a.e./ha; NOAER:
4320 g a.e/ha

Mortality,
fecundity

Predatory
mite, Euseius
victoriensis

Roundup (360
g/L)

Leaf
substrate

48-h and
7-d

At 787 g a.i./ha,
2-3% mortality between 48h and 7-d;
fecundity reduced by 15.5%

Mortality and
fecundity

161.9 g a.e/ha
120 g a.e./ha (fecundity)
1567 g a.e/ha;
720 g a.e./ha

Mortality,
fecundity
Mortality,
fecundity

2267 g a.e./ha
< 598 g a.e./ha

Mortality,
fecundity

>5976 g a.e./ha
5976 g a.e./ha

Mortality,
fecundity

> 5976 g a.e./ha
5976 g a.e./ha

Mortality,
fecundity

Leaf
substrate

Glyphosate formulation (POEA UNKNOWN)
Predatory
mite,
Typhlodromus pyri

Glyphosate
360 g/L, SL
di-ammonium
salt

Parasitic
wasp,
Aphidius
rhopalosiphi

Glyphosate
360 g/L, SL
di-ammonium
salt

Hoverfly,
Episyrphus
balteatus

Glyphosate
360 g/L, SL
di-ammonium
salt

Glass
plates
Leaf
substrate
Glass
plates
Leaf
substrate
Leaf
substrate

7-d LR50
NOER
7-d LR50
NOER
48-hr
LR50
NOER
48-hr
LR50
NOER
48-hr
LR50
NOER

Proposed Re-evaluation Decision – PRVD2015-01
Page 143

 Appendix X

Species
Name or
Taxon
Lacewing,
Chrysoperla
carnea
Carabid
beetle,
Poecilus
cupreus
Staphylinid
beetle,
Aleochara
bilineata,

Formulation
Type
Glyphosate
360 g/L, diammonium
salt
Glyphosate
360 g/L, diammonium
salt
Glyphosate
360 g/L, diammonium
salt

Exposure

Reported
Endpoint

Glass
plates

48-hr
LR50
NOER

> 5976 g a.e./ha
5976 g a.e./ha

Mortality,
fecundity

Soil
substrate

7-d LR50
NOER =

> 2988 g a.e./ha
2988 g a.e./ha

Mortality,
prey
consumption

Soil
substrate

28-d
NOER

5976 g a.e./ha (highest rate
tested)

Reproduction

Toxicity Value

Measurement
Endpoint

1

The duration of exposure is not clear and the nature of the exposure appears to be a combination of contact and
oral. The results of this study are not particularly useful.

Table X.11

Toxicity Values of Glyphosate Technical and its Formulations to Birds

Species
Formulation
Name or
Type
Taxon
Acute Oral
Glyphosate Technical
Bobwhite
Glyphosate acid
quail, Colinus
(95.6%)
virginianus
Bobwhite
Glyphosate
quail, Colinus
technical (97.5%)
virginianus
Bobwhite
Glyphosate
quail, Colinus
technical
virginianus
Mallard duck,
Glyphosate
Anas
technical (97.5%)
platyrhynchos
Canary,
Serinus
canaria

Glyphosate (acid,
96.3%)

Reported
Endpoint

Toxicity Value

Degree of
Toxicity1

LD50
NOEL

> 1912 mg a.e./kg bw
1912 mg a.e./kg bw (highest
concentration tested)

Practically
non-toxic

LD50

> 2000 mg/kg bw

Practically
non-toxic

LD50

> 3196.3 mg a.e/kg bw

Practically
non-toxic

LD50
NOEL
LD50
NOAEL
ED50

> 2000 mg ae/kg bw
2000 mg a.e./kg bw (highest
concentration tested)
> 2000 mg a.e./kg bw
1200 mg a.e./kg bw
2819 mg ae/kg bw
(regurgitation)

Proposed Re-evaluation Decision – PRVD2015-01
Page 144

Practically
non-toxic
Practically
non-toxic

 Appendix X

Species
Formulation
Reported
Name or
Type
Endpoint
Taxon
Glyphosate Formulation (POEA Unknown)
Bobwhite
quail,
Colinus
virginianus

MON 58121 – no
information on
the glyphosate
content in the
formulation

Glyphosate
Bobwhite
monoammonium
quail, Colinus salt, 68.5% a.i.
virginianus
(MON 14420
formulation)
AMPA
Bobwhite
quail, Colinus AMPA, 87.8%
virginianus
Acute Dietary
Glyphosate Technical
Bobwhite
Glyphosate acid
quail, Colinus
(95.6%)
virginianus
Bobwhite
Glyphosate acid
quail, Colinus
(95.6%)
virginianus

Bobwhite
Glyphosate
quail, Colinus
(98.5%)
virginianus

Toxicity Value

Degree of
Toxicity1

LD50
NOEL
NOEL

598 mg MON 58121/kg bw3
292 mg MON 58121/kg bw
(mortality)
< 175 mg MON 58121/kg bw
(body weight and food
consumption)

Formulation
is slightly
toxic.

LD50
NOAEL

1131 mg a.e./kg bw (1651mg
formulation/kg bw)
333 mg a.e./kg bw (effect not
reported)

Formulation
is slightly
toxic.

> 1976 mg/kg bw
NOAEL: 1185 mg/kg bw

AMPA is not
toxic up to
the highest
concentraton
tested.

LD50
NOAEL

5-d LC50
NOEC =
LC50
NOAEC

LC50
NOAEC

>1743 mg a.e./kg bw/day
4860 mg a.e./kg diet (highest
concentration tested)
>5200 mg/kg diet (nominal)
(>4971.2 mg a.e./kg diet
corrected for purity);
equivalent to 5-d LD50 >528
mg a.e./kg bw/day2
4971.2 mg a.e./kg diet
>4640 mg a.e./kg diet (>4570
mg a.e./kg diet corrected for
purity); equivalent to 5-d LD50
>485 mg a.e./kg bw/day2
4570 mg a.e./kg diet (highest
concentration tested)

Proposed Re-evaluation Decision – PRVD2015-01
Page 145

Practically
non-toxic

Practically
non-toxic

Not toxic up
to highest
concentration
tested

 Appendix X

Species
Name or
Taxon

Formulation
Type

Reported
Endpoint

5-d LC50
Mallard duck,
Glyphosate acid
Anas
(95.6%)
platyrhynchos
NOEC

Toxicity Value
>5160 mg ae/kg diet based on
measured concentrations
(>4971 mg ae/kg diet based on
nominal concentrations
corrected for purity);
equivalent to a 5-d LD50 >2580
mg ae/kg bw/day
5160 mg a.e./kg diet based on
mean measured concentrations
(highest concentration tested)

Glyphosate Formulation (POEA Unknown)
MON 58121 – no
Bobwhite
information
LC50
quail, Colinus glyphosate
NOEC =
virginianus
content in the
formulation

Degree of
Toxicity1

Practically
non-toxic

>5620 mg MON 58121/kg diet3
; equivalent to >597 mg MON
Formulation
58121/kg bw/day
is practically
3160 mg MON 58121/kg diet
non-toxic
(body-weight gain)
Formulation
>1760 mg a.e./kg bw;
Glyphosate
is not toxic
Bobwhite
LC50
equivalent to LD50 >187 mg
isopropylamine
up to the
2
quail, Colinus
a.e./kg bw/day
salt, 31.32% a.i.
highest
virginianus
NOAEC 1760 mg a.e./kg bw (highest
(MON65005)
concentration
concentration tested)
tested
Formulation
>1760 mg a.e./kg bw;
Glyphosate
is not toxic
Mallard duck,
LC50
equivalent to LD50 >100 mg
isopropylamine
up to the
Anas
a.e./kg bw/day2
salt, 31.32% a.i.
highest
platyrhynchos
NOAEC 1760 mg a.e./kg bw (highest
(MON65005)
concentration
concentration tested)
tested
Glyphosate Formulation (With POEA) 21-day Dietary
45% reduced body weight at
4500 mg a.e./kg diet compared
to controls after 21-days of
expsoure.
= 450 mg a.e./kg diet (body
21-d
Chicken
Roundup
NR
weight), reported to be
NOEC
equivalent to a 21-day dietary
NOEL of approximately 43 mg
a.e./kg bw/day based on a 9.5%
consumption rate of body
weight.

Proposed Re-evaluation Decision – PRVD2015-01
Page 146

 Appendix X

Species
Formulation
Name or
Type
Taxon
AMPA
Bobwhite
quail, Colinus AMPA, 87.8%
virginianus
Mallard duck,
Anas
AMPA, 87.8%
platyrhynchos
Reproduction
Glyphosate Technical

Reported
Endpoint

LC50
NOAEC

Bobwhite
Glyphosate
quail, Colinus
technical (83%)
virginianus

NOEC

Bobwhite
Glyphosate acid
quail, Colinus
(95.6%)
virginianus

NOEC

Mallard duck,
Glyphosate (acid,
Anas
95.6%)
platyrhynchos

NOEC

Mallard duck,
Glyphosate (acid,
Anas
90.4%)
platyrhynchos

NOEC

Mallard duck,
Glyphosate
Anas
technical (83%)
platyrhynchos

NOAEC

Toxicity Value

>4934 mg/kg bw
4934 mg/kg bw

1000 mg a.e./kg diet (highest
concentration tested) (830 mg
a.e./kg diet corrected for
purity); equivalent to NOEL=
88 mg a.e./kg bw/day2
2160 mg ae/kg diet (highest
concentration tested);
equivalent to NOEL = 198 mg
ae/kg bw/day
2160 mg a.e./kg diet (highest
concentration tested);
equivalent to NOEL of 291 mg
a.e./kg bw/day
30 mg a.e./kg diet (27 mg ae/kg
diet corrected for purity)
(highest concentration tested)
equivalent to NOEL of 1.5 mg
a.e./kg bw/day2
1000 mg a.e./kg diet (830 mg
ae/kg diet corrected for purity)
(highest concentration tested)
equivalent to NOAEL = 47 mg
a.e./kg bw/day2

1

Degree of
Toxicity1

AMPA is not
toxic up to
the highest
concentration
tested

—

—

—

—

—

Oral and DietaryToxicity classification of bird; Hazard Evaluation Division, Standard Evaluation Procedure,
USEPA, 1985.
2
The toxicity endpoint was converted by the reviewer from a concentration to a daily dose using the following
general equation: Daily Dose = Concentration in food × (FIR/BW). In the absence of data from the study,
default adult body weights (178 g for bobwhite quail and 1082 g for mallard duck) and food ingestion rates
(18.9 g dry weight food/day for bobwhite quail and 61.2 g dry weight food/day for mallard duck) were used in
the calculation.
3
Content of glyphosate in the formulation is not reported. This endpoint cannot be used for risk assessment
purposes, as the daily doses used in calculations are on an active ingredient (or, in this case, acid equivalent)
basis. It is also noted that the relevance of formulation MON 58121 to Canada is not known.

Proposed Re-evaluation Decision – PRVD2015-01
Page 147

 Appendix X

Table X.12
Species Name
or Taxon

Toxicity Values of Glyphosate Technical and its Formulations to Mammals
Formulation
Type

Acute Oral
Glyphosate Technical
Glyphosate
technical (99%)
Glyphosate
technical (97.3%)
Glyphosate
technical (95.6%)
Glyphosate
technical (97.4%)
Glyphosate acid
(76 to 97.2%)
Rat
Glyphostate
isopropylamine
salt
Glyphostate
isopropylamine
salt
Glyphosate
technical
Glyphosate
technical

Reported
Endpoint

LD50

5600 mg/kg bw

LD50

> 5000 mg/kg bw

LD50

> 5000 mg/kg bw

LD50

> 5000 mg/kg bw

LD50
72 hr LD50

LD50

Rat

Practically
non-toxic
Practically
non-toxic
Practically
non-toxic
Practically
non-toxic
Practically
non-toxic
Practically
non-toxic
Practically
non-toxic

4873 mg/kg bw

Practically
non-toxic

LD50

> 5000 mg/kg bw (same
value for three different
studies)

Practically
non-toxic

1568 mg/kg bw

Slightly
toxic

> 6000 mg/kg bw
(equivalent to >4440 mg
a.e./kg bw)

Practically
non-toxic

Glyphosate
LD50
technical
Glyphostate
Deer mouse
isopropylamine
LD50
salt
Glyphosate Formulation (POEA Unknown)

MON 20033 (EZJect Capsuls),
63% a.i.
MON 77063
(Roundup
Ultradry), 65.4%
a.i.
Glyphomax,
isopropylamine

> 1920 to > 4860 mg
a.e./kg bw (8 studies)
approximately equal to
4400 mg a.e./kg bw (based
on 5957 mg a.i./kg bw)
> 5000 mg/kg bw
(equivalent to >3700 mg
a.e./kg bw)

Degree of
Toxicity1

LD50

Mouse

H-M2028, 11.4%
a.i.

Toxicity Value

LD50

LD50

357 mg a.e./kg bw
Formulation
(estimated to be equivalent
is practically
to 3132 mg formulation/kg
non-toxic.
bw)
Formulation
3150 mg a.e./kg bw (5000
is practically
mg formulation/kg bw)
non-toxic.

LD50

2599 mg a.e./kg bw (5827
mg formulation/kg bw)

Formulation
is practically
non-toxic.

LD50

724 mg a.e./kg bw (3803
mg formulation/kg bw)

Formulation
is practically

Proposed Re-evaluation Decision – PRVD2015-01
Page 148

 Appendix X

Species Name
or Taxon

Formulation
Type

Reported
Endpoint

Toxicity Value

salt, 22.9% a.i.
MON 20047,
18.4% a.i.
(Roundup
Rainfast, 25.1%
isopropylamine
salt, 18.6% a.e.)
Various
glyphosate
formulations

Degree of
Toxicity1
non-toxic.

LD50

LD50

Glyphosate Formuation (With POEA)
Roundup (360
Rat
g/L, 18%
LD50
surfactant)
Roundup (41%
Rat
a.e., 15%
72-hr LD50
surfactant)

460-690 mg a.e./kg bw
(3750 mg formulation/kg
bw)

Formulation
is practically
non-toxic.

>35.5 to >4000 mg a.e./kg
bw (41 studies)

Formulation
is not toxic
up to the
highest
concentration tested.

2300 mg formulation/kg
bw
1619 mg a.e./kg bw (5337
mg formulation/kg bw)

Rat

Roundup

LD50

>5000 mg/kg bw (unit for
exposure not specified)

Mouse

Roundup

LD50

2300 mg formulation/kg
bw (unit for exposure not
specified)

Formulation
is practically
non-toxic.
Formulation
is practically
non-toxic.
Formulation
is practically
non-toxic.
Formulation
is practically
non-toxic.

Two-generation Reproduction (Dietary Exposure)
Gyphosate Technical

Parental:
NOAEL
Glyphosate
technical (97.7%)
Rat

Offspring:
NOAEL
Repro:
NOAEL

Glyphosate
technical (99.2%)

Parental:
NOAEL
Offspring:

685/779 mg/kg bw/day
(males/females)
(decreased body weight
and body-weight gain)
115/160 mg/kg bw/day
(males/females)
(decreased body weight)
1768/2322 mg/kg bw/day
(males/females) (highest
concentration tested)
143/179 mg/kg bw/day
(males/females)
(decreased body weight
and body-weight gain)

Proposed Re-evaluation Decision – PRVD2015-01
Page 149

—

—

 Appendix X

Species Name
or Taxon

Formulation
Type

Reported
Endpoint

Toxicity Value

Degree of
Toxicity1

NOAEL
Repro:
NOAEL

Parental:
NOAEL

Glyphosate
technical (98%)

Offspring:
NOAEL
Repro:
NOAEL

NOAEL
Glyphosate
technical
(97.67%)

LOAEL

Multi-generation (Dietary Exposure)
Glyphosate Technical
NOAEL
Rat

Glyphosate acid
(98.7%)

LOAEL

Three-generation (Dietary Exposure)
Glyphosate Technical
NOAEL
Rat
Glyphosate acid
1

488/595 mg/kg bw/day
(males/females) (highest
concentration tested)
488/595 mg/kg bw/day
(males/females) (highest
concentration tested)
985/1054 mg/kg bw/day
(males/females) (highest
concentration tested)
99.4/104 mg/kg bw/day
(males/females)
(decreased body weight)
985/1054 mg/kg bw/day
(males/females) (highest
concentration tested)
500 mg/kg bw/day
(decreased body-weight
gain in F1a, F2a and F2b
male and female pups
during lactation)
1500 mg/kg bw

—

—

740 mg/kg bw/day
(decreased body weight in
parents and pups and
equivocal decrease in
average litter size)
2268 mg/kg bw/day

—

30 mg/kg bw/day (highest
concentration tested)

—

According to USEPA Hazard Classification Scheme (1985).

Proposed Re-evaluation Decision – PRVD2015-01
Page 150

 Appendix X

Table X.13 Toxicity Values of Glyphosate Technical and its Formulations to Terrestrial
Plant – Seedling Emergence
Species Name or
Taxon

Formulation
Type

Glyphosate Technical
Tomato, Solanum
Technical
lycopersicum

Study Reported
Duration Endpoint

Toxicity
Value
(kg
a.e./ha)

21-d

EC25 EC50

1.57-3.25
> 4.48> 4.48

Measurement
Endpoint

Dry weight
Survival, plant
height, dry
weight
Survival, plant
height, dry
weight

Corn, Zea mays

Technical

21-d

EC25 EC50

Oat, Avena sativa

Technical

21-d

EC25 EC50

> 4.48> 4.48

Oat, Avena sativa

CP-70139 IPA
50%

14-d

EC25 EC50
EC25 EC50

> 11.21>11.21

Emergence

2.02-4.26

Plant height

Onion, Allium cepa Technical

21-d
21-d

EC25 EC50

> 4.48> 4.48

Survival, plant
height, dry
weight

Technical

21-d

EC25 EC50

> 4.48> 4.48

Survival

Cucumber, Cucumis
Technical
sativus

21-d

EC25 EC50

> 4.48> 4.48

Sunflower,
Helianthus annuus

Technical

21-d

EC25 EC50

> 4.48> 4.48

Carrot, Daucus
carota

Technical

21-d

Wheat, Triticum
aestivum

Technical

Radish, Raphanu
sativus

Rice, Oryza sativa
Sorghum, Sorghum
bicolor
Sugar beet, Beta
vulgaris

CP-70139 IPA
50%
CP-70139 IPA
50%
CP-70139 IPA
50%

Soybean, Glycine
max

Technical

Soybean, Glycine
max
Coklebur, Xanthium
strumarium
Spiny coklebur,

CP-70139 IPA
50%
CP-70139 IPA
50%
CP-70139 IPA

14-d
14-d
14-d
21-d
14-d
14-d
14-d

EC25 EC50
EC25 EC50
EC25 EC50
EC25 EC50

2.35-4.48
> 11.21>11.21
> 11.21>11.21
> 11.21>11.21

EC25 EC50

> 4.48> 4.48

EC25 EC50
EC25 EC50
EC25 -

> 11.21>11.21
> 11.21>11.21
> 11.21-

Proposed Re-evaluation Decision – PRVD2015-01
Page 151

Survival, plant
height, dry
weight
Survival, plant
height, dry
weight
Plant height
Emergence
Emergence
Emergence
Survival, plant
height, dry
weight
Emergence
Emergence
Emergence

 Appendix X

Species Name or
Taxon

Formulation
Type

Xanthium spinosum 50%
Downy brome,
CP-70139 IPA
Bromus tectorum
50%
Proso millet,
CP-70139 IPA
Panicum miliaceum 50%
Barnyard grass,
CP-70139 IPA
Echinochloa
50%
crusgalli
Large crabgrass,
CP-70139 IPA
Digitaria
50%
sanguinalis
Wild buckwheat,
CP-70139 IPA
Polygonum
50%
convolvulus
Morning glory,
CP-70139 IPA
Ipomea spp.
50%
Hemp sesbania,
CP-70139 IPA
Sesbania exalta
50%
Common
lambsquater,
CP-70139 IPA
Chenopodium
50%
album
Pensylvania
smartweed,
CP-70139 IPA
Polygonum
50%
pensylvanicum
Velvet leaf,
CP-70139 IPA
Abutilon
50%
theophrasti
Glyphosate Formulation (Non-POEA)
Glyphosate acid,
Corn, Zea mays
wettable powder,
48.3%
Glyphosate acid,
Wheat, Triticum
wettable powder,
aestivum
48.3%
Glyphosate acid,
Wild oat, Avena
wettable powder,
fatua
48.3%
Armada Wheat,
Glyphosate acid,
Triticum aestivum
wettable powder,
cv. Armada
48.3%

EC50
EC25 EC50
EC25 EC50

Toxicity
Value
(kg
a.e./ha)
>11.21
> 11.21>11.21
>11.21>11.21

14-d

EC25 EC50

>11.21>11.21

Emergence

14-d

EC25 EC50

>11.21>11.21

Emergence

14-d

EC25 EC50

>11.21>11.21

Emergence

EC25 EC50
EC25 EC50

>11.21>11.21
>11.21>11.21

14-d

EC25 EC50

>11.21>11.21

Emergence

14-d

EC25 EC50

>11.21>11.21

Emergence

14-d

EC25 EC50

>11.21>11.21

Emergence

28-d

EC25 EC50

> 4.48> 4.48

Emergence, dry
weight

28-d

EC25 EC50

> 4.48> 4.48

Emergence, dry
weight

28-d

EC25 EC50

> 4.48> 4.48

Emergence, dry
weight

28-d

EC25 EC50

> 4.48> 4.48

Emergence, dry
weight

Study Reported
Duration Endpoint

14-d
14-d

14-d
14-d

Proposed Re-evaluation Decision – PRVD2015-01
Page 152

Measurement
Endpoint

Emergence
Emergence

Emergence
Emergence

 Appendix X

Species Name or
Taxon

Formulation
Type

Glyphosate acid,
wettable powder,
48.3%
Glyphosate acid,
Soybean, Glycine
wettable powder,
max
48.3%
Glyphosate acid,
oilseed rape,
wettable powder,
Brassica napus
48.3%
Glyphosate acid,
Goose grass,
wettable powder,
Eleusine indica
48.3%
Glyphosate acid,
Purple nutsedge,
wettable powder,
Cyperus rotundus
48.3%
Glyphosate acid,
Spiny cocklebur,
wettable powder,
Xanthium spinosum
48.3%
Glyphosate acid,
Sicklepod, Senna
wettable powder,
obtusifolia
48.3%
Sugar beet, Beta
vulgaris

Table X.14

Study Reported
Duration Endpoint

Toxicity
Value
(kg
a.e./ha)

Measurement
Endpoint

28-d

EC25 EC50

> 4.48> 4.48

Emergence, dry
weight

28-d

EC25 EC50

> 4.48> 4.48

Emergence, dry
weight

28-d

EC25 EC50

> 4.48> 4.48

Emergence, dry
weight

28-d

EC25 EC50

> 4.48> 4.48

Emergence, dry
weight

28-d

EC25 EC50

> 4.48> 4.48

Emergence, dry
weight

28-d

EC25 EC50

> 4.48> 4.48

Emergence, dry
weight

28-d

EC25 EC50

> 4.48>4.48

Emergence, dry
weight

Toxicity Values of Glyphosate Technical and its Formulations to Terrestrial
Plant – Vegetative Vigour

Species Name or
Taxon (Latin)

Formulation
Type

Study
Duration
(Day)

Endpoint
Type

Toxicity
Value (kg
a.e./ha)

Measurement
Endpoint

21

EC25

0.95

Dry weight

21

EC25

0.72

Dry weight

21

EC25

0.43

Dry weight

21

EC25

0.74

Dry weight,
survival

21

EC25

0.34

Dry weight

Glyphosate Technical
Onion, Allium cepa
Onion, Allium cepa
Oat, Avena sativa
Oat, Avena sativa
Cabbage, Brassica
oleraceae var.
capitata

Glyphosate
acid
(96.6% purity)
Glyphosate
IPA
Glyphosate
acid
(96.6% purity)
Glyphosate
IPA
Glyphosate
acid
(96.6% purity)

Proposed Re-evaluation Decision – PRVD2015-01
Page 153

 Appendix X

Species Name or
Taxon (Latin)

Formulation
Type

Glyphosate
acid
(96.6% purity)
Cucumber, Cucumis
Glyphosate
sativus
IPA
Glyphosate
Carrot, Daucus carota
IPA
Glyphosate
Soybean, Glycine max acid
(96.6% purity)
Glyphosate
Soybean, Glycine max
IPA
Sunflower,
Glyphosate
Helianthus annuus
IPA
Glyphosate
Lettuce, Lactuca
acid
sativa
(96.6% purity)
Glyphosate
Perennial rygrass,
acid
Lolium perenne
(96.6% purity)
Glyphosate
Radish, Raphanus
acid
sativus
(96.6% purity)
Radish, Raphanus
Glyphosate
sativus
IPA
Glyphosate
Tomato, Solanum
acid
lycopersicum
(96.6% purity)
Tomato, Solanum
Glyphosate
lycopersicum
IPA
Wheat, Triticum
Glyphosate
aestivum (winter)
IPA
Glyphosate
Corn, Zea mays
acid
(96.6% purity)
Glyphosate
Corn, Zea mays
IPA
Cucumber, Cucumis
sativus

Onion, Allium cepa
Onion, Allium cepa

Glyphosate
acid
(96.6% purity)
Glyphosate
IPA

Study
Duration
(Day)

Endpoint
Type

Toxicity
Value (kg
a.e./ha)

Measurement
Endpoint

21

EC25

0.46

Dry weight

21

EC25

0.51

Plant height

21

EC25

0.33

Dry weight

21

EC25

0.47

Dry weight

21

EC25

0.33

Dry weight

21

EC25

0.15

Dry weight

21

EC25

0.45

Dry weight

21

EC25

0.90

Dry weight

21

EC25

0.16

Dry weight

21

EC25

0.09

Dry weight

21

EC25

0.10

Dry weight

21

EC25

0.24

Dry weight

21

EC25

0.20

Dry weight

21

EC25

0.41

Dry weight

21

EC25

0.30

Dry weight

21

EC50

1.79

Dry weight

21

EC50

0.74

Dry weight

Proposed Re-evaluation Decision – PRVD2015-01
Page 154

 Appendix X

Species Name or
Taxon (Latin)

Formulation
Type

Glyphosate
Oat, Avena sativa
acid
(96.6% purity)
Glyphosate
Oat, Avena sativa
IPA
Cabbage, Brassica
Glyphosate
oleraceae var.
acid
capitata
(96.6% purity)
Glyphosate
Cucumber, Cucumis
acid
sativus
(96.6% purity)
Cucumber, Cucumis
Glyphosate
sativus
IPA
Glyphosate
Carrot, Daucus carota
IPA
Glyphosate
Soybean, Glycine max acid
(96.6% purity)
Glyphosate
Soybean, Glycine max
IPA
Sunflower,
Glyphosate
Helianthus annuus
IPA
Glyphosate
Lettuce, Lactuca
acid
sativa
(96.6% purity)
Glyphosate
Perennial rygrass,
acid
Lolium perenne
(96.6% purity)
Glyphosate
Radish, Raphanus
acid
sativus
(96.6% purity)
Radish, Raphanus
Glyphosate
sativus
IPA
Glyphosate
Tomato, Solanum
acid
lycopersicum
(96.6% purity)
Tomato, Solanum
Glyphosate
lycopersicum
IPA
Wheat, Triticum
Glyphosate
aestivum (winter)
IPA
Glyphosate
Corn, Zea mays
acid (96.6%
purity)

Study
Duration
(Day)

Endpoint
Type

Toxicity
Value (kg
a.e./ha)

Measurement
Endpoint

21

EC50

0.87

Dry weight

21

EC50

0.74

Dry weight,
survival

21

EC50

0.74

Dry weight

21

EC50

0.90

Dry weight

21

EC50

0.74

Dry weight,
height

21

EC50

0.65

Dry weight

21

EC50

0.97

Dry weight

21

EC50

0.66

Dry weight

21

EC50

0.30

Dry weight

21

EC50

0.76

Dry weight

21

EC50

1.34

Dry weight

21

EC50

0.25

Dry weight

21

EC50

0.25

Survival

21

EC50

0.15

Dry weight

21

EC50

0.53

Dry weight

21

EC50

0.65

Dry weight

21

EC50

0.75

Dry weight

Proposed Re-evaluation Decision – PRVD2015-01
Page 155

 Appendix X

Species Name or
Taxon (Latin)

Formulation
Type

Glyphosate
IPA
Glyphosate Formulation (Non-POEA)
Glyphosate
Okra, Abelmoshus
acid wettable
esculentus
powder, 48.3%
Onion, Allium cepa
80 WDG, 75%
Glyphosate
Oat, Avena sativa
acid wettable
powder, 48.3%
Glyphosate
Sugar beet, Beta
acid wettable
vulgaris
powder, 48.3%
Sugar beet, Beta
80 WDG, 75%
vulgaris
Glyphosate
Oilseed rape,
acid wettable
Brassica napus
powder, 48.3%
Glyphosate
Cucumber, Cucumis
acid wettable
sativus
powder, 48.3%
Cucumber, Cucumis
80 WDG, 75%
sativus
Glyphosate
Purple nutsedge,
acid wettable
Cyperus rotundus
powder, 48.3%
Glyphosate
Soybean, Glycine max acid wettable
powder, 48.3%
Soybean, Glycine max 80 WDG, 75%
Sunflower,
80 WDG, 75%
Helianthus annuus
Glyphosate
Lettuce, Lactuca
acid wettable
sativa
powder, 48.3%
Pea, Pisum sativum
80 WDG, 75%
Glyphosate
Radish, Raphanus
acid wettable
sativus
powder, 48.3%
Radish, Raphanus
80 WDG, 75%
sativus
Sorghum, Sorghum
80 WDG, 75%
bicolor
Corn, Zea mays

Study
Duration
(Day)

Endpoint
Type

Toxicity
Value (kg
a.e./ha)

Measurement
Endpoint

21

EC50

0.64

Dry weight

28

EC25

0.17

Dry weight

27

EC25

0.31

N/A

28

EC25

0.20

Dry weight

28

EC25

0.18

Dry weight

27

EC25

0.24

N/A

28

EC25

0.06

Dry weight

28

EC25

0.17

Dry weight

27

EC25

0.50

N/A

28

EC25

0.86

Dry weight

28

EC25

0.15

Dry weight

27

EC25

0.36

N/A

27

EC25

0.18

N/A

28

EC25

0.24

Dry weight

27

EC25

1.00

N/A

28

EC25

0.47

Dry weight

27

EC25

0.10

N/A

27

EC25

0.07

N/A

Proposed Re-evaluation Decision – PRVD2015-01
Page 156

 Appendix X

Formulation
Type

Study
Duration
(Day)

Endpoint
Type

Toxicity
Value (kg
a.e./ha)

Measurement
Endpoint

Wheat, Triticum
aestivum

Glyphosate
acid wettable
powder, 48.3%

28

EC25

0.13

Dry weight

Wheat, Triticum
aestivum

80 WDG, 75%

27

EC25

0.25

N/A

28

EC25

0.16

Dry weight

27

EC25

0.39

N/A

28

EC50

0.34

Dry weight

28

EC50

0.34

Dry weight

28

EC50

0.40

Dry weight

28

EC50

0.16

Dry weight

28

EC50

0.40

Dry weight

28

EC50

1.30

Dry weight

28

EC50

0.35

Dry weight

28

EC50

0.40

Dry weight

28

EC50

1.10

Dry weight

28

EC50

0.23

Dry weight

28

EC50

0.28

Dry weight

Species Name or
Taxon (Latin)

Corn, Zea mays
Corn, Zea mays

Glyphosate
acid wettable
powder, 48.3%
80 WDG, 75%

Glyphosate
acid wettable
powder, 48.3%
Glyphosate
Oat, Avena sativa
acid wettable
powder, 48.3%
Glyphosate
Sugar beet, Beta
acid wettable
vulgaris
powder, 48.3%
Glyphosate
Oilseed rape,
acid wettable
Brassica napus
powder, 48.3%
Glyphosate
Cucumber, Cucumis
acid wettable
sativus
powder, 48.3%
Glyphosate
Purple nutsedge,
acid wettable
Cyperus rotundus
powder, 48.3%
Glyphosate
Soybean, Glycine max acid wettable
powder, 48.3%
Glyphosate
Lettuce, Lactuca
acid wettable
sativa
powder, 48.3%
Glyphosate
Radish, Raphanus
acid wettable
sativus
powder, 48.3%
Glyphosate
Wheat, Triticum
acid wettable
aestivum
powder, 48.3%
Glyphosate
Corn, Zea mays
acid wettable
powder, 48.3%
Okra, Abelmoshus
esculentus

Proposed Re-evaluation Decision – PRVD2015-01
Page 157

 Appendix X

Species Name or
Taxon (Latin)

Formulation
Type

English daisy, Bellis
Roundup bio®
perennis
Cornflower,
Roundup bio®
Centaurea cyanus
Elecampane, Inula
Roundup bio®
helenium
Black-eyed Susan,
Roundup bio®
Rudbeckia hirta
Canada Goldenrod,
Roundup bio®
Solidago canadensis
Motherworth,
Roundup bio®
Leonorus cardiaca
Spearmint, Mentha
Roundup bio®
spicata
Catnip, Nepetea
Roundup bio®
cataria
Heal-all, Prunella
Roundup bio®
vulgaris
Wild buckwheat,
Polygonum
Roundup bio®
convolvulus
Curled dock, Rumex
Roundup bio®
crispus
Scarlett pimpernel,
Roundup bio®
Anagallis arvensis
Foxglove, Digitalis
Roundup bio®
purpurea
Wild mustard, Sinapis
Roundup bio®
arvensis
Common poppy,
Roundup bio®
Papaver rhoeas
Glyphosate Formulation (With POEA)
Roundup
English daisy, Bellis
original® or
perennis (NAW)
Vision®
Roundup
English daisy, Bellis
original® or
perennis (UK)
Vision®
Roundup
English daisy, Bellis
original® or
perennis (GER)
Vision®

Study
Duration
(Day)

Endpoint
Type

Toxicity
Value (kg
a.e./ha)

Measurement
Endpoint

21

EC50

0.014

Dry weight

21

EC50

0.029

Dry weight

21

EC50

0.043

Dry weight

21

EC50

0.025

Dry weight

21

EC50

0.024

Dry weight

21

EC50

0.036

Dry weight

21

EC50

0.018

Dry weight

21

EC50

0.040

Dry weight

21

EC50

0.028

Dry weight

21

EC50

0.016

Dry weight

21

EC50

0.028

Dry weight

21

EC50

0.018

Dry weight

21

EC50

0.065

Dry weight

21

EC50

0.019

Dry weight

21

EC50

0.019

Dry weight

28

EC25

0.060

Biomass
inhibition

28

EC25

0.067

Biomass
inhibition

28

EC25

0.098

Biomass
inhibition

Proposed Re-evaluation Decision – PRVD2015-01
Page 158

 Appendix X

Species Name or
Taxon (Latin)

Formulation
Type

Roundup
original® or
Vision®
Roundup
Broccoli, Brassica
original® or
oleracea var. italica
Vision®
Shepherd’s purse,
Roundup
Capsella bursaoriginal® or
pastoris
Vision®
Cornflower,
Roundup
Centaurea cyanus
original® or
(NAW)
Vision®
Cornflower,
Roundup
Centaurea cyanus
original® or
(UK)
Vision®
Cornflower,
Roundup
Centaurea cyanus
original® or
(GER)
Vision®
Mouse-eared
Roundup
chickweed, Cerastium original® or
fontanum
Vision®
Ox-eye-daisy,
Roundup
Chrysanthemum
original® or
leucanthemum
Vision®
(spring)
Ox-eye-daisy,
Roundup
Chrysanthemum
original® or
leucanthemum (fall)
Vision®
Ox-eye-daisy,
Roundup
Chrysanthemum
original® or
leucanthemum
Vision®
(winter)
Ox-eye-daisy,
Roundup
Chrysanthemum
original® or
leucanthemum
Vision®
Roundup
Foxglove, Digitalis
original® or
purpurea (NAW)
Vision®
Roundup
Foxglove, Digitalis
original® or
purpurea (NAE)
Vision®
Roundup
Foxglove, Digitalis
original® or
purpurea (GER)
Vision®
Blue grama grass,
Bouteloua gracilis

Study
Duration
(Day)

Endpoint
Type

Toxicity
Value (kg
a.e./ha)

Measurement
Endpoint

28

EC25

0.183

Biomass
inhibition

28

EC25

0.043

Biomass
inhibition

28

EC25

0.135

Biomass
inhibition

28

EC25

0.235

Biomass
inhibition

28

EC25

0.218

Biomass
inhibition

28

EC25

0.195

Biomass
inhibition

28

EC25

0.391

Biomass
inhibition

28

EC25

0.965

Biomass
inhibition

28

EC25

0.113

Biomass
inhibition

28

EC25

0.821

Biomass
inhibition

28

EC25

1.258

Biomass
inhibition

28

EC25

0.156

Biomass
inhibition

28

EC25

0.228

Biomass
inhibition

28

EC25

0.104

Biomass
inhibition

Proposed Re-evaluation Decision – PRVD2015-01
Page 159

 Appendix X

Species Name or
Taxon (Latin)
Buckwheat,
Fagopyrum
esculentum
White avens, Geum
canadense (spring)
White avens, Geum
canadense (summer)
Sunflower,
Helianthus annuus
var. “Teddybear”
Elecampane, Inula
helenium (NAW)
Elecampane, Inula
helenium (NAE)
Lettuce, Lactuca
sativa var. “Tom
Thumb” (spring)
Lettuce, Lactuca
sativa var. “Tom
Thumb” (summer)
Lettuce, Lactuca
sativa var. “Tom
Thumb” (winter)
Lettuce, Lactuca
sativa var. “Tom
Thumb”
Perennial ryegrass,
Lolium perenne
Water Hore-hound,
Lycopus americanus
(spring)
Water Hore-hound,
Lycopus americanus
(fall)
Water Hore-hound,
Lycopus americanus
(winter)

Formulation
Type
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®

Study
Duration
(Day)

Endpoint
Type

Toxicity
Value (kg
a.e./ha)

Measurement
Endpoint

28

EC25

0.196

Biomass
inhibition

28

EC25

0.450

Biomass
inhibition

28

EC25

0.042

Biomass
inhibition

28

EC25

0.061

Biomass
inhibition

28

EC25

0.761

Biomass
inhibition

28

EC25

0.100

Biomass
inhibition

28

EC25

0.007

Biomass
inhibition

28

EC25

0.003

Biomass
inhibition

28

EC25

0.404

Biomass
inhibition

28

EC25

0.790

Biomass
inhibition

28

EC25

0.206

Biomass
inhibition

28

EC25

0.141

Biomass
inhibition

28

EC25

0.087

Biomass
inhibition

28

EC25

0.058

Biomass
inhibition

Proposed Re-evaluation Decision – PRVD2015-01
Page 160

 Appendix X

Species Name or
Taxon (Latin)
Yellow sweet clover,
Melilotus officinalis
Tobacco, Nicotiana
rustica
Tioga-deer- tongue
grass, Panicum
clandestinum
Common poppy,
Papaver rhoeas
Pokeweed,
Phytolacca
americana
Pennsylvania
smartweed,
Polygonum
pensylvanicum
Heal-all, Prunella
vulgaris (NAW)
Heal-all, Prunella
vulgaris (UK)
Heal-all, Prunella
vulgaris (GER)
Black-eyed Susan,
Rudbeckia hirta
(NAW)
Black-eyed Susan,
Rudbeckia hirta
(MID)
Black-eyed Susan,
Rudbeckia hirta
(NAE)
Black-eyed Susan,
Rudbeckia hirta
(GER)
Black-eyed Susan,
Rudbeckia hirta
(spring)

Formulation
Type
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®

Study
Duration
(Day)

Endpoint
Type

Toxicity
Value (kg
a.e./ha)

Measurement
Endpoint

28

EC25

0.118

Biomass
inhibition

28

EC25

0.114

Biomass
inhibition

28

EC25

0.178

Biomass
inhibition

28

EC25

0.129

Biomass
inhibition

28

EC25

0.157

Biomass
inhibition

28

EC25

0.241

Biomass
inhibition

28

EC25

0.215

Biomass
inhibition

28

EC25

0.066

Biomass
inhibition

28

EC25

0.204

Biomass
inhibition

28

EC25

1.299

Biomass
inhibition

28

EC25

1.415

Biomass
inhibition

28

EC25

1.043

Biomass
inhibition

28

EC25

0.842

Biomass
inhibition

28

EC25

0.536

Biomass
inhibition

Proposed Re-evaluation Decision – PRVD2015-01
Page 161

 Appendix X

Species Name or
Taxon (Latin)
Black-eyed Susan,
Rudbeckia hirta (fall)
Curled dock, Rumex
crispus (NAE)
Curled dock, Rumex
crispus (PEN)
Curled dock, Rumex
crispus (UK)
Climbing nightshade,
Solanum dulcamara
Tomato, Solanum
lycopersicum var.
"Beefsteak" (summer)
Tomato, Solanum
lycopersicum var.
“Beefsteak” (winter)
Canada Goldenrod,
Solidago canadensis
(ON)
Canada Goldenrod,
Solidago canadensis
(GER)
Wheat, Triticum
aestivum (spring)
Wheat, Triticum
aestivum (winter)
Blue vervain,Verbena
hastata
Tufted vetch, Vicia
americana

Formulation
Type
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®
Roundup
original® or
Vision®

Study
Duration
(Day)

Endpoint
Type

Toxicity
Value (kg
a.e./ha)

Measurement
Endpoint

28

EC25

0.055

Biomass
inhibition

28

EC25

0.364

Biomass
inhibition

28

EC25

0.404

Biomass
inhibition

28

EC25

0.629

Biomass
inhibition

28

EC25

0.090

Biomass
inhibition

28

EC25

0.033

Biomass
inhibition

28

EC25

0.004

Biomass
inhibition

28

EC25

0.246

Biomass
inhibition

28

EC25

0.178

Biomass
inhibition

28

EC25

2.136

Biomass
inhibition

28

EC25

2.136

Biomass
inhibition

28

EC25

0.450

Biomass
inhibition

28

EC25

0.304

Biomass
inhibition

a

Ecotype: NAW = North America West; NAE = North America East; UK = United Kingdom; GER = Germany;
ON = Ontario; MID = North America Middle; PEN = Pennsylvania

Proposed Re-evaluation Decision – PRVD2015-01
Page 162

 Appendix X

Table X.15

Effects of Single Exposure to a Glyphosate Formulation (Roundup
Herbicide) on Two-Year-Old Green Ash, Fraxinus subintegerrima, Under
Field Conditions (PMRA 1883054)
NOEC
(kg a.e./ha)
0.265

LOEC
(kg a.e./ha)
>0.265

Cm of new growth

0.088

0.265

Malformed leaves

0.088

0.265

Plants damaged

0.009

0.088

< 0.009

0.009

Measurement Endpoint
Budbreak

Plants with stunted
terminals
Table X.16

EC25
(kg a.e./ha)
0.461 (Day 15)
0.070 (Day
257)
0.252 (Day
296)
0.691 (Day
367)
0.125 (Day
367)

EC50
(kg a.e./ha)
9.089 (Day 15)
0.536 (Day
257)
0.624 (Day
296)
2.115 (Day
367)
0.293 (Day
367)

0.019

0.029

Toxicity Effects of Glyphosate Technical, Glyphosate Formulations, the
Transformation Products AMPA and the Formulant POEA to Aquatic
Organisms

Species Name or
Taxon

Formulation
Type

Freshwater Invertebrate Acute Data
Glyphosate Technical
Daphnia magna
Glyphosate acid
Glyphosate
Daphnia magna
technical 98.9%
Glyphosate acid
Daphnia magna
97.3% a.e.
Daphnia magna
Glyphosate
Daphnia magna
40% glyphosate
(juvenile)
IPA
Daphnia magna
40% glyphosate
(juvenile)
IPA
Daphnia magna
40% glyphosate
(adult)
IPA
Glyphosate
Daphnia magna
technical
Glyphosate acid
Daphnia magna
83% a.e.
Daphnia magna
Glyphosate

Duration

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

24 hr

LC50

129.4

Immobilization

24 hr

EC50

123.6

Immobilization

24 hr

EC50

840

Immobilization

24 hr

EC50

234

Immobilization

48 hr

EC50

1

Immobilization

48 hr

EC50

5.3

Immobilization

48 hr

EC50

16.3

Immobilization

48 hr

EC50

84

Immobilization

48 hr

EC50

760

Immobilization

48 hr

EC50

1900

Immobilization

Proposed Re-evaluation Decision – PRVD2015-01
Page 163

 Appendix X

Species Name or
Taxon
Chironomus
plumosus
Ceriodaphnia
dubia
Ceriodaphnia
dubia
Lampsilis
siliquoidea
(larvae)
Lampsilis
siliquoidea
(Juvenile)
Lampsilis
siliquoidea
(larvae)
Lampsilis
siliquoidea
(Juvenile)
Daphnia magna
Daphnia magna

Daphnia magna

Daphnia magna

Daphnia magna

Daphnia magna

Daphnia magna

Duration

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

Glyhosate acid,
96.7%

48 hr

EC50

53.2

Mortality

Glyphosate acid

48 hr

EC50

147

Mortality

Glyphosate IPA
salt

48 hr

EC50

415

Mortality

Formulation
Type

Survival (shell
closure
response)
Mortality (based
on foot
movement)
Survival (shell
closure
response)
Mortality (based
on foot
movement)

Glyphosate
(technical grade)

48 hr

EC50

> 200

Glyphosate
(technical grade)

96 hr

EC50

> 200

Glyphosate IPA
(technical grade)

48 hr

EC50

5

Glyphosate IPA
(technical grade)

96 hr

EC50

7.2

48 hr

LC50

309

Immobilization

48 hr

LC50

377

Immobilization

48 hr

LC50

810

Immobilization

48 hr

LC50

610

Immobilization

48 hr

LC50

220

Immobilization

48 hr

LC50

365

Immobilization

48 hr

LC50

833

Immobilization

Glyphos Bio
CHA 4521
(30.9% ae)
Glyphos Bio
CHA 4525
Glyphosate IPA,
10 % with
surfactant
Geronol CF/AR
Glyphosate IPA,
35% with
surfactant
Geronol CF/AR
Glyphosate IPA,
36%, with
surfactant
Geronol CF/AR
Glyphosate IPA,
45% with
surfactant
Geronol CF/AR
Glyphosate IPA,
46%
(MON77945

Proposed Re-evaluation Decision – PRVD2015-01
Page 164

 Appendix X

Species Name or
Taxon

Daphnia magna

Daphnia magna

Daphnia magna

Daphnia magna

Daphnia magna

Daphnia magna
Daphnia
spinulata
Hyalella azteca
Chironomus
plumosus
Ceriodaphnia
dubia
Ceriodaphnia
dubia
Ceriodaphnia
dubia
Ceriodaphnia
dubia
Hyalella azteca
Hyalella azteca
Nephelopsis
obscura (leech)

Formulation
Type
Glyphosate IPA,
62.4%, no
surfactant
Glyphosate IPA
(X-77
surfactant)
Glyphosate
(80WDG
formulation),
80%
Glyphosate IPA,
35% (Roundup
Biactive),
Rhone-Poulenc
surfactant
Glyphosate,
41.2%
(Roundup –
MON 2139 NF80-AA)
RON-DO
(48% IPA)
RON-DO
(48% IPA )
Rodeo
Rodeo
(53.5% a.i.)
Rodeo
Roundup
Biactive
Roundup
Biactive
Accord
Roundup
Biactive
Rodeo
(53.5% a.i.)
Rodeo
(53.5% a.i.)

Duration

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

48 hr

LC50

401.3

Immobilization

48 hr

EC50

> 39

Immobilization

48 hr

LC50

> 17.6

Immobilization

48 hr

LC50

150

Immobilization

48 hr

LC50

94.5

Immobilization

48 hr

LC50

46

Immobilization

48 hr

LC50

49

Immobilization

48 hr

LC50

225

Mortality

48 hr

LC50

650

Mortality

48 hr

LC50

415

Mortality

48 hr

EC50

81.5

Mortality

48 hr

EC50

35.4

Mortality

48 hr

LC50

> 7.33

Mortality

96 hr

LC50

120

Mortality

96 hr

LC50

385

Mortality

96hr

LC50

630

Mortality

Proposed Re-evaluation Decision – PRVD2015-01
Page 165

 Appendix X

Species Name or
Taxon

Formulation
Type

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

48 hr

LC50

> 148

Mortality

96 hr

LC50

> 148

Mortality

96 hr

LC50

31.8

Mortality

48 hr

LC50

13

Mortality

24 hr

LC50

8.5

Immobilization

24 hr

LC50

11.6

Immobilization

48 hr

LC50

1.9

Immobilization

48 hr

LC50

7.8

Immobilization

48 hr

EC50

1.1

Immobilization

48 hr

EC50

3.2

Immobilization

48 hr

LC50

5.3

Immobilization

48 hr

EC50

2.7

Parent mortality

48 hr

LC50

2.7

Mortality

48 hr

LC50

7.8

Mortality

48 hr

LC50

22.9

Mortality

48 hr

LC50

13.3

Mortality

48 hr

LC50

5.8

Immobilization

48hr

LC50

67.8

Immobilization

Duration

Lampsilis
siliquoidea
Aqua Star®
(Larvae)
Lampsilis
siliquoidea
Aqua Star®
(Juvenile)
Glyphosate Formulation (With-POEA)
Glyphosate IPA,
Gammarus
30.3%
pseudolimnaeus
(Roundup)
Gammarus
Roundup
pseudolimnaeus
(31.0%)
Roundup®
Daphnia magna
MON 2139
Daphnia magna
Glyphosate 360
Roundup®
Daphnia magna
MON 2139
Daphnia magna
Glyphosate 360
Roundup®
Daphnia magna
(MON 2139)
Glyphosate IPA
(MON 77360),
Daphnia magna
30% a.i.
(Roundup Ultra)
Roundup
Daphnia magna
41.36%
Glyphosate IPA
Daphnia magna
(MON65005)
Roundup
Daphnia magna
(18%
glyphosate)
Roundup (18%
Daphnia magna
glyphosate)
Daphnia magna
Roundup (18%
(adult)
glyphosate)
Roundup,
Chironomus
30.3%, with
plumosus
POEA
Glyphosate IPA
Daphnia pulex
(Roundup),
30.3 %
Daphnia pulex
Roundup®
(unknown age)
MON 2139

Proposed Re-evaluation Decision – PRVD2015-01
Page 166

 Appendix X

Species Name or
Taxon

Daphnia pulex
Ceriodaphnia
dubia
Ceriodaphnia
dubia
Ceriodaphnia
dubia

Formulation
Type
Glyphosate IPA,
48% (MON
2139)
Accord SP +
POEA
Roundup
(Monsanto)
Roundup,
41% IPA salt

Duration

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

48 hr

LC50

68.3

Immobilization

48 hr

LC50

> 5.5

Mortality

48 hr

EC50

5.7

Mortality

48 hr

LC50

5.39

Mortality

Ceriodaphnia
dubia

Roundup

48 hr

LC50

7

Mortality in
porewater, 0%
TOC

Crayfish,
Orconectes nais

Roundup 30.3%

48 hr

LC50

5.2

Mortality

48 hr

LC50

1.5

Mortality

48 hr

LC50

7701.3

Mortality

48 hr

EC50

2.9

Mortality based
on Shell closure

Hyalella azteca
Crawfish,
Procambarus
cspp
Lampsilis
siliquoidea
(Larvae)
Lampsilis
siliquoidea
(Juvenile)

Roundup
(Monsanto)
Roundup
(35.6% acid
equivalent)
Roundup®

Roundup®

Glyphosate acid
Horsehair worms
and Roundup(nematode)
like formulation
Chordodes nobilii
(NOS)
POEA Alone
Daphnia pulex
MON 0818
Daphnia magna

Daphnia magna

Daphnia magna

MON 0818
POEA with
oxide:
tallowamine
ratio of 5:1
POEA with
oxide:
tallowamine
ratio of 10:1

96 hr

EC50

5.9

Mortality based
on Foot
movement

96 hr

EC50

1.76

Mortality

48 hr

EC50

2

48 hr

EC50

2.9

Mortality
Mortality based
on
immobilization

48 hr

EC50

0.176

Mortality based
on
immobilization

48 hr

EC50

0.097

Mortality based
on
immobilization

Proposed Re-evaluation Decision – PRVD2015-01
Page 167

 Appendix X

Species Name or
Taxon

Daphnia magna
C. plumosus
Ceriodaphnia
dubia
Ceriodaphnia
dubia
Fairy shrimp
(T. platyurus)

Fairy shrimp
(T. platyurus)

Fairy shrimp
(T. platyurus)

Formulation
Type

Duration

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

48 hr

EC50

0.849

Mortality based
on
immobilization

48 hr

EC50

13

Immobilization

48 hr

EC50

0.42

Mortality

48 hr

EC50

1.15

Mortality based
on animal count

48 hr

EC50

0.00517

Mortality

48 hr

EC50

0.0027

Mortality

48 hr

EC50

0.00201

Mortality

POEA with
oxide:
tallowamine
ratio of 15:1
MON 0818
Entry II ®
(POEA alone )
MON 0818
POEA with
oxide:
tallowamine
ratio of 5:1
POEA with
oxide:
tallowamine
ratio of 10:1
POEA with
oxide:
tallowamine
ratio of 15:1

Lampsilis
siliquoidea
MON 0818
(Larvae)
Lampsilis
siliquoidea
MON 0818
(Juvenile)
AMPA
Daphnia magna
AMPA
Daphnia magna
AMPA
Daphnia magna
AMPA, 94.38%
Freshwater Invertebrate Chronic Data
Glyphosate Technical
Glyphosate acid
Daphnia magna
97.6% a.e.
Glyphosate acid
Daphnia magna
97.6% a.e.
Glyphosate acid
Daphnia magna
98.7% a.e.
Glyphosate acid
Daphnia magna
99.7% a.e.
40% glyphosate
Daphnia magna
(IPA salt)

Survival (shell
closure
response)
Mortality (based
on foot
movement)

48 hr

EC50

0.5

96 hr

EC50

3.8

48 hr
48 hr
96 hr

LC50
LC50
LC50

153
651.2
683

Immobilization
Immobilization
Immobilization

21-d

EC50

101

immobilization

21-d

NOEC

51

immobilization

21-d

NOEC

29.6

Reproduction

21-d

NOEC

50

Reproduction

55-d

NOEC

1

survival

Proposed Re-evaluation Decision – PRVD2015-01
Page 168

 Appendix X

Species Name or
Taxon
Daphnia magna

Formulation
Type
40% glyphosate
(IPA salt)
Glyphosate
(Technical
grade)

Duration

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

55-d

NOEC

0.33

fecundity

21-d

EC50

> 200

Survival (shell
length)

28-d

EC50

4.8

Survival (shell
length)

21-d

NOEC

0.54

Reproduction

55-d

NOEC

0.11

fecundity

55-d

NOEC

0.33

abortion rate

28-d

EC50

3.7

Survival (shell
length)

28-d

EC50

43.8

Survival (shell
length)

28-d

EC50

1.7

Survival (shell
length)

24 hr

LC50

>84.4

Mortality

96 hr

LC50

97

Mortality

24 hr

LC50

84.9

Mortality

96 hr

LC50

124.8

Mortality

96 hr

LC50

71.4

Mortality

Lampsilis
siliquoidea
(Juvenile)
Lampsilis
Glyphosate IPA
siliquoidea
(technical grade)
(Juvenile)
Glyphosate Formulation (With POEA)
Daphnia magna
Glyphosate 360
Roundup (18%
Daphnia magna
glyphosate)
Roundup (18%
Daphnia magna
glyphosate)
Lampsilis
siliquoidea
Roundup®
(Juvenile)
Glyphosate Formulation (Non-POEA)
Lampsilis
siliquoidea
Aqua Star®
(Juvenile)
POEA Alone
Lampsilis
siliquoidea
MON0818
(Juvenile)
Freshwater Fish Acute Data
Glyphosate Technical
Fathead minnow
Glyphosate
(Pimephales
technical
promelas)
Fathead minnow
(Pimephales
Technical grade
promelas)
Fathead minnow
Glyphosate
(Pimephales
87.3%
promelas)
Rainbow trout
Glyphosate
(Oncorhynchus
(95.6%)
mykiss)
corrected
Rainbow trout
(Oncorhynchus
Glyphosate 83%
mykiss)

Proposed Re-evaluation Decision – PRVD2015-01
Page 169

 Appendix X

Species Name or
Taxon
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Carp (Cyprinus
carpio)
Carp (Cyprinus
carpio)
Carp (Cyprinus
carpio)

Duration

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

Glyphosate IPA

96 hr

LC50

> 461.8

Mortality

Glyphosate tech
96.7%

96 hr

LC50

130

Mortality

CP-67573

96 hr

LC50

38

Mortality

96 hr

LC50

95

Mortality

96 hr

LC50

171

Mortality

Glyphosate
technical

96 hr

LC50

140

Mortality

Glyphosate
technical

96 hr

LC50

240

Mortality

Glyphosate
technical

96 hr

LC50

22

Mortality

Glyphosate
technical

96 hr

LC50

10

Mortality

Glyphosate
technical

96 hr

LC50

99

Mortality

Glyphosate
technical

96 hr

LC50

93

Mortality

Glyphosate
technical

96 hr

LC50

197

Mortality

96 hr

LC50

80

Mortality

96 hr

LC50

115

Mortality

96 hr

LC50

620

Mortality

Formulation
Type

Glyphosate 360
technical (acid;
98.9%)
Glyphosate 360
technical, (acid;
98.9%)

Glyphosate
Technical grade
Glyphosate acid
97.6%
Glyphosate

Proposed Re-evaluation Decision – PRVD2015-01
Page 170

 Appendix X

Species Name or
Taxon
Harlequin Fish
(Rasbora
heteromorpha)
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)
Channel catfish
(Ictalurus
punctatus)

Duration

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

CP 67573

96 hr

LC50

168

Mortality

Glyphosate acid
(95.6% a.e.) corr

96 hr

LC50

45

Mortality

Glyphosate 360
(95.6% a.e.)

96 hr

LC50

133.3

Mortality

Glyphosate 360
(95.6% a.e.)

96 hr

LC50

200

Mortality

Glyphosate acid
(98.9% a.e).

96 hr

LC50

78

Mortality

CP 67573
(96.7%)

96 hr

LC50

>24

Mortality

Glyphosate
technical

96 hr

LC50

140

Mortality

Glyphosate
technical

96 hr

LC50

220

Mortality

Glyphosate tech
96.7%

96 hr

LC50

135

Mortality

R-50224

96 hr

LC50

2048

Mortality

R-50224

96 hr

LC50

>1000

Mortality

Glyphosate
technical (83%)

96 hr

LC50

99.6

Mortality

Glyphosate acid
(95.6%)

96 hr

LC50

44

Mortality

Technical grade

96 hr

LC50

130

Mortality

Formulation
Type

Proposed Re-evaluation Decision – PRVD2015-01
Page 171

 Appendix X

Species Name or
Taxon

Formulation
Type

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

96 hr

LC50

> 160

Mortality

96 hr

LC50

> 309

Mortality

96 hr

LC50

96.2

Mortality

96 hr

LC50

377

Mortality

96 hr

LC50

429.2

Mortality

96 hr

LC50

134

Mortality

96 hr

LC50

> 449

Mortality

96 hr

LC50

> 450

Mortality

96 hr

LC50

> 360

Mortality

96 hr

LC50

> 450

Mortality

96 hr

LC50

> 461.8

Mortality

96 hr

LC50

32.4

Mortality

96 hr

LC50

> 975

Mortality

96 hr

LC50

> 975

Mortality

96 hr

LC50

> 975

Mortality

Duration

Japanese medaka Glyphosate
(Oryzias latipes) (>99.3%)
Glyphosate Formulation (Non-POEA)
CHA4521
Rainbow trout
Glyfos BIO
(Oncorhynchus
Herbicide
mykiss)
(30.9% corr)
Rainbow trout
Rodeo® + X‐77
(Oncorhynchus
corrected
mykiss)
Rainbow trout
CHA4521
(Oncorhynchus
Glyfos BIO 450
mykiss)
(IPA 37.7%)
Rainbow trout
Rodeo® IPA
(Oncorhynchus
salt corrected
mykiss)
Rainbow trout
Rodeo/X-77
(Oncorhynchus
(surfactant)
mykiss)
40.5%
Rainbow trout
Glyphosate IPA
(Oncorhynchus
salt (46%)
mykiss)
MON77945
Rainbow trout
Glyphosate IPA
(Oncorhynchus
salt (10%) +
mykiss)
Geronol CF/AR
Rainbow trout
Glyphosate IPA
(Oncorhynchus
salt (36%) +
mykiss)
Geronol
Rainbow trout
Glyphosate IPA
(Oncorhynchus
salt (45%) +
mykiss)
Geronol
Bluegill sunfish
Glyphosate IPA
(Lepomis
(62.4% a.i)
macrochirus)
Bluegill sunfish
Glyphosate IPA
(Lepomis
(62.4% a.i)
macrochirus)
Guaru (P.
Rodeo
caudimaculatus)
Guaru (P.
Rodeo + 0,5%
caudimaculatus) Aterbane
Guaru (P.
Rodeo + 1%
caudimaculatus) Aterbane

Proposed Re-evaluation Decision – PRVD2015-01
Page 172

 Appendix X

Species Name or
Taxon

Formulation
Type

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

96 hr

LC50

1.6

Mortality

96 hr

LC50

0.16

Mortality

96 hr

LC50

6.7

Mortality

96 hr

LC50

17.3

Mortality

96 hr

LC50

5.6

Mortality

96 hr

LC50

1.2

Mortality

96 hr

LC50

1

Mortality

96 hr

LC50

1

Mortality

96 hr

LC50

2.5

Mortality

96 hr

LC50

14.4

Mortality

96 hr

LC50

13.7

Mortality

96 hr

LC50

7.6

Mortality

96 hr

LC50

1.3

Mortality

96 hr

LC50

8.3

Mortality

Duration

Glyphosate Formulation (With POEA)
Rainbow trout
(Oncorhynchus
MON 77360
mykiss)
Rainbow trout
(Oncorhynchus
MON 58121
mykiss)
Rainbow trout
Glyphosate 360
(Oncorhynchus
(36% a.e.)
mykiss)
corrected
Rainbow trout
Roundup®
(Oncorhynchus
MON 2139
mykiss)
Rainbow trout
Roundup®
(Oncorhynchus
MON 2139
mykiss)
Rainbow trout
Roundup®
(Oncorhynchus
MON 2139
mykiss)
Rainbow trout
Roundup®
(Oncorhynchus
MON 2139
mykiss)
Rainbow trout
Roundup®
(Oncorhynchus
MON 2139
mykiss)
Rainbow trout
Roundup 31%
(Oncorhynchus
a.i.
mykiss)
Rainbow trout
Roundup®
(Oncorhynchus
MON 2139
mykiss)
Rainbow trout
Roundup®
(Oncorhynchus
MON 2139
mykiss)
Rainbow trout
(Oncorhynchus
Glyphosate 41%
mykiss)
Rainbow trout
(Oncorhynchus
Glyphosate 41%
mykiss)
Rainbow trout
(Oncorhynchus
Glyphosate 41%
mykiss)

Proposed Re-evaluation Decision – PRVD2015-01
Page 173

 Appendix X

Species Name or
Taxon
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)

Duration

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

Glyphosate 41%

96 hr

LC50

14

Mortality

Glyphosate 41%

96 hr

LC50

7.5

Mortality

Glyphosate 41%

96 hr

LC50

7.4

Mortality

Glyphosate 41%

96 hr

LC50

7.6

Mortality

Glyphosate 41%

96 hr

LC50

1.6

Mortality

Glyphosate 41%

96 hr

LC50

1.4

Mortality

Glyphosate 41%

96 hr

LC50

1.4

Mortality

Glyphosate 41%

96 hr

LC50

9

Mortality

Glyphosate 41%

96 hr

LC50

7.6

Mortality

Glyphosate 41%

96 hr

LC50

7.6

Mortality

Glyphosate 41%

96 hr

LC50

7.6

Mortality

Glyphosate 41%

96 hr

LC50

3.4

Mortality

Roundup®

96 hr

LC50

5.5

Mortality

Roundup®

96 hr

LC50

8.1

Mortality

Formulation
Type

Proposed Re-evaluation Decision – PRVD2015-01
Page 174

 Appendix X

Species Name or
Taxon
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
Fry
(Oncorhynchus
mykiss)
Rainbow trout
Fry
(Oncorhynchus
mykiss)
Rainbow trout
Fry
(Oncorhynchus
mykiss)

Duration

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

Roundup®

96 hr

LC50

8.9

Mortality

Roundup®
(Vision®)

96 hr

LC50

5.5

Mortality

Roundup®
(Vision®)

96 hr

LC50

4.3

Mortality

Roundup®
(Vision®)

96 hr

LC50

10

Mortality

Roundup®
(Vision®)

96 hr

LC50

4.6

Mortality

Vision® 10%
MON 0818
surfactant

96 hr

LC50

22.9

Mortality

Vision®

96hr

LC50

10.42

Mortality

MON 2139
(Roundup) 41%

96 hr

LC50

2.5

Mortality

MON 65005

96 hr

LC50

2.5

Mortality

MON 78568

96 hr

LC50

1.9

Mortality

Roundup® 36%

96 hr

LC50

5.5

Mortality

Roundup®

96 hr

LC50

8

Mortality

Roundup® 36%

96 hr

LC50

9.24

Mortality

Formulation
Type

Proposed Re-evaluation Decision – PRVD2015-01
Page 175

 Appendix X

Species Name or
Taxon
Rainbow trout
Fry
(Oncorhynchus
mykiss)
Rainbow trout
Fry
(Oncorhynchus
mykiss)
Rainbow trout
sac Fry
(Oncorhynchus
mykiss)
Rainbow trout
swim-up Fry
(Oncorhynchus
mykiss)
Rainbow trout
fingerling
(Oncorhynchus
mykiss)
Rainbow trout
fingerling
(Oncorhynchus
mykiss)
Rainbow trout
eggs
(Oncorhynchus
mykiss)
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)

Duration

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

Roundup®

96 hr

LC50

7.8

Mortality

Roundup®

96 hr

LC50

8.5

Mortality

Roundup®
MON 2139

96 hr

LC50

2.5

Mortality

Roundup®
MON 2139

96 hr

LC50

1.2

Mortality

Roundup®
MON 2139

96 hr

LC50

0.96

Mortality

Roundup®
MON 2139

96 hr

LC50

6.1

Mortality

Roundup®
MON 2139

96 hr

LC50

11.8

Mortality

Roundup®

96 hr

LC50

4.3

Mortality

Roundup®

96 hr

LC50

1.8

Mortality

96 hr

LC50

1.8

Mortality

96 hr

LC50

3.1

Mortality

96 hr

LC50

1.8

Mortality

Formulation
Type

Roundup®
MON 2139
(36%)
Roundup®
MON 2139
(36%) pH 6.5
Roundup®
MON 2139
(36%) pH 7.5

Proposed Re-evaluation Decision – PRVD2015-01
Page 176

 Appendix X

Species Name or
Taxon
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)

Duration

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

96 hr

LC50

1.8

Mortality

96 hr

LC50

1.3

Mortality

Glyphosate 360
(36% corrected)

96 hr

LC50

4.3

Mortality

MON 2139

96 hr

LC50

1.8

Mortality

MON 2139

96 hr

LC50

1.8

Mortality

MON 2139

96 hr

LC50

1.3

Mortality

Glyphosate 41%

96 hr

LC50

5.6

Mortality

Glyphosate 41%

96 hr

LC50

7.5

Mortality

Glyphosate 41%

96 hr

LC50

4.5

Mortality

Glyphosate 41%

96 hr

LC50

4

Mortality

Glyphosate 41%

96 hr

LC50

4.2

Mortality

Glyphosate 41%

96 hr

LC50

2.4

Mortality

Glyphosate 41%

96 hr

LC50

2.4

Mortality

Glyphosate 41%

96 hr

LC50

1.8

Mortality

Formulation
Type
Roundup®
MON 2139
(36%) pH 8.5
Roundup®
MON 2139
(36%) pH 9.5

Proposed Re-evaluation Decision – PRVD2015-01
Page 177

 Appendix X

Species Name or
Taxon
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)
Bluegill sunfish
(Lepomis
macrochirus)
Fathead minnow
(P. promelas)
Fathead minnow
(P. promelas)
Channel catfish
(Ictalurus
punctatus)
Channel catfish
(Ictalurus
punctatus)
Channel catfish
(Ictalurus
punctatus)
Channel catfish
fingerlings
(Ictalurus
punctatus)
Channel catfish
sac fry (Ictalurus
punctatus)
Channel catfish
swim-up fry
(Ictalurus
punctatus)
Prochilodus
lineatus
(juvenile)
Ten spotted livebearer, C.
decemmaculatus
Ten spotted livebearer, C.
decemmaculatus

Duration

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

Roundup®
MON 2139

96 hr

LC50

8.6

Mortality

MON 77360
(Roundup Ultra)

96 hr

LC50

2.24

Mortality

MON 65005
(Roundup Pro)

96 hr

LC50

2.4

Mortality

96 hr

LC50

1.7

Mortality

96 hr

LC50

3.9

Mortality

Roundup®

96 hr

LC50

9.6

Mortality

Roundup®
MON 2139

96 hr

LC50

5.2

Mortality

Glyphosate 41%

96 hr

LC50

4.9

Mortality

Roundup®
MON 2139

96 hr

LC50

9.6

Mortality

Roundup®
MON 2139

96 hr

LC50

3.2

Mortality

Roundup®
MON 2139

96 hr

LC50

2.4

Mortality

Roundup (41%
a.i.)

96 hr

LC50

5.61

Mortality

96 hr

LC50

5.6

Mortality

96 hr

LC50

32.6

Mortality

Formulation
Type

Roundup®
MON 2139
Roundup®
41.36%
glyphosate

Panzer (48%),
IPA salt +
POEA
Credit (48%),
IPA salt +
POEA

Proposed Re-evaluation Decision – PRVD2015-01
Page 178

 Appendix X

Species Name or
Taxon
Channa
punctatus
Jenynsia
multidentata
Lee Koh
(Cyprinus carpio)
Tilapia
(Oreochromis
niloticus)
Sturgeaon,
Huso huso
Sturgeaon,
Acipenser
stellatus
Sturgeaon,
A. persicus
POEA Alone
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout
(Oncorhynchus
mykiss)
Rainbow trout fry
(Oncorhynchus
mykiss)

Duration

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

96 hr

LC50

13.34

Mortality

96 hr

LC50

14.2

Mortality

Roundup 30.5%

96 hr

LC50

3.1

Mortality

Roundup 30.5%

96 hr

LC50

3.1

Mortality

Roundup
(41% a.e./L)

96 hr

LC50

19.3

Mortality

Roundup
(41% a.e./L)

96 hr

LC50

24.7

Mortality

Roundup
(41% a.e/L)

96 hr

LC50

26.1

Mortality

MON 0818

96 hr

LC50

2

Mortality

MON 0818

96 hr

LC50

2.5

Mortality

MON 0818

96 hr

LC50

1.6

Mortality

MON 0818

96 hr

LC50

2.6

Mortality

MON 0818

96 hr

LC50

1.7

Mortality

MON 0818
pH 6.5

96 hr

LC50

7.4

Mortality

MON 0818
pH 9.5

96 hr

LC50

0.65

Mortality

MON 0818

96 hr

LC50

3.2

Mortality

Formulation
Type
Roundup flash
formulation
(41%)
Roundup Max +
POEA

Proposed Re-evaluation Decision – PRVD2015-01
Page 179

 Appendix X

Species Name or
Taxon

Formulation
Type

Fathead minnow
MON 0818
(P. promelas)
Fathead minnow
Entry® II
(P. promelas)
Channel catfish
(Ictalurus
MON 0818
punctatus)
Bluegill sunfish
(Lepomis
MON 0818
macrochirus)
Bluegill sunfish
MON 0818
(Lepomis
pH 6.5
macrochirus)
Bluegill sunfish
MON 0818
(Lepomis
pH 9.5
macrochirus)
Bluegill sunfish
(Lepomis
Entry® II
macrochirus)
AMPA
Rainbow trout
(Oncorhynchus
AMPA
mykiss)
Rainbow trout
AMPA
(Oncorhynchus
(purity 94.4%)
mykiss)
Freshwater Fish Chronic Data
Glyphosate Technical
Rainbow trout
Glyphosate
(Oncorhynchus
technical acid
mykiss)
98.9 % a.e.
Fathead minnow
(P. promelas)

Acid, technical
grade

Duration

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

96 hr

LC50

1

Mortality

96 hr

LC50

> 0.44

Mortality

96 hr

LC50

13

Mortality

96 hr

LC50

3

Mortality

96 hr

LC50

1.3

Mortality

96 hr

LC50

1

Mortality

96 hr

LC50

4.2

Mortality

48 hr

LC50

> 180

Mortality

96 hr

LC50

491

Mortality

Highest
concentration
tested
Highest
concentration
tested

21-d

NOEC

150

255-d

NOEC

25.7

NOEC

0.81

Sub-lethal
effects

NOEC

0.36

Survival

Glyphosate Formulation (With POEA)
Rainbow trout
(Oncorhynchus
Glyphosate 360
21-d
mykiss)
Glyphosate 360
Galaxias
(360 mg a.i./L,
26-d
anomalus
10 – 20%
POEA)

Proposed Re-evaluation Decision – PRVD2015-01
Page 180

 Appendix X

Species Name or
Taxon

Formulation
Type

Fresh Water Algae Acute Data
Glyphosate Technical
Glyphosate acid
S. capricornutum
95.6% a.e.
Glyphosate acid
S. capricornutum
95.6% a.e.
Glyphosate acid,
S. capricornutum
95% (corrected)
Glyphosate acid
S. capricornutum
96.6% a.e.
Glyphosate IPA
S. capricornutum
acid
Glyphosate IPA
S. capricornutum
salt
Glyphosate acid
S. capricornutum
95.6% a.e.
Glyphosate acid
A. flos-aquae
95.6% a.e.
Glyphosate acid
A. flos-aquae
95.6% a.e.
Glyphosate acid
A. flos-aquae
95.6% a.e.
Glyphosate
technical
A. flos-aquae
(96.6%)
corrected
Glyphosate acid
N. pelliculosa
95.6% a.e.
Glyphosate acid
N. pelliculosa
96.6% a.e.
Freshwater
Glyphosate IPA
periphyton in
(corrected)
shade
Freshwater
Glyphosate IPA
periphyton in
(corrected)
shade
Glyphosate acid,
C. vulgaris
95%
Glyphosate acid,
C. vulgaris
97.5%
Glyphosate acid,
C. saccharophila
97.5%
S. subspicatus
Glyphosate acid

Duration

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

120 hr

EC50

13

Cell density

120 hr

EC50

16

Biomass

48 hr

EC50

256.5

Growth

7-d

EC50

13.8

Growth

96 hr

EC50

24.7

Growth

96 hr

EC50

41

Growth

120 hr

EC50

21

Growth

120 hr

EC50

18

Cell density

120 hr

EC50

15

Biomass

120 hr

EC50

38

Growth

7-d

LC50

4.3

Growth

120 hr

EC50

17

Biomass

7-d

EC50

24.9

inhibition

6 hr

EC50

8.7

photosynthetic
efficicency

6 hr

EC50

26.3

photosynthetic
efficicency

96 hr

EC50

4.7

Growth

72 hr

EC50

41.7

Growth

72 hr

EC50

40.6

Growth

72 hr

EC50

26

Growth

Proposed Re-evaluation Decision – PRVD2015-01
Page 181

 Appendix X

Species Name or
Taxon

Formulation
Type

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

72 hr

EC50

326.9

Growth

96 hr

EC50

3.53

Growth

96 hr

EC50

590

Growth

96 hr

EC50

68

Growth

96 hr

EC50

88

Growth

96 hr

EC50

55.85

Growth

96 hr

EC50

10.2

Growth

96 hr

EC50

24.5

Growth

96 hr

EC50

7.2

Growth

24 hr

EC50

280

Growth

72 hr

EbC50

51

Biomass

72 hr

ErC50

100.2

Growth rate

72 hr

EbC50

58.4

Biomass

72 hr

ErC50

77.9

Growth

72 hr

EbC50

24.1

Biomass

72 hr

ErC50

42.6

Growth

Duration

97.5%
Glyphosate acid
S. subspicatus
98.8% a.i.
Glyphosate
C. pyrenoidosa
(technical 95%)
Glyphosate acid,
C. pyrenoidosa
96.7%
Glyphosate acid,
C. hypnosporum
96.7%
Glyphosate acid,
Z. clindricum
96.7%
Glyphosate acid,
S. obliquus
95%
Glyphosate IPA,
S. acutus
99.5%
Glyphosate acid,
S. acutus
97.5%
Glyphosate IPA
S. quadricauda
salt (99.5%)
C. fusa
Glyphosate IPA
Glyphosate Formulation (Non-POEA)
CHA 4520
Glyphos Bio
S. capricornutum
(31.3%
corrected)
CHA 4520
Glyphos Bio
S. capricornutum
(31.3%
corrected)
CHA 4521
Glyphos Bio
S. capricornutum
(30.9%
corrected)
CHA 4521
Glyphos Bio
S. capricornutum
(30.9%
corrected)
CHA 45EXT
S. capricornutum (31.3%
corrected)
CHA 45EXT
S. capricornutum (31.3%
corrected)

Proposed Re-evaluation Decision – PRVD2015-01
Page 182

 Appendix X

Glyphosate IPA
salt, 36% +
S. capricornutum
Geronol CF/AR
S. capricornutum CHA 4525
Glyphos Bio
S. capricornutum
450 (37.7%)
Ankistrodesmus
Rodeo (no
sp.
surfactant)
N. pelliculosa
Glyfos B 31%
Glyphosate Formulation (With POEA)
Roundup, 360
S. capricornutum
g/L
Glyphosate 360
S. capricornutum
g/L
Glyphosate 360
S. capricornutum
g/L
Glyphosate 360
S. capricornutum
g/L
S. capricornutum MON 78568,
Roundup, 41%
S. capricornutum
IPA salt
Glyphos IPA
S. capricornutum
(31%)
Ron-do, 48%
S. quadricauda
IPA
ATANOR (48%
glyphosate IPA;
Chlorella kessleri
surfactant: 50%
IMPACTO
POEA Alone

72 hr

EC50

Toxicity
Value
(mg
a.e./L)*
97

72 hr

EC50

39

NR

96 hr

EbC50

24.8

biomass

96 hr

ErC50

130.1

growth

96 hr

EC50

29

NR

96 hr

EC50

0.12

NR

48 hr

EC50

19

Growth

72 hr

EC50

34

Cell density

72 hr

EC50

38

Biomass

72 hr

EC50

87

Growth

72 hr

EC50

11.2

96 hr

IC50

5.81

NR
Growth
inhibition

96 hr

LC50

0.68

NR

96 hr

LC50

9.09

NR

96 hr

EC50

19.7

Growth

S. capricornutum

POEA

96 hr

IC50

3.92

S. capricornutum
N. pelliculosa
AMPA
Scenedesmus
subspicatus
Scenedesmus
subspicatus
Scenedesmus
subspicatus

POEA
POEA

96 hr
96 hr

EC50
EC50

4.1
3.35

Growth
inhibition
NR
NR

AMPA

120 hr

EC50

74

Cell density

AMPA

120 hr

EC50

89.8

Biomass

AMPA

120 hr

EC50

440

Growth

Species Name or
Taxon

Formulation
Type

S. capricornutum

Duration

Reported
Endpoint

Proposed Re-evaluation Decision – PRVD2015-01
Page 183

Measurement
Endpoint
NR

 Appendix X

Species Name or
Taxon

Formulation
Type

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

21-d

EC50

292.3

Growth

21-d

EC50

>169

Growth

21-d

EC50

>169

Growth

21-d

EC50

598.4

Growth

21-d

EC50

256.5

Growth

21-d

EC50

164.9

Growth

21-d

EC50

251.4

Growth

21-d

EC50

246.6

Growth

21-d

EC50

27.1

Growth

21-d

EC50

7.6

Growth

21-d

EC50

6.5

Growth

21-d

EC50

9.7

Growth

21-d

EC50

0.7

Growth

21-d

EC50

20.7

Growth

21-d

EC50

1.5

Growth

21-d

EC50

0.9

Growth

10-d

EC50

20.5

NR

14-d

EC50

12

Fronds

Duration

Freshwater Algae Chronic Data
Glyphosate Technical
Chlorella
Glyphosate
vulgaris
Spirulina
Glyphosate
plastensis
Arthrospira
Glyphosate
fusiformis
Nostoc
Glyphosate
punctiforme
Anabaena
Glyphosate
catenula
Synechocystis
Glyphosate
aquatilis
Microcystis
Glyphosate
eruginosa
Leptolynbya
Glyphosate
boryana
Glyphosate Formulation (With POEA)
Chlorella
Roundup 360
vulgaris
SL (23%)
Spirulina
Roundup 360
plastensis
SL (23%)
Arthrospira
Roundup 360
fusiformis
SL (23%)
Nostoc
Roundup 360
punctiforme
SL (23%)
Anabaena
Roundup 360
catenula
SL (23%)
Synechocystis
Roundup 360
aquatilis
SL (23%)
Microcystis
Roundup 360
eruginosa
SL (23%)
Leptolynbya
Roundup 360
boryana
SL (23%)
Freshwater Plants Acute Data
Glyphosate Technical
Glyphosate acid,
L. gibba
95%
Glyphosate acid
L. gibba
95.6% a.e.

Reported
Endpoint

Proposed Re-evaluation Decision – PRVD2015-01
Page 184

 Appendix X

Species Name or
Taxon

Formulation
Type

L. Minor
Pontederia
cordata

MON 2139

MON 78087
(31.2%)
MON 78087
Carex comosa
(31.2%)
MON 78087
Nymphea odorata
(31.2%)
Amphibians Acute Data
Glyphosate Technical
Crinia insignifera Glyphosate acid
Glyphosate acid,
Crinia insignifera
96%
Glyphosate IPA
Crinia insignifera
salt
Glyphosate acid,
Crinia insignifera
96%
Glyphosate IPA
Heleioporus eyrei
salt
Limnodynastes
Glyphosate IPA
dorsalis
salt

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

14-d

EC50

16

Dry wt

14-d

EC50

30.7

Growth

14-d

EC50

31.9

Biomass

7-d

EC50

23.2

Biomass

7-d

EC50

46.9

NR

7-d

EC50

31

NR

7-d

EC50

7.7

NR

10-d

EC50

11.6

Growth

48 hr

EC50

> 16.91

NR

7-d

EC50

3.36

Growth

14-d

EC50

2

7-d

ErC50

> 1.824

21-d

EC50

0.0488

21-d

EC50

0.0625

Growth
Growth
inhibition
Fresh shoot
biomass
Fresh shoot
biomass

21-d

EC50

0.0475

Fresh biomass

48 hr

LC50

83.6

Mortality

96 hr

LC50

75

Mortality

48 hr

LC50

> 466

Mortality

96 hr

LC50

103.2

Mortality

48 hr

LC50

> 373

Mortality

48 hr

LC50

> 400

Mortality

Duration

Glyphosate acid
95.6% a.e.
Glyphosate acid
L. gibba
95.6% a.e.
Glyphosate acid
L. gibba
95.6% a.e.
Glyphosate acid,
L. gibba
96.8%
Glyphosate acid,
L. Minor
95%
L. paucicostata
Glyphosate, IPA
Glyphosate Formulation (Non-POEA)
Glyphos
L. gibba
(Glyphosate IPA
salt, 31%)
Glyphosate Formulation (With POEA)
Roundup Max,
L. gibba
70.7% a.e.
L. Minor
Roundup
Roundup
L. Minor
360 g/L
L. Minor
Roundup
L. gibba

Reported
Endpoint

Proposed Re-evaluation Decision – PRVD2015-01
Page 185

 Appendix X

Species Name or
Taxon

Formulation
Type

48 hr
48 hr
48 hr

LC50
LC50
LC50

Toxicity
Value
(mg
a.e./L)*
81.2
121
> 343

96 hr

LC50

> 17.9

Mortality

48 hr

LC50

328

Mortality

48 hr

LC50

> 400

Mortality

48 hr

LC50

> 427

Mortality

48 hr

LC50

> 494

Mortality

96 hr

LC50

> 450

Mortality

96 hr

LC50

> 100

Mortality

96 hr

LC50

> 360

Mortality

96 hr

LC50

> 360

Mortality

96 hr

LC50

> 17.9

Mortality

96 hr

LC50

7297

Mortality

96 hr

LC50

2.8

Mortality

96 hr

LC50

3.2

Mortality

96 hr

LC50

2.8

Mortality

96 hr

LC50

<4

Mortality

96 hr

LC50

4.8

Mortality

Duration

Litoria moorei
Glyphosate acid
Litoria moorei
Glyphosate acid
Litoria moorei
Glyphosate IPA
Lithobates
Glyphosate IPA
clamitans
salt
Glyphosate Formulation (Non-POEA)
Roundup
Litoria moorei
Biactive® MON
77920
Roundup
Limnodynastes
Biactive® MON
dorsalis
77920
Roundup
Heleioporus eyrei Biactive® MON
77920
Roundup
Crinia insignifera Biactive® MON
77920
Ranidella
Glyphosate IPA
signifera
45% + Geronol
Ranidella
Glyphosate IPA
signifera
10% + Geronol
Ranidella
Glyphosate IPA
signifera
36% + Geronol
Ranidella
Roundup
signifera
Biactive® 36%
Roundup
Lithobates
Biactive® MON
clamitans
77920
Xenopus laevis
Rodeo®
Glyphosate Formulation (With POEA)
Ambystoma
Roundup
gracile
Original® Max
Ambystoma
Roundup
laterale
Original® Max
Ambystoma
Roundup
maculatum
Original® Max
Roundup
Anaxyrus
Original®/MON
americanus
78087 (15%
POEA)
Anaxyrus
Vision® (15%
americanus
POEA) pH 6

Reported
Endpoint

Proposed Re-evaluation Decision – PRVD2015-01
Page 186

Measurement
Endpoint
Mortality
Mortality
Mortality

 Appendix X

Species Name or
Taxon
Anaxyrus
americanus
Anaxyrus
americanus
Anaxyrus
americanus
Anaxyrus
americanus
Anaxyrus
americanus
Anaxyrus boreas
Anaxyrus fowleri
Centrolene
prosoblepon
Crinia insignifera
Crinia insignifera
Crinia insignifera
Crinia insignifera

Formulation
Type
Vision® (15%
POEA) pH 7.5
Roundup
Original®/MON
78087 (15%
POEA)
Roundup
Original® Max
Vision® (15%
POEA) pH 7.5
Vision® (15%
POEA) pH 6
Roundup
Original® Max
Roundup
Weathermax
Glyphos
+ Cosmo‐Flux
(10-15% POEA)
Roundup® 360
Roundup®
(MON 2139)
Roundup®
(MON 2139)
Roundup® 360

Crinia insignifera Roundup® 360
Roundup®
Crinia insignifera
(MON 2139)
Glyphos
Dendropsophus
+ Cosmo‐Flux
microcephalus
(10-15% POEA)
Glyphos
Engystomops
+ Cosmo‐Flux
pustulosus
(10-15% POEA)
Roundup®
Heleioporus eyrei
(MON 2139)
Roundup®
Heleioporus eyrei
(MON 2139)
Roundup
Hyla chrysocelis
Weathermax
Hyla chrysocelis Roundup®

Duration

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

96 hr

LC50

6.4

Mortality

96 hr

LC50

8

Mortality

96 hr

LC50

1.6

Mortality

96 hr

LC50

1.7

Mortality

96 hr

LC50

2.9

Mortality

96 hr

LC50

2

Mortality

96 hr

LC50

1.96

Mortality

96 hr

LC50

2.4

Mortality

48 hr

LC50

30.4

Mortality

48 hr

LC50

49.4

Mortality

48 hr

LC50

51.8

Mortality

96 hr

LC50

5.6

Mortality

48 hr

LC50

38.2

Mortality

48 hr

LC50

3.6

Mortality

96 hr

LC50

1.2

Mortality

96 hr

LC50

2.8

Mortality

48 hr

LC50

6.3

Mortality

48 hr

LC50

8.6

Mortality

96 hr

LC50

3.26

Mortality

2.5

Mortality

96 hr

Proposed Re-evaluation Decision – PRVD2015-01
Page 187

 Appendix X

Species Name or
Taxon

Hyla versicolor
Hypsiboas
crepitans
Limnodynastes
dorsalis
Litoria moorei
Litoria moorei
Notophthalmus
viridescens
Pseudacris
crucifer
Lithobates
clamitans
Lithobates
clamitans
Rana cascadae
Lithobates
catesbeianus
Lithobates
catesbeianus
Lithobates
catesbeianus
Lithobates
clamitans
Lithobates
clamitans
Lithobates
clamitans
Lithobates
clamitans
Lithobates
clamitans

Formulation
Type
original
formulation
Roundup
Original® Max
Glyphos
+ Cosmo‐Flux
(10-15% POEA)
Roundup®
(MON 2139)
Roundup®
(MON 2139)
Roundup®
(MON 2139)
Roundup
Original® Max
Roundup
Original® Max
Vision® (15%
POEA)
Vision® (15%
POEA)
Roundup
Original® Max
Roundup
Original® Max
Roundup
Weathermax
Roundup®
original
formulation
Glyfos BIO®
with 3-7%
POEA
Glyfos AU®
with 3-7%
POEA
Roundup®
original
formulation
Vision® (15%
POEA) pH 7.5
Roundup
Transorb®

Duration

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

LC50
96 hr

LC50

1.7

Mortality

96 hr

LC50

2.1

Mortality

48 hr

LC50

3

Mortality

48 hr

LC50

2.9

Mortality

48 hr

LC50

11.6

Mortality

96 hr

LC50

2.7

Mortality

96 hr

LC50

0.8

Mortality

96 hr

LC50

2.7

Mortality

96 hr

LC50

4.34

Mortality

96 hr

LC50

1.7

Mortality

96 hr

LC50

0.8

Mortality

96 hr

LC50

1.97

Mortality

96 hr

LC50

2.77

Mortality

96 hr

LC50

> 17.9

Mortality

96 hr

LC50

8.9

Mortality

96 hr

LC50

4.22

Mortality

96 hr

LC50

1.4

Mortality

96 hr

LC50

2.2

Mortality

Proposed Re-evaluation Decision – PRVD2015-01
Page 188

 Appendix X

Species Name or
Taxon

Lithobates
clamitans
Lithobates
clamitans
Lithobates
clamitans
Lithobates
clamitans
Lithobates
clamitans
Lithobates
clamitans

Lithobates
clamitans
Lithobates
pipiens
Lithobates
pipiens
Lithobates
pipiens
Lithobates
pipiens
Lithobates
pipiens
Lithobates
pipiens
Lithobates
pipiens
Lithobates
pipiens
Lithobates
pipiens
Lithobates
pipiens

Formulation
Type
(15% POEA)
Roundup
Weathermax
Vision® (15%
POEA) pH 6
Vision® (15%
POEA) pH 7.5
Vision® (15%
POEA) pH 6
Roundup
Original® Max
Roundup
Original®/MON
78087 (15%
POEA)
Roundup
Original®/MON
78087 (15%
POEA)
Roundup
Weathermax
Roundup
Original® Max
Roundup
Original®/MON
78087 (15%
POEA)
Vision® (15%
POEA)
Vision® (15%
POEA)
Roundup
Original®/MON
78087 (15%
POEA)
Vision® (15%
POEA) pH 6
Vision® (15%
POEA) pH 7.5
Vision® (15%
POEA) pH 7.5
Vision® (15%
POEA) pH 6

Duration

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

96 hr

LC50

2.77

Mortality

96 hr

LC50

3.5

Mortality

96 hr

LC50

4.1

Mortality

96 hr

LC50

5.3

Mortality

96 hr

LC50

1.4

Mortality

96 hr

LC50

7.1

Mortality

96 hr

LC50

2

Mortality

96 hr

LC50

2.27

Mortality

96 hr

LC50

1.5

Mortality

96 hr

LC50

2.9

Mortality

96 hr

LC50

4.25

Mortality

96 hr

LC50

11.47

Mortality

96 hr

LC50

6.5

Mortality

96 hr

LC50

1.8

Mortality

96 hr

LC50

1.1

Mortality

96 hr

LC50

7.5

Mortality

96 hr

LC50

15.1

Mortality

Proposed Re-evaluation Decision – PRVD2015-01
Page 189

 Appendix X

Species Name or
Taxon
Lithobates
pipiens
Rana
sphenocephalia
Rana
sphenocephalia
Lithobates
sylvaticus
Lithobates
sylvaticus

Lithobates
sylvaticus
Rhinella
margaritifera
Rhinella
granulosa
Rhinella marina

Scinax ruber

Scinax nasicus

Scinax nasicus

Spea bombifrons

Spea bombifrons

Formulation
Type
Roundup®
original
formulation
Roundup
Weathermax
Roundup®
original
formulation
Roundup
Original® Max
Roundup
Original®/MON
78087 (15%
POEA)
Roundup
Original®/MON
78087 (15%
POEA)
Glyphos
+ Cosmo‐Flux
(10-15% POEA)
Glyphos
+ Cosmo‐Flux
(10-15% POEA)
Glyphos
+ Cosmo‐Flux
(10-15% POEA)
Glyphos
+ Cosmo‐Flux
(10-15% POEA)
Glyfos (48%
IPA and 15%
POEA)
Glyfos (48%
IPA and 15%
POEA)
RoundupWeatherMAX® (crop
playa)
RoundupWeatherMAX® (grass
playa)

Duration

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

96 hr

LC50

1.8

Mortality

96 hr

LC50

1.33

Mortality

96 hr

LC50

2.05

Mortality

96 hr

LC50

1.9

Mortality

96 hr

LC50

>8

Mortality

96 hr

LC50

5.1

Mortality

96 hr

LC50

1.5

Mortality

96 hr

LC50

2.3

Mortality

96 hr

LC50

2.7

Mortality

96 hr

LC50

1.6

Mortality

96 hr

LC50

0.94

Mortality

96 hr

LC50

0.94

Mortality

96 hr

LC50

1.85

Mortality

96 hr

LC50

2.03

Mortality

Proposed Re-evaluation Decision – PRVD2015-01
Page 190

 Appendix X

Species Name or
Taxon

Spea multiplicata

Spea multiplicata
Xenopus laevis
Xenopus laevis
Xenopus laevis
Xenopus laevis
Xenopus laevis
Xenopus laevis

Formulation
Type
RoundupWeatherMAX® (crop
playa)
RoundupWeatherMAX® (grass
playa)
Roundup with
POEA
Glyphos
+ Cosmo‐Flux
Vision® (15%
POEA) pH 7.5
Vision® (15%
POEA) pH 6
Vision® (15%
POEA) pH 7.5
Vision® (15%
POEA) pH 6

Duration

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

96 hr

LC50

2.11

Mortality

96 hr

LC50

2.3

Mortality

96 hr

LC50

9.3

Mortality

96 hr

LC50

1.3

Mortality

96 hr

LC50

0.88

Mortality

96 hr

LC50

2.1

Mortality

96 hr

LC50

14.6

Mortality

96 hr

LC50

15.6

Mortality

LC50

1.32

Mortality

LC50

6.8

Mortality

LC50

0.68

Mortality

LC50

0.83

Mortality

LC50
LC50

0.8
> 1.25

Mortality
Mortality

LC50

2.2

Mortality

NOEC

1.8

Highest limit
concentration

LC50

1.55

Mortality

LC50

1.63

Mortality

POEA Alone
Lithobates
MON 0818
96 hr
clamitans
Xenopus laevis
POEA
96 hr
Lithobates
MON 0818
96 hr
pipiens
Lithobates
MON 0818
96 hr
catesbeianus
Anaxyrus fowleri MON 0818
96 hr
Hyla chrysocelis MON 0818
96 hr
Lithobates
MON 0818
96 hr
clamitans
(69-73%)
Amphibians Subchronic and Chronic Data
Glyphosate Technical
Lithobates
Technical grade
42-d
pipiens
glyphosate IPA
Glyphosate Formulation (With POEA)
Roundup (IPA
Lithobates
with surfactant,
16-d
catesbeianus
corrected)
Roundup (IPA
Lithobates
with surfactant,
16-d
clamitans
corrected)

Proposed Re-evaluation Decision – PRVD2015-01
Page 191

 Appendix X

Species Name or
Taxon

Formulation
Type

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

16-d

LC50

1

Mortality

16-d

LC50

1.85

Mortality

16-d

LC50

1.89

Mortality

16-d

LC50

1

Mortality

96 hr

LC50

14.8

Mortality

96 hr

LC50

7.3

Mortality

96 hr

LC50

6.5

Mortality

96 hr

LC50

4.5

Mortality

96 hr

LC50

22.8

Mortality

96 hr

LC50

19.6

Mortality

96 hr

LC50

5.6

Mortality

96 hr

LC50

> 7.38

Mortality

96 hr

LC50

5.96

Mortality

96 hr

LC50

6.9

Mortality

96 hr

LC50

7.3

Mortality

96 hr

LC50

7.17

Mortality

Duration

Roundup (IPA
with surfactant,
corrected)
Roundup (IPA
Lithobates
with surfactant,
pipiens
corrected)
Roundup (IPA
Anaxyrus
with surfactant,
americanus
corrected)
Roundup (IPA
Lithobates
with surfactant,
sylvaticus
corrected)
Amphibian Terrestrial Microcosm
Glyphosate Formulation (With POEA)
Rhinella
Glyphos and
margaritifera
Cosmo-Flux
Glyphos and
Scinax ruber
Cosmo-Flux
Rhinella
Glyphos and
granulosa
Cosmo-Flux
Centrolene
Glyphos and
prosoblepon
Cosmo-Flux
Glyphos and
Rhinella marina
Cosmo-Flux
Engystomops
Glyphos and
pustulosus
Cosmo-Flux
Pristimantis
Glyphos and
taeniatus
Cosmo-Flux
Dendrobates
Glyphos and
truncatus
Cosmo-Flux
Amphibian Aquatic Field Microcosm
Glyphosate Formulation (With POEA)
Glyphos and
Rhinella marina
Cosmo-Flux
Glyphos and
Scinax ruber
Cosmo-Flux
Hypsiboas
Glyphos and
crepitans
Cosmo-Flux
Rhinella
Glyphos and
granulosa
Cosmo-Flux
Hyla versicolor

Reported
Endpoint

Proposed Re-evaluation Decision – PRVD2015-01
Page 192

 Appendix X

Species Name or
Taxon

Formulation
Type

Oyster embryo

Pacific Oyster
Mysid S hrimp

Glyphosate
(97% purity)
corrected
Glyphosate acid
(95.6% purity)

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

21-d

LC50

2.1

Mortality

21-d

LC50

2.44

Mortality

21-d

LC50

4.27

Mortality

21-d

LC50

2.31

Mortality

21-d

LC50

2.3

Mortality

21-d

LC50

3.93

Mortality

16-d

LC50

1.71

Mortality

16-d

LC50

1.61

Mortality

16-d

LC50

2.18

Mortality

14-d

LC50

> 0.55

Mortality
Embryo
abnormality
(32% effect at
0.005 mg a.e./L)

Duration

Amphibian Aquatic Field Mesocosm
Glyphosate Formulation (With POEA)
Roundup
Lithobates
Original Max®
sylvaticus
(Early applic.)
Roundup
Lithobates
Original Max®
sylvaticus
((Midday
applic.)
Roundup
Lithobates
Original Max®
sylvaticus
(Late applic.)
Roundup
Anaxyrus
Original Max®
americanus
(Early applic.)
Roundup
Anaxyrus
Original Max®
americanus
(Midday applic.)
Roundup
Anaxyrus
Original Max®
americanus
(Late applic.)
Roundup
Hyla versicolor
Original Max®
(high density)
Roundup
Lithobates
Original Max®
catesbeianus
(high density)
Roundup
Lithobates
Original Max®
clamitans
(high density)
Lithobates
Vision Max
clamitans
(540 g a.e/L)
Glyphosate Technical
Glyphosate
technical

Reported
Endpoint

24 hr

EC50

> 0.005

48 hr

EC50

> 97

96 hr

LC50

80

Proposed Re-evaluation Decision – PRVD2015-01
Page 193

Metamorphic
success
Mortality

 Appendix X

Species Name or
Taxon

Formulation
Type

Toxicity
Value
(mg
a.e./L)*

96 hr

EC50

934

Mean carapace
width

96 hr

EC50

281

Mean length

48 hr

EC50

40

48 hr

EC50

27.5

48 hr

EC50

> 10

Larval
development

48 hr
48 hr

LC50
LC50

35.3
49.3

Mortality
Mortality

48 hr

EC50

23.2

Laraval
development

96 hr

EC50

> 54

Mortality

24 hr

LC50

158.6

Juvenile
mortality

48 hr

EC50

6.9

Metamorphic
success

48 hr

EC50

7.6

Metamorphic
success

48 hr

LC50

1.8

Duration

Roundup
Technical
(96.7% purity)
Roundup
Grass Shrimp
Technical
(96.7% purity)
Glyphosate acid
Pacific Oyster
(95.6% purity)
glyphosate (97%
Pacific Oyster
purity)
Roundup
Atlantic Oyster
Technical
(embryo)
(96.7% purity)
Acartia tonsa
Glyphosate acid
Acartia tonsa
Glyphosate IPA
Glyphosate Formulation (Non-POEA)
Glyphosate SL
Pacific Oyster
(YF11357)
28.3%
Glyphosate SL
Mysid Shrimp
(YF11357)
28.3%
Glyphosate Formulation (With POEA)
Roundup Pro
Blue crab
(50.2% IPA)
POEA)
Roundup
Pacific Oyster
Express
(7.3 g a.i./L)
Roundup Allées
Pacific Oyster
et Terrasses (4.4
g a.i./L)
Acartia tonsa
Roundup
Fiddler Crab

Reported
Endpoint

Measurement
Endpoint

Larval
development
Larval
development

Mortality
Highest tested
concentration

Oyster embryo

Roundup

24 hr

EC50

> 0.005

Atlantic Oyster
(embryo)

MON 2139
Roundup®
(30.75 % a.e.)

48 hr

EC50

1

POEA Alone
Acartia tonsa
AMPA

POEA

48 hr

LC50

0.6

Mortality

Pacific Oyster

AMPA

48 hr

EC50

> 97

Metamorphic
success

Proposed Re-evaluation Decision – PRVD2015-01
Page 194

shell
development

 Appendix X

Species Name or
Taxon

Formulation
Type

Estuarine/Marine Fish Acute Data
Glyphosate Technical
Glyphosate
Sheepshead
technical (95.6%
minnow
purity)
Glyphosate
Chinook salmon
technical (city)
Glyphosate
Chinook salmon
technical (creek)
Glyphosate
Chinook salmon
technical
(reconstituted)
Glyphosate
Chinook salmon
technical (well)
Glyphosate
Chinook salmon
technical (lake)
Glyphosate
Coho salmon
technical (city)
Glyphosate
Coho salmon
technical (creek)
Glyphosate
Coho salmon
technical
(reconstituted)
Glyphosate
Coho salmon
technical (well)
Glyphosate
Coho salmon
technical (lake)
Glyphosate
Chum salmon
technical (city)
Glyphosate
Chum salmon
technical (creek)
Glyphosate
Chum salmon
technical
(reconstituted)
Glyphosate
Chum salmon
technical (lake)
Glyphosate
Pink salmon
technical (city)
Glyphosate
Pink salmon
technical (creek)
Glyphosate
Pink salmon
technical
(reconstituted)

Duration

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

96 hr

LC50

247

Mortality

96 hr

LC50

19

Mortality

96 hr

LC50

30

Mortality

96 hr

LC50

102

Mortality

96 hr

LC50

108

Mortality

96 hr

LC50

211

Mortality

96 hr

LC50

27

Mortality

96 hr

LC50

36

Mortality

96 hr

LC50

112

Mortality

96 hr

LC50

111

Mortality

96 hr

LC50

174

Mortality

96 hr

LC50

10

Mortality

96 hr

LC50

22

Mortality

96 hr

LC50

99

Mortality

96 hr

LC50

148

Mortality

96 hr

LC50

14

Mortality

96 hr

LC50

23

Mortality

96 hr

LC50

94

Mortality

Proposed Re-evaluation Decision – PRVD2015-01
Page 195

 Appendix X

Species Name or
Taxon

Formulation
Type

Duration

Glyphosate
96 hr
technical (well)
Glyphosate
Pink salmon
96 hr
technical (lake)
Glyphosate Formulation (Non-POEA)
Chinook salmon
96 hr
Rodeo® + X‐77
Chinook salmon
96 hr
Rodeo® + X‐77
Coho salmon
96 hr
Rodeo® + X‐77
Glyphosate Formulation (With POEA)
Chinook salmon
Roundup®
96 hr
Roundup®
Chinook salmon
(Vision®)
96 hr
30.5%
Roundup®
Chinook salmon
(Vision®)
96 hr
30.5%
Roundup®
Chinook salmon
(Vision®)
96 hr
30.5%
Roundup®
Chinook salmon
(Vision®)
96 hr
30.5%
Roundup®
Chinook salmon
(Vision®)
96 hr
30.5%
MON 8709
Chinook salmon
96 hr
30.5%
MON 8709
Chinook salmon
96 hr
30.5%
MON 8709
Chinook salmon
96 hr
30.5%
MON 8709
Chinook salmon
96 hr
30.5%
MON 8709
Chinook salmon
96 hr
30.5%
Chinook salmon
Roundup®
96 hr
Coho salmon
Roundup®
96 hr
Roundup®
Coho salmon
96 hr
(Vision®)
Roundup®
Coho salmon
96 hr
(Vision®)
Roundup®
Coho salmon
96 hr
(Vision®)
Pink salmon

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

LC50

102

Mortality

LC50

190

Mortality

LC50
LC50
LC50

103.8
180.2
148.3

Mortality
Mortality
Mortality

LC50

7.1

Mortality

LC50

5.8

Mortality

LC50

8.2

Mortality

LC50

10

Mortality

LC50

5.2

Mortality

LC50

6.7

Mortality

LC50

8.54

Mortality

LC50

13.7

Mortality

LC50

18.9

Mortality

LC50

20.4

Mortality

LC50

10.1

Mortality

LC50
LC50

7.1
8.1

Mortality
Mortality

LC50

8.2

Mortality

LC50

9.2

Mortality

LC50

10

Mortality

Proposed Re-evaluation Decision – PRVD2015-01
Page 196

 Appendix X

Species Name or
Taxon
Coho salmon
Coho salmon
Coho salmon
Coho salmon
Coho salmon
Coho salmon
Coho salmon
Coho salmon
(fry)
Chum salmon
Chum salmon
Chum salmon
Chum salmon
Chum salmon
Chum salmon
Chum salmon
Chum salmon
Pink salmon
Pink salmon
Pink salmon
Pink salmon
Pink salmon
Pink salmon
Pink salmon
Pink salmon
Pink salmon
Pink salmon
Sockeye salmon
Sockeye salmon
Sockeye salmon
(fry)

Formulation
Type
Roundup®
(Vision®)
Roundup®
(Vision®)
MON 8709
MON 8709
MON 8709
MON 8709
MON 8709
Roundup®
Roundup®
(Vision®)
Roundup®
(Vision®)
Roundup®
(Vision®)
Roundup®
(Vision®)
MON 8709
MON 8709
MON 8709
MON 8709
Roundup®
(Vision®)
Roundup®
(Vision®)
Roundup®
(Vision®)
Roundup®
(Vision®)
Roundup®
(Vision®)
MON 8709
MON 8709
MON 8709
MON 8709
MON 8709
Roundup®
Roundup®
Roundup®

Duration

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

96 hr

LC50

4

Mortality

96 hr

LC50

9

Mortality

96 hr
96 hr
96 hr
96 hr
96 hr

LC50
LC50
LC50
LC50
LC50

13.4
15.6
16.8
7.6
10.4

Mortality
Mortality
Mortality
Mortality
Mortality

96 hr

LC50

12.8

Mortality

96 hr

LC50

5.8

Mortality

96 hr

LC50

3.4

Mortality

96 hr

LC50

6.1

Mortality

96 hr

LC50

4.6

Mortality

96 hr
96 hr
96 hr
96 hr

LC50
LC50
LC50
LC50

11
7
10.4
17.7

Mortality
Mortality
Mortality
Mortality

96 hr

LC50

5.8

Mortality

96 hr

LC50

4.3

Mortality

96 hr

LC50

10.1

Mortality

96 hr

LC50

9.5

Mortality

96 hr

LC50

5.2

Mortality

96 hr
96 hr
96 hr
96 hr
96 hr
96 hr
96 hr

LC50
LC50
LC50
LC50
LC50
LC50
LC50

14
14.6
10.4
7.9
7.3
8.1
8.4

Mortality
Mortality
Mortality
Mortality
Mortality
Mortality
Mortality

96 hr

LC50

8.7

Mortality

Proposed Re-evaluation Decision – PRVD2015-01
Page 197

 Appendix X

Species Name or
Taxon
Sheepshead
minnow

Formulation
Type
MON 2139
Roundup®
30.75%

Duration

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

96 hr

LC50

2.7

Mortality

96 hr

LC50

2.8

Mortality

96 hr

LC50

2.8

Mortality

96 hr

LC50

2.7

Mortality

96 hr

LC50

2.6

Mortality

96 hr

LC50

1.7

Mortality

96 hr

LC50

4.6

Mortality

96 hr

LC50

3.2

Mortality

96 hr

LC50

2.8

Mortality

96 hr

LC50

2.9

Mortality

96 hr

LC50

1.8

Mortality

96 hr

LC50

3.5

Mortality

96 hr

LC50

2.7

Mortality

96 hr

LC50

2.6

Mortality

96 hr

LC50

1.4

Mortality

96 hr

LC50

2.6

Mortality

96 hr

LC50

4.5

Mortality

96 hr

LC50

2.8

Mortality

96 hr

LC50

1.5

Mortality

96 hr

LC50

2.6

Mortality

POEA Alone
Chinook salmon
Chinook salmon
Chinook salmon
Chinook salmon
Chinook salmon
Coho salmon
Coho salmon
Coho salmon
Coho salmon
Coho salmon
Coho salmon
(fry)
Chum salmon
Chum salmon
Chum salmon
Chum salmon
Pink salmon
Pink salmon
Pink salmon
Pink salmon

MON 0818
(city)
MON 0818
(creek)
MON 0818
(reconstituted)
MON 0818
(well)
MON 0818
(lake)
MON 0818
(city)
MON 0818
(creek)
MON 0818
(reconstituted)
MON 0818
(well)
MON 0818
(lake)
MON 0818
MON 0818
(city)
MON 0818
(creek)
MON 0818
(reconstituted)
MON 0818
(lake)
MON 0818
(city)
MON 0818
(creek)
MON 0818
(reconstituted)
MON 0818
(well)

Proposed Re-evaluation Decision – PRVD2015-01
Page 198

 Appendix X

Species Name or
Taxon
Pink salmon

Duration

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

Measurement
Endpoint

96 hr

LC50

1.4

Mortality

96 hr

LC50

2.6

Mortality

42-d

NOEC

0.1

Mortality and
Length

96 hr

EC50

11

Biomass

96 hr

IC50

2.27

96 hr

IC50

5.89

7-d

EC50

0.64

Roundup

96 hr

EC50

1.85

Growth
inhibition

POEA

96 hr

EC50

3.35

Growth
inhibition

21-d

EC50

62.33

21-d

EC50

292.3

21-d

EC50

101.18

21-d

EC50

> 169

21-d

EC50

61.8

21-d

EC50

> 169

21-d

EC50

44.48

Formulation
Type
MON 0818
(lake)

Sockeye salmon
MON 0818
(fry)
Estuarine/Marine Fish Chronic Data
Glyphosate Technical
Threespine
Glyphosate
stickleback
(≥ 96%)
Marine Algae Acute Data
Glyphosate Technical
Glypohsate
S. costatum
technical
Glypohsate
S. costatum
technical
Glypohsate
S. costatum
technical
Glypohsate
S. costatum
technical
Glyphosate Formulation (With POEA)
S. costatum

Growth
inhibition
Growth
inhibition
Growth
inhibition

POEA Alone
S. costatum

Marine Algae Chronic Data
Glyphosate Technical
Chlorella
Glypohsate
vulgaris
technical
Chlorella
Glypohsate
vulgaris
technical
Spirulina
Glypohsate
plastensis
technical
Spirulina
Glypohsate
plastensis
technical
Arthrospira
Glypohsate
fusiformis
technical
Arthrospira
Glypohsate
fusiformis
technical
Nostoc
Glypohsate
punctiforme
technical

Proposed Re-evaluation Decision – PRVD2015-01
Page 199

Growth
inhibition
Growth
inhibition
Growth
inhibition
Growth
inhibition
Growth
inhibition
Growth
inhibition
Growth
inhibition

 Appendix X

Species Name or
Taxon

Formulation
Type

Reported
Endpoint

Toxicity
Value
(mg
a.e./L)*

21-d

EC50

598.4

21-d

EC50

5.33

21-d

EC50

256.5

21-d

EC50

174.75

21-d

EC50

164.9

21-d

EC50

8.03

21-d

EC50

251.4

21-d

EC50

6.68

21-d

EC50

246.6

21-d

EC50

21.26

21-d

EC50

5.96

21-d

EC50

5.08

21-d

EC50

7.61

21-d

EC50

0.52

21-d

EC50

16.16

21-d

EC50

1.21

21-d

EC50

0.74

Duration

Nostoc
Glypohsate
punctiforme
technical
Anabaena
Glypohsate
catenula
technical
Anabaena
Glypohsate
catenula
technical
Synechocystis
Glypohsate
aquatilis
technical
Synechocystis
Glypohsate
aquatilis
technical
Microcystis
Glypohsate
eruginosa
technical
Microcystis
Glypohsate
eruginosa
technical
Leptolynbya
Glypohsate
boryana
technical
Leptolynbya
Glypohsate
boryana
technical
Glyphosate Formulation (With POEA)
Chlorella
vulgaris
Spirulina
plastensis
Arthrospira
fusiformis
Nostoc
punctiforme
Anabaena
catenula
Synechocystis
aquatilis
Microcystis
eruginosa
Leptolynbya
boryana

Proposed Re-evaluation Decision – PRVD2015-01
Page 200

Measurement
Endpoint
Growth
inhibition
Growth
inhibition
Growth
inhibition
Growth
inhibition
Growth
inhibition
Growth
inhibition
Growth
inhibition
Growth
inhibition
Growth
inhibition
Growth
inhibition
Growth
inhibition
Growth
inhibition
Growth
inhibition
Growth
inhibition
Growth
inhibition
Growth
inhibition
Growth
inhibition

 Appendix X

Table X.17

Summary of Species Sensitivity Distributions (SSDs) for Glyphosate, Its
Major Tramsformation Product AMPA and the Formulant POEA: HC5 OR
Most Sensitive Species by Taxonomic Group: Fish, Aquatic Invertebrates,
Amphibians, AquaticPlants, Algae and Terrestrial Plants

Terrestrial and
Aquatic
Organisms

Glyphosate
Technical

Glyphosate
Formulation
(Non-POEA)

Acute

Acute

Glyphosate
Formulation
(With POEA)

AMPA

POEA1

Exposure
Chronic

Chronic

Acute

Chronic

Acute

Acute

Chronic

Terrestrial Organisms
Earthworms
(mg ae./kg soil)
Snails (mg ae./L)
Terrestrial
Plants (SE) EC50
(kg ae/ha)
Terrestrial
Plants (VV)
EC25 (kg ae/ha)
Terrestrial
Plants (VV)
EC50 (kg ae/ha)
Terrestrial
Plants (VV)
EC50 Non-crop
(kg ae/ha)
Terrestrial
Plants EC50
Mixed
(kg ae/ha)
Terrestrial
Plants EC25
Mixed
(kg a.e/ha)
Aquatic Organisms
Freshwater
Invertebrates
(mg ae/L)
Freshwater Fish
(mg ae./L)
Freshwater

690X

—

—

0.253X

—

—

—

—

NOEC:
1000

—

NOEC:
29.7
(NOEC:
219 mg
a.e./kg
soil)

LC50:
2.3X

NOEC: 8.55

—

—

—

EC50: 3.25X

—

EC50:
4.48X

—

—

—

—

—

—

HC5: 0.12

—

HC5:
0.0664

—

—

—

—

—

—

HC5: 0.27

—

—

—

—

—

—

—

—

—

—

HC5:0.0
126

—

—

—

—

—

—

—

—

EC50:
0.014X

—

—

—

—

—

—

—

—

—

—

HC5:
0.035

—

—

—

—

—

HC5: 16.9

HC5: 80.4
HC5: 6.55

—

HC5:
30.5

EC50:
43.8x

HC5:
0.19

NOEC:
0.269

LC50:
408.2x

HC5:
0.0041

EC50:
1.7x

25.7

LC50:
122.3X

—

—

—

—

—

—

HC5:
118.2

EC50:
0.12X

—

EC50:
9.1X

HC5:0.42

EC50:
143X

EC50:
3.35X

EC50:
3.35X

NOEC:

7.1
NOEC:

Proposed Re-evaluation Decision – PRVD2015-01
Page 201

 Appendix X

Glyphosate
Technical

Glyphosate
Formulation
(Non-POEA)

Acute

Chronic

Acute

Chronic

Acute

Chronic

Acute

Acute

Chronic

EC50: 21.1X

—

EC50:
7.7X

—

HC5:
0.003

—

—

—

—

HC5:
18.1

—

HC5:
0.93

HC5 (LC50):
0.86

—

HC5:
0.35

—

HC5 (LC50):
1.36,
NOEC: 0.55

—

—

—

Terrestrial and
Aquatic
Organisms

Glyphosate
Formulation
(With POEA)

AMPA

POEA1

Exposure

Algae (mg ae/L)
Freshwater
Plants (mg ae/L)
Amphibians (mg
ae/L)
Amphibians –
Mesocosm (mg
a.e./L)
Marine
Invertebrates
(mg a.e./L)
Marine Fish
(mg a.e./L)
Marine algae
(mg a.e./L)

HC5: 14.9

NOEC:

1.8

—

—

—

—

HC5:
2.29
(HC5:
3.28 kg
a.e./ha)

HC5: 0.3

—

EC50:
23.2x

—

HC5: 0.1

—

EC50: 97x

EC50:
0.6x

—

0.1

LC50:
136.8X

—

HC5:
3.04

—

—

HC5:
2.06

—

HC5:
28.4

—

—

EC50:
3.35x

HC5: 0.33

—

EC50:
1.85

EC50:
1.85

HC5: 23.4
EC50: 3.11x

NOEC:

X

Not an HC5 value, SSDs could not be determined, the most sensitive species endpoint value is reported and uncertainty
factor to be applied as required; 1POEA: formulant, POEA concentrations cannot be directly compared to other data; SE =
Seedling emergence, VV = Vegetative vigour.

Table X.18

Risk Quotients for Earthworms and the Soil Benefecials Exposed to the
Glyphosate Technical, Glyphosate Formulations and the Transformation
Product AMPA
Endpoints
(mg a.e./kg
soil)

Crop

EEC (mg a.e./kg soil)

Acute

1/2LC50: 163.9

Apple

4.24

0.03

No

Acute

1/2LC50: >
2129

Apple
Potato
Apple
Potato

4.24
1.92
4.24
1.92

< 0.002
< 0.001
0.2
0.09

No
No
No
No

Apple

4.24

< 0.009

No

Acute
1/2LC50: > 500 Apple
Chronic NOEC: 28.12
Apple
Springtail (collembolan), Folsomia candida
Glyphosate
Formulation
Acute
EC50/2 = 0.57
Apple
(POEA
48-h
mg a.e./kg soil
Unknown)

3.5
3.5

< 0.007
0.12

No
No

7.4

Yes

0.2

No

Test Material
Earthworms
Glyphosate
Technical
Glyphosate
Formulation
(With POEA)
Glyphosate
Formulation
(POEA
Unknown)
AMPA

Exposure

Chronic

Acute

NOEC: 21.3

1/2LC50: > 500

In-field: 4.24 mg a.e./kg
soil
Off-field (ground
application,

Proposed Re-evaluation Decision – PRVD2015-01
Page 202

Level of
Concern
Exceeded

RQ1

 Appendix X

Test Material

Exposure

Endpoints
(mg a.e./kg
soil)

Crop

Canola

Potato

Apple

Chronic
EC50/2 = 0.27
– Repro- mg a.e./kg soil
duction (In the absence
- 28 d
of a NOEC)

Canola

Potato

EEC (mg a.e./kg soil)
3% drift):0.13 mg
a.e./kg soil
Refinement In-field (0.6
soil deposition factor):
2.544 mg a.e./kg soil
In-field: 3.47 mg a.e./kg
soil
Off-field (ground
application, 3%
drift):0.10 mg a.e./kg
soil
Off-field (aerial
application, 17%
drift):0.59 mg a.e./kg
soil
Refinement In-field (0.6
soil deposition factor):
2.082 mg a.e./kg soil
In-field: 1.92 mg a.e./kg
soil
Off-field (ground
application, 3% drift):
0.06 mg a.e./kg soil
Refinement In-field (0.6
soil deposition factor):
1.152 mg a.e./kg soil
In-field: 4.24 mg a.e./kg
soil
Off-field (ground
application, 3%
drift):0.13 mg a.e./kg
soil
Refinement In-field (0.6
soil deposition factor):
2.544 mg a.e./kg soil
In-field: 3.47 mg a.e./kg
soil
Off-field (ground
application, 3%
drift):0.10 mg a.e./kg
soil
Off-field (aerial
application, 17%
drift):0.59 mg a.e./kg
soil
Refinement In-field (0.6
soil deposition factor):
2.082 mg a.e./kg soil
In-field: 1.92 mg a.e./kg
soil
Off-field (ground
application, 3% drift):
0.06 mg a.e./kg soil

Proposed Re-evaluation Decision – PRVD2015-01
Page 203

Level of
Concern
Exceeded

RQ1

4.45

Yes

6.1

Yes

0.2

No

1

Marginal

3.78

Yes

3.43

Yes

0.01

No

2

Yes

15.7

Yes

0.5

No

9.4

Yes

13

Yes

0.4

No

2.2

Yes

7.7

Yes

7.1

Yes

0.2

No

 Appendix X

Test Material

Exposure

Endpoints
(mg a.e./kg
soil)

Crop

EEC (mg a.e./kg soil)

Refinement In-field (0.6
soil deposition factor):
1.152 mg a.e./kg soil
1
Shaded cells and bold values indicate that the level of concern is exceeded (RQ > 1).

Table X.19

Organism

Level of
Concern
Exceeded

RQ1

4.3

Yes

Screening and Refinement Level Risk Assessment and Risk Quotients for
Bees and Predators and Parasitic Arthropods Exposed to the Glyphosate
Technical, Glyphosate Formulations and the Transformation Product AMPA
Endpoint
Exposure
Crop
Value

EEC

RQ

1

Level of
Concern
Exceeded

Bee
Glyphosate Technical
LD50 >
4.32 kg a.e./ha × 2.4 µg
Contact
182 µg
a.e./bee per kg a.e./ha =
< 0.06
No
a.e./bee
—
10.37 µg a.e./bee
LD50 >
4.32 kg a.e./ha × 29 µg
Honeybee,
Oral
182 µg
a.e./bee per kg a.e./ha =
< 0.7
No
a.e./bee
—
125.28 µg a.e./bee
Apis melifera
Risk is not expected from exposure to glyphosate based on the mode
Brood /
of action, a lack of effects observed for adult bees, and a lack of
hive
significant effects to other immature insects (chironomid and
beneficial arthropods).
Gyphosate Formulation (With POEA)
LD50 >
4.32 kg a.e./ha × 2.4 µg
Contact
182 µg
a.e./bee per kg a.e./ha =
< 0.09
No
a.e./bee
—
10.37 µg a.e./bee
LD50 >
4.32 kg a.e./ha × 29 µg
Oral
116 µg
a.e./bee per kg a.e./ha =
< 1.25
No
EUP + POEA
a.e./bee
—
125.28 µg a.e./bee
Risk is not expected from exposure to glyphosate based on the mode
Brood /
of action, a lack of effects observed for adult bees, and a lack of
hive
significant effects to other immature insects (chironomid and
beneficial arthropods).
Arthropods
In-field: 7285 g a.e./ha
45.0
Yes
Off-field (ground
Apple
application, 3% drift): 29
1.3
Predatory
g a.e./ha
No
Contact, LR50 =
arthropod,
glass
161.9 g
In-field: 6990 g a.e./ha
43.0
Yes
Typhlodromus
plate
a.e./ha
Off-field (ground
pyri
Canola application, 3% drift):
1.3
210Vg a.e./ha
No
Off-field (aerial
7.3
Yes

Proposed Re-evaluation Decision – PRVD2015-01
Page 204

 Appendix X

Organism

Exposure

Endpoint
Crop
Value

Potato

Apple

Contact,
leaf
substrate

LR50 =
1567 g
a.e./ha

Canola

Potato

EEC
application, 17% drift):
1188 g a.e./ha
In-field: 4320 g a.e./ha
Off-field (ground
application, 3% drift):
130 g a.e./ha
In-field: 7285 g a.e./ha
Off-field (ground
application, 3% drift):
219 g a.e./ha
Refined In-field (0.4 foliar
deposition factor):
2914 g a.e./ha
In-field: 6990 g a.e./ha
Off-field (ground
application, 3% drift):
210 g a.e./ha
Off-field (aerial
application, 17% drift):
1188 g a.e./ha
Refined In-field (0.4 foliar
deposition factor):
2796 g a.e./ha
In-field: 4320 g a.e./ha
Off-field (ground
application, 3% drift):
130 g a.e./ha
Refined In-field (0.4 foliar
deposition factor):
1728 g a.e./ha

Proposed Re-evaluation Decision – PRVD2015-01
Page 205

RQ1

27.0

Level of
Concern
Exceeded

Yes

0.8
4.7

No
Yes

0.1
No
1.9
4.5

Yes
Yes

0.1
No
0.8
No
1.8
2.8

Yes
Yes

0.08
No
1.1
No

 Appendix X

Organism

Exposure

Endpoint
Crop
Value

Apple

Contact,
glass
plate

LR50 =
2267 g
a.e./ha

Canola

Potato

Parasitoid
arthropod,
Aphidius
rhopalosiphi

Apple

Contact,
leaf
substrate

LR50 >
5976 g
a.e./ha;
ER50 >
5976 g
a.e./ha

Canola

Potato

Lacewing,
Chrysoperla
carnea

Contact,
glass
plate

LR50 >
5976 g
a.e./ha;
ER50 >
5976 g
a.e./ha

Apple

Canola

EEC
In-field: 7285 g a.e./ha
Off-field (ground
application, 3% drift):
219 g a.e./ha
In-field: 6990 g a.e./ha
Off-field (ground
application, 3% drift):
210 g a.e./ha
Off-field (aerial
application, 17% drift):
1188 g a.e./ha
In-field: 4320 g a.e./ha
Off-field (ground
application, 3% drift):
130 g a.e./ha
In-field: 7285 g a.e./ha
Off-field (ground
application, 3% drift):
219 g a.e./ha
Refined In-field (0.4 foliar
dissipation factor):
2914 g a.e./ha
In-field: 6990 g a.e./ha
Off-field (ground
application, 3% drift):
210 g a.e./ha
Off-field (aerial
application, 17% drift):
1188 g a.e./ha
Refined In-field (0.4 foliar
deposition factor):
2796 g a.e./ha
In-field: 4320 g a.e./ha
Off-field (ground
application, 3% drift):
130 g a.e./ha
In-field: 7285 g a.e./ha
Off-field (ground
application, 3% drift):
219 g a.e./ha
Refined In-field (0.4 foliar
deposition factor):
2914 g a.e./ha
In-field: 6990 g a.e./ha

Proposed Re-evaluation Decision – PRVD2015-01
Page 206

Level of
Concern
Exceeded
3.2
Yes

RQ1

0.1
3.1

No
Yes

0.09
No
0.5
1.9

No
No

0.06
< 1.2

No
No

< 0.04
No
< 0.5
< 1.2

No
No

< 0.04
No
< 0.2
No
< 0.5
< 0.7

No
No

< 0.02
< 1.2

No
Yes

< 0.04
No
< 0.5
< 1.2

No
Yes

 Appendix X

Organism

Exposure

Endpoint
Crop
Value

Potato

Apple

Hoverfly,
Episyrphus
balteatus

Contact,
leaf
substrate

LR50 >
5976 g
a.e./ha;
ER50
>5976 g
a.e./ha

Canola

Potato

Carabid
beetle,
Poecilus
cupreus

Contact,
sand
substrate

LR50 >
2988 g
a.e./ha;
ER50 >
2988 g
a.e./ha

Apple

Canola

EEC
Off-field (ground
application, 3% drift):
210 g a.e./ha
Off-field (aerial
application, 17% drift):
1188 g a.e./ha
Refined In-field (0.4 foliar
deposition factor):
2796 g a.e./ha
In-field: 4320 g a.e./ha
Off-field (ground
application, 3% drift): 130
g a.e./ha
In-field: 7285 g a.e./ha
Off-field (ground
application, 3% drift):
219 g a.e./ha
Refined In-field (0.4 foliar
deposition factor):
2914 g a.e./ha
In-field: 6990 g a.e./ha
Off-field (ground
application, 3% drift):
210 g a.e./ha
Off-field (aerial
application, 17% drift):
1188 g a.e./ha
Refined In-field (0.4 foliar
deposition factor):
2796 g a.e./ha
In-field: 4320 g a.e./ha
Off-field (ground
application, 3% drift):
130 g a.e./ha
In-field: 7285 g a.e./ha
Off-field (ground
application, 3% drift):
219 g a.e./ha
Refined In-field (0.6 soil
deposition factor):
4371 g a.e./ha
In-field: 6990 g a.e./ha
Off-field (ground
application, 3% drift):

Proposed Re-evaluation Decision – PRVD2015-01
Page 207

RQ1

Level of
Concern
Exceeded

< 0.04
No
< 0.2
No
< 0.5
< 0.7

No
No

< 0.02
< 1.2

No
Yes

< 0.04
No
< 0.5
< 1.2

No
Yes

< 0.04
No
< 0.2
No
< 0.5
< 0.7

No
No

< 0.02
< 2.4

No
Yes

< 0.07
No
< 1.5
< 2.3
< 0.07

Yes
Yes
No

 Appendix X

Organism

Exposure

Endpoint
Crop
Value

Potato

Apple

Staphynilid
beetle,
Aleochara
bilineata

Chronic,
soil
substrate

NOER =
5976 g
a.e./ha,
highest
rate
tested

Canola

Potato
1

EEC
210 g a.e./ha
Off-field (aerial
application, 17% drift):
1188 g a.e./ha
Refined In-field (0.6 soil
deposition factor):
4194 g a.e./ha
In-field: 4320 g a.e./ha
Off-field (ground
application, 3% drift):
130 g a.e./ha
Refined In-field (0.6 soil
dissipation factor):
2592 g a.e./ha
In-field: 7285 g a.e./ha
Off-field (ground
application, 3% drift):
219 g a.e./ha
In-field: 6990 g a.e./ha
Off-field (ground
application, 3% drift):
210 g a.e./ha
Off-field (aerial
application, 17% drift):
1188 g a.e./ha
In-field: 4320 g a.e./ha
Off-field (ground
application, 3% drift):
130 g a.e./ha

RQ1

Level of
Concern
Exceeded

< 0.4
No
< 1.4
Yes
Yes

< 1.4
< 0.04

No
< 0.9
1.2

No
Yes

0.04

No

1.1

Yes

0.04
No
0.2
No
No

0.7
0.02

No

Risk Quotient (RQ) = EEC/endpoint; shaded cells and bold values indicate that the screening level RQ exceeds the
LOC of 2.0 for A. rhopalosiphi and T. pyri and 1.0 for others.

Table X.20

Animal Size

Screening Level Risk Assessment for Birds and Mammals Exposed to
Glyphosate Technical
Toxicity (mg
a.e/kg bw/d)

Feeding Guild
(Food Item)

Screening Level – Birds
Small Bird (0.02 kg)
Acute
> 319.63
Insectivore
Reproduction
291
Insectivore
Medium-Sized Bird (0.1 kg)
Acute
> 319.63 Insectivore

EDE (mg
a.e/kg bw)

RQ

Level of
Concern
Exceeded

592.97
592.97

< 1.9
2

Yes
Yes

462.75

< 1.5

Yes

Proposed Re-evaluation Decision – PRVD2015-01
Page 208

 Appendix X

Animal Size

Toxicity (mg
a.e/kg bw/d)

Feeding Guild
(Food Item)

Reproduction
291
Insectivore
Large-Sized Bird (1 kg)
Acute
> 319.63 Herbivore (short grass)
Reproduction
291
Herbivore (short grass)
Screening Level – Mammals
Small Mammal (0.015 kg)
Acute
156.8
Insectivore
Reproduction
740
Insectivore
Medium-Sized Mammal (0.035 kg)
Acute
156.8
Herbivore (short grass)
Reproduction
740
Herbivore (short grass)
Large-Sized Mammal (1 kg)
Acute
156.8
Herbivore (short grass)
Reproduction
740
Herbivore (short grass)

EDE (mg
a.e/kg bw)

RQ

462.75

1.6

Level of
Concern
Exceeded
Yes

298.91
298.91

< 0.9
1

No
Marginal

341.06
341.06

2.2
0.5

Yes
No

661.47
661.47

4.2
0.9

Yes
No

353.45
353.45

2.3
0.5

Yes
No

Shaded cells and bold values indicate that the level of concern is exceeded (RQ > 1).

Proposed Re-evaluation Decision – PRVD2015-01
Page 209

 Appendix X

Table X.21

Exposure

Risk Assessment Refinement for Birds Exposed to Glyphosate Technical

Toxicity
(mg
a.e./kg
bw/d)

Food Guild (Food Item)

Small Bird (0.02 kg)
> 319.63
Insectivore
Acute
> 319.63 Granivore (grain and seeds)
> 319.63
Frugivore (fruit)
> 258.00
Insectivore
Dietary
> 258.00 Granivore (grain and seeds)
> 258.00
Frugivore (fruit)
291
Insectivore
Reproduction
291
Granivore (grain and seeds)
291
Frugivore (fruit)
Medium-Sized Bird (0.1 kg)
> 319.63
Insectivore
Acute
> 319.63 Granivore (grain and seeds)
> 319.63
Frugivore (fruit)
> 258.00
Insectivore
Dietary
> 258.00 Granivore (grain and seeds)
> 258.00
Frugivore (fruit)
291
Insectivore
Reproduction
291
Granivore (grain and seeds)
291
Frugivore (fruit)
Large-Sized Bird (1 kg)
>319.63
Insectivore
Acute
>319.63 Granivore (grain and seeds)

Maximum Nomogram Residues
Off-field
On-field
(3% drift)
EDE (mg RQ EDE (mg RQ
a.e./kg bw)
a.e./kg
bw)

Mean Nomogram Residues
Off-field
On-field
(3% drift)
EDE (mg RQ EDE (mg RQ
a.e./kg bw)
a.e./kg
bw)

592.97
91.77
183.54
592.97
91.77
183.54
592.97
91.77
183.54

< 1.9
< 0.3
< 0.6
< 2.3
< 0.4
< 0.7
2.0
0.3
0.6

17.79
2.75
5.51
17.79
2.75
5.51
17.79
2.75
5.51

< 0.06
< 0.01
< 0.02
< 0.07
< 0.01
< 0.02
0.06
0.01
0.02

409.43
43.77
87.53
409.43
43.77
87.53
409.43
43.77
87.53

< 1.3
< 0.1
< 0.3
< 2.0
< 0.2
< 0.3
1.4
0.2
0.3

12.28
1.31
2.63
12.28
1.31
2.63
12.28
1.31
2.63

< 0.04
< 0.004
< 0.01
< 0.05
< 0.01
< 0.01
< 0.04
< 0.005
0.01

462.75
71.62
143.23
462.75
71.62
143.23
462.75
71.62
143.23

< 1.5
< 0.2
< 0.5
< 1.8
< 0.3
< 0.6
1.6
0.3
0.5

13.88
2.15
4.3
13.88
2.15
4.3
13.88
2.15
4.3

< 0.04
< 0.01
< 0.01
< 0.05
< 0.01
< 0.02
0.05
0.01
0.01

319.52
34.16
68.31
319.52
34.16
68.31
319.52
34.16
68.31

< 1.0
< 0.1
< 0.2
< 1.2
< 0.1
< 0.3
1.1
0.1
0.2

9.59
1.02
2.05
9.59
1.02
2.05
9.59
1.02
2.05

< 0.03
< 0.003
< 0.01
< 0.04
< 0.004
< 0.01
0.03
0.004
0.01

135.1
20.91

< 0.4
< 0.1

4.05
0.63

< 0.01
< 0.002

93.29
93.29

< 0.3
< 0.3

2.8
0.3

< 0.01
< 0.001

Proposed Re-evaluation Decision – PRVD2015-01
Page 210

 Appendix X

Mean Nomogram Residues
Maximum Nomogram Residues
Toxicity
Off-field
Off-field
(mg
On-field
(3%
drift)
On-field
(3%
drift)
Exposure
Food Guild (Food Item)
a.e./kg
EDE (mg RQ EDE (mg RQ EDE (mg RQ EDE (mg RQ
bw/d)
a.e./kg bw)
a.e./kg
a.e./kg bw)
a.e./kg
bw)
bw)
>319.63
Frugivore (fruit)
41.82
< 0.1
1.25
< 0.004 19.94
< 0.1
0.6
< 0.002
> 319.63
Herbivore (short grass)
298.91
< 0.9
8.97
< 0.03 106.16
< 0.3
3.18
< 0.01
> 319.63
Herbivore (long grass)
182.51
< 0.6
5.48
< 0.02
59.6
< 0.2
1.79
< 0.01
> 319.63 Herbivore (Broadleaf plants) 276.56
< 0.9
8.3
< 0.03
91.42
< 0.3
2.74
< 0.01
> 258.00
Insectivore
135.1
< 0.5
4.05
< 0.02
93.29
< 0.4
2.8
< 0.01
> 258.00 Granivore (grain and seeds) 20.91
< 0.1
0.63
< 0.002 93.29
< 0.4
0.3
< 0.001
> 258.00
Frugivore (fruit)
41.82
< 0.2
1.25
< 0.005 19.94
< 0.1
0.6
< 0.002
Dietary
> 258.00
Herbivore (short grass)
298.91
8.97
< 0.03 106.16
< 0.4
3.18
< 0.01
< 1.2
> 258.00
Herbivore (long grass)
182.51
< 0.7
5.48
< 0.02
59.6
< 0.2
1.79
< 0.01
> 258.00 Herbivore (Broadleaf plants) 276.56
8.3
< 0.03
91.42
< 0.4
2.74
< 0.01
< 1.1
291
Insectivore
135.1
0.5
4.05
0.01
93.29
0.3
2.8
0.01
291
Granivore (grain and seeds) 20.91
0.1
0.63
0.002
93.29
0.3
0.3
0.001
291
Frugivore (fruit)
41.82
0.1
1.25
0.004
19.94
0.1
0.6
0.002
Reproduction
291
Herbivore (short grass)
298.91
8.97
0.03
106.16
0.4
3.18
0.01
1.0
291
Herbivore (long grass)
182.51
0.6
5.48
0.02
59.6
0.2
1.79
0.01
291
Herbivore (Broadleaf plants) 276.56
1.0
8.3
0.03
91.42
0.3
2.74
0.01
Shaded cells and bold values indicate that the level of concern is exceeded (RQ > 1).

Proposed Re-evaluation Decision – PRVD2015-01
Page 211

 Appendix X

Table X.22

Screening Level Risk Assessment for Glyphosate Formulations Exposed to Wild Birds and Mammals – Single
Application Rate

Exposure

Toxicity (mg a.e/kg
bw/d)

Feeding Guild (Food Item)

Small Bird (0.02 kg)
Acute
113.1
Insectivore
Reproduction
n/a
Insectivore
Medium-Sized Bird (0.1 kg)
Acute
113.1
Insectivore
Reproduction
n/a
Insectivore
Large-Sized Bird (1 kg)
Acute
113.1
Herbivore (short grass)
Reproduction
n/a
Herbivore (short grass)
Small Mammal (0.015 kg)
Acute
35.7
Insectivore
Reproduction
n/a
Insectivore
Medium-Sized Mammal (0.035 kg)
Acute
35.7
Herbivore (short grass)
Reproduction
n/a
Herbivore (short grass)
Large-Sized Mammal (1 kg)
Acute
35.7
Herbivore (short grass)
Reproduction
n/a
Herbivore (short grass)
Shaded cells and bold values indicate that the level of concern is exceeded (RQ > 1).

Proposed Re-evaluation Decision – PRVD2015-01
Page 212

EDE (mg a.e/kg bw)

RQ

351.63
351.63

3.1
n/a

274.41
274.41

2.4
n/a

177.25
177.25

1.6
n/a

202.25
202.25

5.7
n/a

392.25
392.25

11
n/a

209.59
209.59

5.9
n/a

 Appendix X

Table X.23

Toxicity
(mg
a.e./kg
bw/d)

Further Characterization of Risks of Glyphosate Formulations to Wild Birds – Single Application Rate
Maximum Nomogram Residues
Off-field
On-field
(3%
EDE (mg
drift)
RQ
RQ
a.e./kg
EDE (mg
bw)
a.e./kg
bw)

Food Guild (food item)

Small Bird (0.02 kg)
113.1
Insectivore
Acute
113.1
Granivore (grain and seeds)
113.1
Frugivore (fruit)
> 18.70
Insectivore
Dietary > 18.70 Granivore (grain and seeds)
> 18.70
Frugivore (fruit)
Medium-Sized Bird (0.1 kg)
113.1
Insectivore
Acute
113.1
Granivore (grain and seeds)
113.1
Frugivore (fruit)
> 18.70
Insectivore
Dietary > 18.70 Granivore (grain and seeds)
> 18.70
Frugivore (fruit)
Large-Sized Bird (1 kg)
113.1
Insectivore
113.1
Granivore (grain and seeds)
113.1
Frugivore (fruit)
Acute
113.1
Herbivore (short grass)
113.1
Herbivore (long grass)
113.1 Herbivore (Broadleaf plants)
> 18.70
Insectivore
Dietary
> 18.70 Granivore (grain and seeds)

Mean Nomogram Residues
Off-field
On-field
(3%
EDE (mg
drift)
RQ
RQ
a.e./kg
EDE (mg
bw)
a.e./kg
bw)

351.63
54.42
108.84
351.63
54.42
108.84

3.1
0.5
0.96
< 18.8
< 2.9
< 5.8

10.55
1.63
3.27
10.55
1.63
3.27

0.09
0.01
0.03
< 0.6
< 0.09
< 0.2

242.79
25.95
51.91
242.79
25.95
51.91

2.2
0.23
0.46
< 13.0
< 1.4
< 2.8

7.28
0.78
1.56
7.28
0.78
1.56

0.06
0.01
0.01
< 0.4
< 0.04
< 0.08

274.41
42.47
84.94
274.41
42.47
84.94

2.4
0.4
0.8
<14.7
< 2.3
< 4.5

8.23
1.27
2.55
8.23
1.27
2.55

0.07
0.01
0.02
< 0.4
< 0.07
< 0.1

189.47
20.25
40.51
189.47
20.25
40.51

1.7
0.18
0.36
< 10.1
< 1.1
< 2.2

5.68
0.61
1.22
5.68
0.61
1.22

0.05
0.01
0.01
< 0.30
< 0.03
< 0.06

80.12
12.4
24.8
177.25
108.23
164
80.12
12.4

0.7
0.1
0.2
1.6
0.96
1.5
< 4.3
< 0.7

2.4
0.37
0.74
5.32
3.25
4.92
2.4
0.37

0.02
0.003
0.01
0.05
0.03
0.04
< 0.1
< 0.02

55.32
55.32
11.83
62.95
35.34
54.21
55.32
55.32

0.5
0.5
0.1
0.6
0.3
0.5
< 3.0
<3.0

1.66
0.18
0.35
1.89
1.06
1.63
1.66
0.18

0.01
0.002
0.003
0.02
0.01
0.01
< 0.09
< 0.01

Proposed Re-evaluation Decision – PRVD2015-01
Page 213

 Appendix X

Toxicity
(mg
a.e./kg
bw/d)
> 18.70
> 18.70
> 18.70
> 18.70

Maximum Nomogram Residues
Off-field
On-field
(3%
EDE (mg
drift)
Food Guild (food item)
RQ
RQ
a.e./kg
EDE (mg
bw)
a.e./kg
bw)
Frugivore (fruit)
24.8
0.74
< 0.04
< 1.3
Herbivore (short grass)
177.25
5.32
< 0.3
< 9.5
Herbivore (long grass)
108.23
3.25
< 0.2
< 5.8
Herbivore (Broadleaf plants)
164
4.92
< 0.3
< 8.8

Mean Nomogram Residues
Off-field
On-field
(3%
EDE (mg
drift)
RQ
RQ
a.e./kg
EDE (mg
bw)
a.e./kg
bw)
11.83
< 0.6
0.35
< 0.02
62.95
1.89
< 0.1
< 3.4
35.34
1.06
< 0.06
< 1.9
54.21
1.63
< 0.09
< 2.9

Shaded cells and bold values indicate that the level of concern is exceeded (RQ > 1).
Table X.24

Toxicity
(mg
a.e./kg
bw/d)

Further Characterization of the Risk of Glyphosate Technical to Wild Mammals
Maximum Nomogram Residues
Off-field
On-field
(3%
EDE (mg
drift)
RQ
RQ
a.e./kg
EDE (mg
bw)
a.e./kg
bw)

Food Guild (Food Item)

Small Mammal (0.015 kg)
Acute –
156.8
Insectivore
most
156.8
Granivore (grain and seeds)
sensitive
156.8
Frugivore (fruit)
endpoint
Acute –
560
Insectivore
least
560
Granivore (grain and seeds)
sensitive
560
Frugivore (fruit)
endpoint
Medium-Sized Mammal (0.035 kg)
156.8
Insectivore
Acute –
156.8
Granivore (grain and seeds)
most
sensitive
156.8
Frugivore (fruit)
endpoint
156.8
Herbivore (short grass)

Mean Nomogram Residues
Off-field
On-field
(3%
EDE (mg
drift)
RQ
RQ
a.e./kg
EDE (mg
bw)
a.e./kg
bw)

341.06
52.78
105.57

2.2
0.3
0.7

10.23
1.58
3.17

0.07
0.01
0.02

235.49
25.17
50.35

1.5
0.2
0.3

7.06
0.76
1.51

0.05
0.007
0.01

341.06

0.6

10.23

0.02

235.49

0.4

7.06

0.01

52.78
105.57

0.09
0.2

1.58
3.17

0.003
0.01

25.17
50.35

0.04
0.09

0.76
1.51

0.001
0.003

298.98
46.27
92.54
661.47

1.9
0.3
0.6
4.2

8.97
1.39
2.78
19.84

0.06
0.009
0.02
0.1

206.44
22.07
44.13
234.92

1.3
0.1
0.3
1.5

6.19
0.66
1.32
7.05

0.04
0.004
0.008
0.04

Proposed Re-evaluation Decision – PRVD2015-01
Page 214

 Appendix X

Maximum Nomogram Residues
Off-field
Toxicity
On-field
(3%
(mg
EDE (mg
drift)
Food Guild (Food Item)
RQ
RQ
a.e./kg
a.e./kg
EDE (mg
bw/d)
bw)
a.e./kg
bw)
156.8
Herbivore (long grass)
403.88
12.12
0.08
2.6
156.8
Herbivore (broadleaf plants) 612.01
18.36
0.1
3.9
560
Insectivore
298.98
0.5
8.97
0.02
560
Granivore (grain and seeds)
46.27
0.08
1.39
0.002
Acute –
560
Frugivore (fruit)
92.54
0.2
2.78
0.005
least
sensitive
560
Herbivore (short grass)
661.47
19.84
0.04
1.2
endpoint
560
Herbivore (long grass)
403.88
0.7
12.12
0.02
560
Herbivore (broadleaf plants) 612.01
18.36
0.03
1.1
Large-Sized Mammal (1 kg)
156.8
Insectivore
159.75
4.79
0.03
1
156.8
Granivore (grain and seeds)
24.72
0.2
0.74
0.005
Acute –
156.8
Frugivore (fruit)
49.45
0.3
1.48
0.01
most
sensitive
156.8
Herbivore (short grass)
353.45
10.6
0.07
2.3
endpoint
156.8
Herbivore (long grass)
215.81
6.47
0.04
1.4
156.8
Herbivore (broadleaf plants) 327.01
9.81
0.06
2.1
560
Insectivore
159.75
0.3
4.79
0.01
560
Granivore (grain and seeds)
24.72
0.04
0.74
0.001
Acute –
560
Frugivore (fruit)
49.45
0.09
1.48
0.003
least
sensitive
560
Herbivore (short grass)
353.45
0.6
10.6
0.02
endpoint
560
Herbivore (long grass)
215.81
0.4
6.47
0.01
560
Herbivore (broadleaf plants) 327.01
0.6
9.81
0.02

Shaded cells and bold values indicate that the level of concern is exceeded (RQ > 1).

Proposed Re-evaluation Decision – PRVD2015-01
Page 215

Mean Nomogram Residues
Off-field
On-field
(3%
EDE (mg
drift)
RQ
RQ
a.e./kg
EDE (mg
bw)
a.e./kg
bw)
131.88
0.8
3.96
0.03
202.32
6.07
0.04
1.3
206.44
0.4
6.19
0.01
22.07
0.04
0.66
0.001
44.13
0.08
1.32
0.002
234.92
0.4
7.05
0.01
131.88
0.2
3.96
0.01
202.32
0.4
6.07
0.01
110.31
11.79
23.58
125.52
70.47
108.1
110.31
11.79
23.58
125.52
70.47
108.1

0.7
0.08
0.2
0.8
0.4
0.7
0.2
0.02
0.04
0.2
0.1
0.2

3.31
0.35
0.71
3.77
2.11
3.24
3.31
0.35
0.71
3.77
2.11
3.24

0.02
0.002
0.005
0.02
0.01
0.02
0.01
0.001
0.001
0.01
0.004
0.01

 Appendix X

Table X.25

Further Characterization of Risks of Glyphosate Formulations to Wild Mammals – Single Application Rate

Toxicity
(mg
a.e./kg
bw/d)

Maximum Nomogram Residues
Off-field
On-field
(3%
EDE (mg
drift)
RQ
RQ
a.e./kg
EDE (mg
bw)
a.e./kg
bw)

Food Guild (Food Item)

Small Mammal (0.015 kg)
Acute –
35.7
Insectivore
most
35.7
Granivore (grain and seeds)
sensitive
35.7
Frugivore (fruit)
endpoint
Acute – > 400.00
Insectivore
least
sensitive > 400.00 Granivore (grain and seeds)
Frugivore (fruit)
endpoint > 400.00
Medium-Sized Mammal (0.035 kg)
35.7
Insectivore
35.7
Granivore (grain and seeds)
Acute –
35.7
Frugivore (fruit)
most
sensitive
35.7
Herbivore (short grass)
endpoint
35.7
Herbivore (long grass)
35.7
Herbivore (broadleaf plants)
> 400.00
Insectivore
Acute – > 400.00 Granivore (grain and seeds)
> 400.00
Frugivore (fruit)
least
sensitive > 400.00
Herbivore (short grass)
endpoint > 400.00
Herbivore (long grass)
> 400.00 Herbivore (broadleaf plants)

Mean Nomogram Residues
Off-field
On-field
(3%
EDE (mg
drift)
RQ
RQ
a.e./kg
EDE (mg
bw)
a.e./kg
bw)

202.25

5.7

6.07

0.2

139.65

3.9

4.19

0.1

31.3
62.6

0.9
1.7

0.94
1.88

0.03
0.05

14.93
29.86

0.4
0.8

0.45
0.9

0.01
0.03

202.25

< 0.5

6.07

< 0.02

139.65

< 0.35

4.19

< 0.01

31.3
62.6

< 0.08
< 0.2

0.94
1.88

< 0.002
< 0.005

14.93
29.86

< 0.04
< 0.07

0.45
0.9

< 0.001
< 0.002

177.29
27.44
54.88
392.25
239.5
362.92
177.29
27.44
54.88
392.25
239.5
362.92

5
0.8
1.5
11
6.7
10.2
< 0.4
< 0.07
< 0.1
<0.98
< 0.6
< 0.9

5.32
0.82
1.65
11.77
7.19
10.89
5.32
0.82
1.65
11.77
7.19
10.89

0.1
0.02
0.05
0.3
0.2
0.3
< 0.01
< 0.002
< 0.004
< 0.03
<0.02
<0.03

122.42
13.09
26.17
139.3
78.2
119.97
122.42
13.09
26.17
139.3
78.2
119.97

3.4
0.4
0.7
3.9
2.2
3.4
< 0.3
< 0.03
< 0.07
< 0.4
< 0.2
< 0.3

3.67
0.39
0.79
4.18
2.35
3.6
3.67
0.39
0.79
4.18
2.35
3.6

0.1
0.01
0.02
0.1
0.07
0.1
< 0.01
< 0.001
< 0.002
< 0.01
< 0.01
< 0.01

Proposed Re-evaluation Decision – PRVD2015-01
Page 216

 Appendix X

Toxicity
(mg
a.e./kg
bw/d)

Maximum Nomogram Residues
Off-field
On-field
(3%
EDE (mg
drift)
RQ
RQ
a.e./kg
EDE (mg
bw)
a.e./kg
bw)

Food Guild (Food Item)

Large-Sized Mammal (1 kg)
35.7
Insectivore
35.7
Granivore (grain and seeds)
Acute –
35.7
Frugivore (fruit)
most
sensitive
35.7
Herbivore (short grass)
endpoint
35.7
Herbivore (long grass)
35.7
Herbivore (broadleaf plants)
> 400.00
Insectivore
Acute – > 400.00 Granivore (grain and seeds)
> 400.00
Frugivore (fruit)
least
sensitive > 400.00
Herbivore (short grass)
endpoint > 400.00
Herbivore (long grass)
> 400.00 Herbivore (broadleaf plants)

94.73
14.66
29.32
209.59
127.97
193.92
94.73
14.66
29.32
209.59
127.97
193.92

2.6
0.4
0.8
5.9
3.6
5.4
< 0.2
< 0.04
< 0.07
< 0.5
< 0.3
< 0.5

2.84
0.44
0.88
6.29
3.84
5.82
2.84
0.44
0.88
6.29
3.84
5.82

0.08
0.01
0.02
0.2
0.1
0.2
< 0.01
< 0.001
< 0.002
< 0.02
< 0.01
< 0.01

1

Mean Nomogram Residues
Off-field
On-field
(3%
EDE (mg
drift)
RQ
RQ
a.e./kg
EDE (mg
bw)
a.e./kg
bw)
65.41
6.99
13.98
74.44
41.79
64.11
65.41
6.99
13.98
74.44
41.79
64.11

1.8
0.2
0.4
2.1
1.2
1.8
< 0.2
< 0.02
< 0.03
< 0.2
< 0.1
< 0.2

1.96
0.21
0.42
2.23
1.25
1.92
1.96
0.21
0.42
2.23
1.25
1.92

0.06
0.006
0.01
0.06
0.04
0.05
< 0.005
< 0.001
< 0.001
< 0.01
< 0.003
< 0.005

EDE = Estimated dietary exposure; is calculated using the following formula: (FIR/BW) × EEC, where: FIR: Food Ingestion Rate (Nagy, 1987). For mammals,
the “all mammals” equation was used: FIR (g dry weight/day) = 0.235(BW in g) 0.822.
BW: Generic Body Weight ; EEC: Concentration of pesticide on food item based on Hoerger and Kenaga (1972) and Kenaga (1973) and modified according to
Fletcher et al. (1994). At the screening level, relevant food items representing the most conservative EEC are used.
Shaded cells and bold values indicate that the level of concern is exceeded (RQ > 1).

Proposed Re-evaluation Decision – PRVD2015-01
Page 217

 Appendix X

Table X.26

Organism

Risk Assessment (In-field and Off-field) and Risk Quotients for Terrestrial Vascular Plants (Seedling
Emergence and Vegetative Vigour) at the Maximum Rate of Application for Glyphosate in Different Crop
Productions
Exposure

Endpoint Value

Crop
Apple

Canola
Seedling
emergence

EC50: 3.25 kg a.e./ha
Corn

Potato
Apple

Vascular
Plants

Vegetative
vigour –
formulations
without POEA

Canola
EC50 value:
0.014 kg a.e./ha
Corn

Potato
Vegetative
vigour –
formulations

HC5 of SSD for 2 × EC25
values:
0.069 kg a.e./ha

Apple

EEC
In-field: 9.55 kg a.e./ha
Off-field (ground application, 3% drift): 0.287 kg
a.e./ha
In-field: 7.812 kg a.e./ha
Off-field (ground application, 3% drift): 0.234 kg
a.e./ha
Off-field (aerial application, 17% drift): 1.328 kg
a.e./ha
In-field: 7.528 kg a.e./ha
Off-field (ground application, 3% drift): 0.226 kg
a.e./ha
In-field: 4.32 kg a.e./ha
Off-field (ground application, 3% drift): 0.13 kg
a.e./ha
In-field: 7.285 kg a.e./ha
Off-field (ground application, 3% drift): 0.219 kg
a.e./ha
In-field: 6.99 kg a.e./ha
Off-field (ground application, 3% drift): 0.21 kg
a.e./ha
Off-field (aerial application, 17% drift): 1.19 kg
a.e./ha
In-field: 6.522 kg a.e./ha
Off-field (ground application, 3% drift): 0.196 kg
a.e./ha
In-field: 4.32 kg a.e./ha
Off-field (ground application, 3% drift): 0.13 kg
a.e./ha
In-field: 7.285 kg a.e./ha
Off-field (ground application, 3% drift): 0.219 kg
a.e./ha

Proposed Re-evaluation Decision – PRVD2015-01
Page 218

RQ1
2.9
0.09
2.4
0.07
0.4
2.3
0.07
1.3
0.04
520.4
15.6
499.3
15.0
85.0
465.9
14.0
308.6
9.3
105.6
3.2

 Appendix X

Organism

Exposure

Endpoint Value

Crop

with POEA
Canola

Corn

Potato
1

RQ1

EEC
In-field: 6.99 kg a.e./ha
Off-field (ground application, 3% drift): 0.21 kg
a.e./ha
Off-field (aerial application, 17% drift): 1.19 kg
a.e./ha
In-field: 6.522 kg a.e./ha
Off-field (ground application, 3% drift): 0.196 kg
a.e./ha
In-field: 4.32 kg a.e./ha
Off-field (ground application, 3% drift): 0.13 kg
a.e./ha

101.3
3.0
17.2
94.5
2.8
62.6
1.9

Shaded cells and bold values indicate that the level of concern is exceeded (RQ > 1).

Table X.27

Test Material

Screening Level Risk Assessment of Glyphosate Technical, Glyphoate Formulations, the Transformation
Product AMPA and the Formulant POEA to Aquatic Organisms Following Ground Boom Application in
Different Crop Productions
Exposure

Freshwater Invertebrates
Technical
Acute
grade active
Chronic
ingredient
Acute
EUP NonPOEA
Chronic
Acute

Endpoint Value
(mg a.e./L)

Application Rate/Interval

EEC
(mg
a.e./L)

HC5: 16.9
NOEC: 7.14

HC5: 0.19

Apple

Apple
Potato

Chronic

NOEC: 0.27

Acute

HC5: 0.0041

RQ1

0.09

HC5: 30.5
½ EC50: 21.9

EUP With
POEA

POEA

Crop

Depth
(cm)

Apple
Potato
Apple

0.2

4320 g a.e./ha × 2 + 3960 g a.e./ha
at 14 d
4320 g a.e./ha × 2 + 3960 g a.e./ha
at 14 d
4320 g a.e./ha
4320 g a.e./ha × 2 + 3960 g a.e./ha
at 14 d
4320 g a.e./ha
1967 g a.e./ha × 2 + 1803 g a.e./ha

Proposed Re-evaluation Decision – PRVD2015-01
Page 219

1.5
80

0.05
0.07
7.9

0.5

2.6

1.5

5.6

0.5
0.51

1.9
124

 Appendix X

Test Material

Exposure

Endpoint Value
(mg a.e./L)

Crop

mg/L
Potato

AMPA
Snails
Technical
grade active
ingredient
EUP NonPOEA
EUP With
POEA
Freshwater Fish
Technical
grade active
ingredient
EUP NonPOEA

Chronic

½ EC50: 0.85
mg/L

Acute

½ EC50: 204
mg/L

Chronic

NOEC: 1000

Apple
Potato
Apple

Apple
Chronic
Acute

Depth
(cm)

at 14 d
1967 g a.e./ha
1967 g a.e./ha × 2 + 1803 g a.e./ha
at 14 d
1967 g a.e./ha
2837 g a.e./ha × 2 + 2600 g a.e./ha
at 14 d

½ LC50: 1.15

Apple
Potato

Chronic

NOEC: 8.6

Apple

Acute

HC5: 80.4

Apple

Chronic

NOEC: 25.7

Apple

1/10 LC50: 12.2

Apple

Acute

HC5: 1.74

Chronic

NOEC: 0.36

Apple
Apple
Potato

POEA

Acute

HC5: 0.26

Apple

AMPA

Acute

1/10 LC50: 29.7

Apple

4320 g a.e./ha × 2 + 3960 g a.e./ha
at 14 d
4320 g a.e./ha
4320 g a.e./ha × 2 + 3960 g a.e./ha
at 14 d

EEC
(mg
a.e./L)

RQ1

0.25

61

0.51

0.6

0.25

0.29

0.9

0.004

0.01

4320 g a.e./ha × 2 + 3960 g a.e./ha
at 14 d

8.2

NOEC: 29.6

Acute

EUP With
POEA

Application Rate/Interval

0.28

15
7.1
2.88

2.5

8.2

0.95
0.02
0.06

4320 g a.e./ha × 2 + 3960 g a.e./ha
at 14 d

1.5

0.5

0.86
4.2
1.4

0.51

2

0.9

0.03

80
4320 g a.e./ha
1967 g a.e./ha × 2 + 1803 g a.e./ha
at 14 d
2837 g a.e./ha × 2 + 2600 g a.e./ha
at 14 d

Proposed Re-evaluation Decision – PRVD2015-01
Page 220

0.12

 Appendix X

Test Material
Freshwater Algae
Technical
grade active
ingredient
EUP NonPOEA

EUP With
POEA

Exposure

Endpoint Value
(mg a.e./L)

Acute

HC5: 6.6

Chronic

HC5: 118

Acute

½ EC50: 0.06

Crop

Application Rate/Interval

Apple

4320 g a.e./ha × 2 + 3960 g a.e./ha
at 14 d

Apple
Potato

Acute

½ EC50: 4.6

Chronic

HC5: 0.42

Apple
Apple
Potato

POEA
ALONE

Acute

½ EC50: 1.7

Apple

AMPA

Acute

½ EC50: 71.5

Apple

Acute

½ EC50: 10.6

Apple

Acute

½ EC50: 3.85

Apple

Acute

HC5: 0.003

Freshwater Plants
Technical
grade active
ingredient
EUP NonPOEA
EUP With
POEA

Apple
Potato

4320 g a.e./ha × 2 + 3960 g a.e./ha
at 14 d
4320 g a.e./ha
4320 g a.e./ha × 2 + 3960 g a.e./ha
at 14 d
4320 g a.e./ha × 2 + 3960 g a.e./ha
at 14 d
4320 g a.e./ha
1967 g a.e./ha × 2 + 1803 g a.e./ha
at 14 d
2837 g a.e./ha × 2 + 2600 g a.e./ha
at 14 d

Depth
(cm)

RQ1

0.23
1.5

80

4320 g a.e./ha × 2 + 3960 g a.e./ha
at 14 d
4320 g a.e./ha × 2 + 3960 g a.e./ha
at 14 d
4320 g a.e./ha × 2 + 3960 g a.e./ha
at 14 d
4320 g a.e./ha

EEC
(mg
a.e./L)

80

0.01

1.5

25

0.5

8.3

1.5

0.32

1.5

3.6

0.5

1.2

0.51

0.3

0.9

0.01

1.5

0.14

1.5

0.39

1.5

500

0.5

167

8.2

0.55

8.2

4.6

2.9

1.6

Amphibians Lab Data
Technical
grade active
ingredient

Acute
Chronic

HC5: 15
42-d NOEC: 1.8

Apple
Apple
Potato

4320 g a.e./ha × 2 + 3960 g a.e./ha
at 14 d
4320 g a.e./ha × 2 + 3960 g a.e./ha
at 14 d
4320 g a.e./ha

Proposed Re-evaluation Decision – PRVD2015-01
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15

 Appendix X

Test Material
EUP NonPOEA

Exposure

Endpoint Value
(mg a.e./L)

Crop

Acute

HC5: 18

Apple

Acute

HC5: 0.93

Apple
Potato

EUP With
POEA
Chronic

HC5: 0.86

Apple
Potato

Application Rate/Interval

Depth
(cm)

4320 g a.e./ha × 2 + 3960 g a.e./ha
at 14 d
4320 g a.e./ha × 2 + 3960 g a.e./ha
at 14 d
4320 g a.e./ha
4320 g a.e./ha × 2 + 3960 g a.e./ha
at 14 d
4320 g a.e./ha

EEC
(mg
a.e./L)

RQ1

8.2

0.46

8.2

8.8

2.9

3.1

8.2

9.5

2.9

3.4

8.2

3.6

2.9

1.3

8.2

6.0

2.9

2.1

1.5

5

0.5

1.7

1.5

0.13

1.5

150

0.5

50

0.51

1.7

0.25

0.83

0.9

< 0.02

Amphibian Field Mesocosm Data
Acute

HC5: 2.29

Apple
Potato

EUP With
POEA
Chronic

HC5 : 1.36

Apple
Potato

Marine/Estuarine Invertebrates
Technical
grade active
Acute
ingredient
EUP NonAcute
POEA
EUP With
POEA

Acute

POEA

Acute

HC5: 0.3

Apple
Potato

½ EC50: 11.6
HC5: 0.01

Apple
Apple
Potato

½ EC50: 0.3

Apple
Potato

AMPA

Acute

½ EC50: > 48.5

Apple

4320 g a.e./ha × 2 + 3960 g a.e./ha
at 14 d
4320 g a.e./ha
4320 g a.e./ha × 2 + 3960 g a.e./ha
at 14 d
4320 g a.e./ha
4320 g a.e./ha × 2 + 3960 g a.e./ha
at 14 d
4320 g a.e./ha
4320 g a.e./ha × 2 + 3960 g a.e./ha
at 14 d
4320 g a.e./ha × 2 + 3960 g a.e./ha
at 14 d
4320 g a.e./ha
1967 g a.e./ha × 2 + 1803 g a.e./ha
at 14 d
1967 g a.e./ha
2837 g a.e./ha × 2 + 2600 g a.e./ha
at 14 d

Proposed Re-evaluation Decision – PRVD2015-01
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15

80

 Appendix X

Test Material

Endpoint Value
(mg a.e./L)

Crop

Acute

HC5: 23

Apple

Chronic

NOEC: 0.1

Exposure

Application Rate/Interval

Depth
(cm)

EEC
(mg
a.e./L)

RQ1

1.5

0.06

1.5

15

0.5

5

1.5

0.11

1.5

0.5

0.5

0.17

0.51

0.24

0.25

0.12

1.5

0.94

1.5

0.05

1.5

0.88

1.5

4.4

0.5

2.9

0.51

0.55

Marine/Estuarine Fish
Technical
grade active
ingredient

Apple
Potato

EUP NonPOEA

Acute

1/10 LC50: 14

EUP With
POEA

Acute

HC5: 3.0

POEA

Acute

Apple
Apple
Potato

HC5: 2.1

Apple
Potato

4320 g a.e./ha × 2 + 3960 g a.e./ha
at 14 d
4320 g a.e./ha × 2 + 3960 g a.e./ha
at 14 d
4320 g a.e./ha
4320 g a.e./ha × 2 + 3960 g a.e./ha
at 14 d
4320 g a.e./ha × 2 + 3960 g a.e./ha
at 14 d
4320 g a.e./ha
1967 g a.e./ha × 2 + 1803 g a.e./ha
at 14 d
1967 g a.e./ha

80

Marine/Estuarine Algae
4320 g a.e./ha × 2 + 3960 g a.e./ha
at 14 d
4320 g a.e./ha × 2 + 3960 g a.e./ha
Chronic
HC5: 28.4
Apple
at 14 d
4320 g a.e./ha × 2 + 3960 g a.e./ha
Acute
½ EC50: 1.7
Apple
at 14 d
EUP With
4320 g a.e./ha × 2 + 3960 g a.e./ha
Apple
POEA
at 14 d
Chronic
HC5: 0.33
Potato
4320 g a.e./ha
1967 g a.e./ha × 2 + 1803 g a.e./ha
POEA
Acute
½ EC50: 0.93
Apple
at 14 d
1
Shaded cells and bold values indicate that the level of concern is exceeded (RQ > 1).
Technical
grade active
ingredient

Acute

½ EC50: 1.6

Apple

Refined Risk Assessment on Non-Target Aquatic Species

Proposed Re-evaluation Decision – PRVD2015-01
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80

 Appendix X

Table X.28

Further Risk Characterization of Glyphosate Technical, Glyphosate Formulations, Transformation Product
AMPA and the Formulant POEA Exposed to Aquatic Organisms Following Drift from Ground Boom or Aerial
Applications in Different Crop Productions

Test Material

Exposure

Endpoint
Value
(mg ae/L)

Acute

HC5: 0.19

Chronic

NOEC :0.27

Use Scenario

Application Rate
(g ae/ha)

EEC
(mg a.e/L)

RQ

LOC
Exceeded

Aerial (canola)
Ground (potato)
Aerial (canola)
Ground (potato)
Aerial (canola)
Ground (potato)

4320 + 4320 + 902 at 10 d
4320
4320 + 4320 + 902 at 10 d
4320
1967 + 1967 + 411 at 10 d
1967

0.2
0.02
0.2
0.02
0.066
0.0075

1.1
0.11
0.74
0.07
16.1
1.8

Yes
No
No
No
Yes
Yes

Aerial (canola)
Ground (potato)

4320 + 4320 + 902 at 10 d
4320

1.06
0.09

0.92
0.08

No
No

Aerial (canola)
Ground (potato)
Aerial (canola)

4320 + 4320 + 902 at 10 d
4320
1967 + 1967 + 411 at 10 d

0.2
0.02
0.066

0.56
0.06
0.25

No
No
No

Aerial (canola)
Ground (potato)
Aerial (canola)
Ground (potato)
Aerial (canola)
Ground (potato)

4320 + 4320 + 902 at 10 d
4320
4320 + 4320 + 902 at 10 d
4320
4320 + 4320 + 902 at 10 d
4320

1.06
0.09
1.06
0.09
1.06
0.09

0.59
0.05
1.1
0.1
1.2
0.1

No
No
Yes
No
Yes
No

Aerial (canola)

4320 + 4320 + 902 at 10 d

1.06

0.5

No

Ground (potato)
Aerial (canola)
Ground (potato)

4320
4320 + 4320 + 902 at 10 d
4320

0.09
1.06
0.09

0.04
0.8
0.07

No
No
No

Freshwater Invertebrates
EUP With POEA

POEA

Acute

HC5: 0.0041

Acute

½ LC50: 1.15

Chronic

NOEC :0.36

Acute

HC5: 0.26

Chronic

NOEC: 1.8

Acute

HC5: 0.93

Chronic

HC5: 0.86

Acute

HC5: 2.29

Chronic

HC5: 1.36

Freshwater Snails
EUP With POEA
Freshwater Fish
EUP With POEA
POEA
Amphibian Laboratory Data
Technical grade active ingredient

EUP With POEA

Amphibian Field Mesocosm Data
EUP With POEA

Proposed Re-evaluation Decision – PRVD2015-01
Page 224

 Appendix X

Test Material

Exposure

Endpoint
Value
(mg ae/L)

Acute

½ EC50: 0.06

Use Scenario

Application Rate
(g ae/ha)

EEC
(mg a.e/L)

RQ

LOC
Exceeded

Aerial (canola)

4320 + 4320 + 902 at 10 d

0.2
0.02
0.2
0.02

3.3
0.33
0.48
0.05

Yes
No
No
No

Ground (potato)
Aerial (canola)
Ground (potato)

4320
4320 + 4320 + 902 at 10 d
4320

Aerial (canola)
Ground (potato)

4320 + 4320 + 902 at 10 d
4320

0.2
0.02

67
6.7

Yes
Yes

Aerial (canola)
Ground (potato)
Aerial (canola)
Ground (potato)

4320 + 4320 + 902 at 10 d
4320
4320 + 4320 + 902 at 10 d
4320

0.2
0.02
0.2
0.02

0.67
0.07
20
2

No
No
Yes
Yes

Freshwater Algae
EUP Non-POEA
EUP With POEA

Chronic

HC5: 0.42

Acute

HC5:0.003

Technical grade active ingredient

Acute

HC5: 0.3

EUP With POEA

Acute

HC5: 0.01

POEA

Acute

½ EC50: 0.3

Aerial (canola)
Ground (potato)

1967 + 1967 + 411 at 10 d
1967

0.066
0.008

0.22
0.03

No
No

Chronic

NOEC: 0.1

Aerial (canola)
Ground (potato)

4320 + 4320 + 902 at 10 d
4320

0.2
0.02

2
0.2

Yes
No

Aerial (canola)
4320 + 4320 + 902 at 10 d
Ground (potato)
4320
Shaded cells and bold values indicate that the level of concern is exceeded (RQ > 1).

0.2
0.02

0.6
0.12

No
No

Freshwater Plants
EUP With POEA
Marine/Estuarine Invertebrates

Marine/Estuarine Fish
Technical grade active ingredient
Marine/Estuarine Algae
EUP With POEA

Chronic

HC5: 0.33

Proposed Re-evaluation Decision – PRVD2015-01
Page 225

 Appendix X

Table X.29

Further Risk Characterization of Glyphosate Technical and Glyphosate Formulations Exposed to Aquatic
Organisms Following Runoff in Different Crop Productions

Test Material

Exposure

Endpoint Value
(mg ag/L)

Crop-Region
(Use Rate g a.e./ha, Application
Interval)

EEC
(mg a.e./L)

RQ

LOC
Exceeded

Acute
Chronic

HC5: 0.19
NOEC: 0.27

Potato – PEI (4320)

0.096
0.078

0.51
0.29

No
No

Acute

½ EC50: 1.15

Potato – PEI (4320)

0.096

0.08

No

Chronic

NOEC: 0.36

Potato – PEI (4320)
Apple – BC (2 × 4320 +3960, 14 d)

0.091
0.003

0.25
0.01

No
No

Potato – PEI (4320)
Apple – BC (2 × 4320 +3960, 14 d)
Potato- PEI (4320)
Apple – BC (2 × 4320 +3960, 14 d)

0.159
0.006
0.102
0.002

0.17
0.01
0.12
< 0.01

No
No
No
No

Potato – PEI (4320)

0.102

0.08

No

Potato – PEI (4320)
Apple – BC (2 × 4320 +3960, 14 d)
Potato – PEI (4320)

0.096
0.003
0.078

1.6
0.05
0.19

Yes
No
No

HC5: 0.003

Potato – PEI (4320)
Apple – BC (2 × 4320 +3960, 14 d)

0.078
0.002

26
0.67

Yes
No

HC5: 0.01

Potato – PEI (4320)
Apple – BC (2 × 4320 +3960, 14 d)

0.096
0.003

9.6
0.3

Yes
No

NOEC: 0.1

Potato – PEI (4320)

0.078

0.78

No

Freshwater Organisms
Freshwater Invertebrates
EUP With POEA
Freshwater Snails
EUP With POEA
Freshwater Fish
EUP With POEA
Freshwater Amphibians
Laboratory Data

EUP With POEA

Acute

HC5: 0.93

Chronic

HC5: 0.86

Field Mesocosm Data
Chronic
HC5: 1.36
Freshwater Algae
EUP Non-POEA

Acute

HC5: 0.06

EUP With POEA
Freshwater Plants

Chronic

HC5: 0.42

EUP With POEA

Acute

Marine/Estuarine Organisms
Marine/Estuarine Invertebrates
EUP With POEA

Acute

Marine/Estuarine Fish
Technical grade active
Chronic
ingredient

Proposed Re-evaluation Decision – PRVD2015-01
Page 226

 Appendix X

Test Material

Exposure

Endpoint Value
(mg ag/L)

Crop-Region
(Use Rate g a.e./ha, Application
Interval)

Marine/estuarine algae
EUP With POEA
Chronic
HC5: 0.33
Potato – PEI (4320)
Shaded cells and bold values indicate that the level of concern is exceeded (RQ > 1).

Table X.30

EEC
(mg a.e./L)

RQ

LOC
Exceeded

0.078

0.23

No

Further Risk Characterization of Glyphosate Technical, Glyphosate Formulations, Transformation Product
AMPA and the Formulant POEA Exposed to Aquatic Organisms Using Freshwater Monitoring Data in
Different Crop Productions

Test Material

Exposure

Endpoint Value
(mg ae/L)

EEC
(mg a.e./L)

RQ

LOC Exceeded

Acute
Chronic

HC5: 0.19
NOEC: 0.27

0.041
0.041

0.22
0.15

No
No

Acute

½ EC50: 1.15

0.041

0.04

No

Chronic

NOEC: 0.36

0.041

0.11

No

Acute
Chronic

HC5: 0.93
HC5: 0.86

0.041
0.041

0.04
0.05

No
No

Freshwater Invertebrate
EUP With POEA
Freshwater Snails
EUP With POEA
Freshwater Fish
EUP With POEA
Freshwater Amphibians
EUP With POEA

Freshwater Algae
EUP Non-POEA
Acute
HC5: 0.06
0.041
0.68
No
EUP With POEA
Chronic
HC5: 0.42
0.041
0.1
No
Freshwater Plants
EUP With POEA
Chronic
HC5: 0.003
0.041
14
Yes
Shaded cells and bold values indicate that the level of concern is exceeded (RQ > 1). No monitoring data were available for marine/estuarine environment.

Proposed Re-evaluation Decision – PRVD2015-01
Page 227

 Appendix 

 

 

Proposed Re?evaluation Decision PRVD2015-01
Page 228

Appendix XI

Appendix XI Glyphosate Aquatic Ecoscenario and Drinking Water
Assessment
Modelling Results
Aquatic Ecoscenario Assessment: Level 1 Modelling
For Level 1 aquatic ecoscenario assessment, estimated environmental concentrations (EECs) of
glyphosate from runoff into a receiving water body were simulated using the PRZM/EXAMS
models. The PRZM/EXAMS models simulate pesticide runoff from a treated field into an
adjacent water body and the fate of a pesticide within that water body. For the Level 1
assessment, the water body consists of a 1 ha wetland with an average depth of 0.8 m and a
drainage area of 10 ha. A seasonal water body was also used to assess the risk to amphibians, as
a risk was identified at the screening level. This water body is essentially a scaled-down version
of the permanent water body noted above, but having a water depth of 0.15 m. EECs for
glyphosate in pore water were also generated in a water body with an average depth of 0.8 m.
A number of initial application dates between April and November were modelled. Table 2
lists the application information and the main environmental fate characteristics used in the
simulations. The EECs are for the portion of the pesticide that enters the water body via runoff
only; deposition from spray drift is not included. The models were run for 50 years for all
scenarios. The major groundwater and surface water model inputs for level 1 assessment
used the combined residues of glyphosate and its transformation product AMPA as the most
conservative values in potential sources of drinking water. The major input parameters for the
model are summarized in TableXI.1.
The EECs are calculated from the model output from each run as follows. For each year of
the simulation, PRZM/EXAMS calculates peak (or daily maximum) and time-averaged
concentrations. The time-averaged concentrations are calculated by averaging the daily
concentrations over five time periods (96-hour, 21-day, 60-day, 90-day, and 1 year). The
90th percentiles over each averaging period are reported as the EECs for that period.
The largest EECs of all selected runs of a given use pattern/regional scenario are reported in
Tables XI.3-5, Appendix XI.

Proposed Re-evaluation Decision – PRVD2015-01
Page 229

 Appendix XI

Table XI.1
Type of Input

Major Groundwater and Surface Water Model Inputs for Level 1
Assessment of Glyphosate and AMPA (Combined Residues)
Parameter
Crop(s) to be treated
Maximum allowable
application rate per year
(g a.i./ha)

Application
Information

Maximum rate each application
(g a.i./ha)
Maximum number of
applications per year
Minimum interval between
applications (days)
Method of application
Hydrolysis half-life at pH 7
(days)
Photolysis half-life in water
(days)
Adsorption KOC (mL/g)

Environmental Aerobic soil biotransformation
Fate
half-life (days)
Characteristics

Aerobic aquatic
biotransformation half-life
(days)

Anaerobic aquatic
biotransformation half-life
(days)

Value
Apple, potato, wheat, canola, corn, soybean,
turf and sod, and other crops
12600 for apple
10445 for corn
9542 for canola, wheat and soybean
4320 for potato and other crops
4320 for all crops
3 for apple, canola, wheat and soybean
4 for corn
1 for potato and other crops
14 for apple and corn
10 for canola, wheat and soybean
Aerial and ground for drinking water
modelling
ground for ecological modelling
Stable for the combined residue
1627 for parent glyphosate
216
30 (20th percentile of 11 Kd values for
“AMPA”) for drinking water modelling
48.8 (20th percentile of 10 Kd values for
“glyphosate”) for ecological modelling
135.3 (90th percentile confidence bound on
mean of 4 half-life values adjusted to 25ºC
for the combined residue for drinking water
modelling)
32.6 (90th percentile confidence bound on
mean of 7 half-life values adjusted to 25ºC
for glyphosate for ecological modelling)
637 (80th percentile of 3 half-life values for
the combined residue for drinking water
modelling)
413.6 (80th percentile of 3 half-life values for
glyphosate for ecological modelling)
617 (the only half-life value available for the
combined residue for drinking water
modelling)
273 (the only half-life value available for
glyphosate for ecological modelling)

Proposed Re-evaluation Decision – PRVD2015-01
Page 230

 Appendix XI

Table XI.2

Crops, Rates Modelled at Level 1 Ecoscenario Modelling

Region

Crop

British Columbia

Prairie

Ontario
Québec
Table XI.3

Apple
Canola
Canola, wheat,
soybean
Canola, wheat,
soybean
Apple
Corn
Apple

Rate in kg a.e./ha; Application
Interval in Days
12.6 (2 × 4.32 + 3.96; 14)
9.542 (2 × 4.32 + 0.902; 10)
9.542 (2 × 4.32 + 0.902; 10)

Apple – BC
Barley – AB
Wheat – MB

9.542 (2 × 4.32 + 0.902; 10)

Wheat – SK

12.6 (2 × 4.32 + 3.96; 14)
10.445 (2 × 4.32 + 2x0.903; 14)
12.6 (2 × 4.32 + 3.96; 14)

Apple – ON
Corn – ON
Apple – QC

Scenario

Level 1 Aquatic Ecoscenario Modelling EECs (µg a.e./L) in Water Column
for Glyphosate in a Water Body 0.8 m Deep, Excluding Spray Drift

Crop – Region

Peak

Apple – British Columbia
Canola – British Columbia
Canola, wheat, soybean – Manitoba
Canola, wheat, soybean –
Saskatchewan
Apple – Ontario
Corn – Ontario
Apple – Québec
Corn – Québec
Potato, soybean and others –
Prince Edward Island
Maximum

EEC (µg a.i./L)
2160-Day 90-Day Yearly
Day
1.9
1.4
1.4
1.0
24
23
23
19
41
34
34
27
30
26
24
19

3.4
38
66
57

96Hour
2.8
33
58
47

51
67
38
50
96

42
56
32
44
91

27
37
21
37
78

23
34
20
34
73

22
34
19
34
70

18
29
13
30
58

96

91

78

73

70

58

Proposed Re-evaluation Decision – PRVD2015-01
Page 231

 Appendix XI

Table XI.4

Level 1 Aquatic Ecoscenario Modelling EECs (µg a.e./L) in Water Column
for Glyphosate in a Water Body 0.15 m Deep, Excluding Spray Drift

Crop – Region

Peak

Apple – British Columbia
Canola – British Columbia
Canola, wheat, soybean – Manitoba
Canola, wheat, soybean –
Saskatchewan
Apple – Ontario
Corn – Ontario
Apple – Québec
Corn – Québec
Potato, soybean and others –
Prince Edward Island
Maximum
Table XI.5

EEC (µg a.i./L)
216090Day
Day
Day
2.4
1.7
1.7
31
28
28
54
42
41
39
32
30

15
160
234
192

96Hour
5.9
68
105
87

Yearly

216
234
170
160
255

86
101
65
78
159

35
50
27
49
102

28
42
24
42
89

26
41
23
41
85

22
34
16
36
70

255

159

102

89

85

70

1.3
23
33
23

Level 1 Aquatic Ecoscenario Modelling EECs (µg a.e./L) in Pore Water for
Glyphosate in a Water Body 0.8 m Deep, Excluding Spray Drift

Crop – Region

1.3
21
34
22
21
32
17
33
67

21
32
17
33
67

21
32
17
33
67

21
32
17
33
66

21
32
16
32
65

18
28
13
29
57

67

67

67

66

65

57

Peak

Apple – British Columbia
Canola – British Columbia
Canola, wheat, soybean – Manitoba
Canola, wheat, soybean –
Saskatchewan
Apple – Ontario
Corn – Ontario
Apple – Québec
Corn – Québec
Potato, soybean and others –
Prince Edward Island
Maximum

EEC (µg a.i./L)
216090Day
Day
Day
1.3
1.2
1.2
21
20
20
34
34
34
22
22
22

96Hour
1.3
21
34
22

Yearly
1.0
19
25
19

Estimated Concentrations in Drinking Water Sources: Level 1 and Level 2 Modelling
A Level 1 drinking water assessment was conducted using conservative assumptions with respect
to environmental fate, application rate and timing, and geographic scenario. The Level 1 EEC
estimate is expected to allow for future use expansion into other crops at this application rate.
Table 1 lists the application information and main environmental fate characteristics used in the
simulations.

Proposed Re-evaluation Decision – PRVD2015-01
Page 232

 Appendix XI

A number of initial application dates between March and November were modelled. The model
was run for 50 years for all scenarios. The largest EECs of all selected runs are reported in
Table XI.6 below.
Table XI.6

Level 1 Estimated Environmental Concentrations of the Combined Residue
(Glyphosate and AMPA) in Potential Drinking Water

Compound

Groundwater EEC
(µg a.i./L)
1

Glyphosate and
AMPA
1
2
3
4

Surface Water EEC
(µg a.i./L)
2

Daily

Yearly

0

0

Reservoir
Daily3
Yearly4
299

136

Dugout
Daily
Yearly4
3

1647

1538

90th percentile of daily average concentrations.
90th percentile of yearly average concentrations.
90th percentile of yearly peak concentrations.
90th percentile of yearly average concentrations.

A Level 2 drinking water assessment was conducted using conservative assumptions with
respect to environmental fate, but using crop specific application rate and timing, and geographic
scenario. The Level 2 EEC estimates are therefore not expected to allow for future use
expansion into other crops.
A number of initial application dates between March and November were modelled. The model
was run for 50 years for all scenarios. The largest EECs of all selected runs are reported in
Table 7 that follows.

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 Appendix XI

Table XI.7

Level 2 Estimated Environmental Concentrations of the Combined Residue
(Glyphosate and AMPA) in Potential Drinking Water

Crop

Groundwater EEC
(µg a.i./L)
1

Daily

Surface Water EEC
(µg a.i./L)
2

Yearly

Reservoir
Daily3
Yearly4

Dugout
Daily
Yearly4
3

Apple

NM

5

NM5

150

105

NM5

NM5

Corn

NM5

NM5

131

71

NM5

NM5

Wheat, canola
and soybean

NM5

NM5

267

197

843

780

Potato and
other crops

NM5

NM5

68

44

NM5

NM5

1
2
3
4
5

90th percentile of daily average concentrations.
90th percentile of yearly average concentrations.
90th percentile of yearly peak concentrations.
90th percentile of yearly average concentrations.
NM – not modelled.

Water Monitoring Data
Glyphosate is registered for use in agriculture, forestry and some domestic uses across Canada.
The major environmental transformation product of glyphosate is AMPA (aminomethyl
phosphonic acid). Polyoxyethyleneamine (POEA) is used as a surfactant in some end-use
products containing glyphosate. POEA has been found to be toxic to aquatic organisms.
A search for water monitoring data on glyphosate, AMPA and POEA was conducted. Canadian
water monitoring data on glyphosate and AMPA were available from various relevant regions
in several provinces across the country. No Canadian monitoring data were available for the
surfactant POEA.
United States databases were also searched for monitoring of glyphosate, AMPA and POEA in
water. Data on residues present in water samples taken in the United States are important to
consider in the Canadian water assessment given the extensive monitoring programs that exist
in the United States. Local weather patterns, runoff events, circumstantial hydrogeology as well
as testing and reporting methods are probably more important influences on residue data than
Northern versus Southern climate. Regarding climate, if temperatures are cooler, residues may
break down more slowly. Alternatively, if temperatures are warmer, growing seasons may be
longer and pesticide inputs may be more numerous and frequent.

Proposed Re-evaluation Decision – PRVD2015-01
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 Appendix XI

In the United States, monitoring data were available from the US Geological Survey National
Water Quality Assessment program (NAWQA) database, the US Environmental Protection
Agency’s Storage and Retrieval (STORET) data warehouse, the California Department of
Pesticide Regulation database, and some published literature. Neither glyphosate nor AMPA
were part of the analyte lists in the US Department of Agriculture Pesticide Data Program
(USDA, PDP) and the US Geological Survey National Stream Quality Accounting Network
(NASQAN) program. No monitoring data were available for the surfactant POEA in any of the
US sources searched.
For the purposes of the drinking water assessment, information was extracted from the
available sources, tabulated and sorted into categories as follows:
1. Residues in known drinking water sources (both surface and groundwater).
2. Residues in ambient water that may serve as a drinking water source (both surface and
groundwater).
3. Residues in ambient water that are unlikely to serve as a drinking water source.
Discussions and Conclusions
Overall, available data indicate that glyphosate and AMPA are monitored routinely in
groundwater and surface waters in many use areas of Canada and the United States.
Glyphosate and AMPA are seldom detected in groundwater. This is expected as both compounds
have high Kd and Koc values, and low groundwater ubiquity score (GUS) scores indicating that
they bind tightly to soils and do not have a strong propensity to leach into groundwater.
Glyphosate and AMPA are often detected in surface water. This is expected near areas where
glyphosate is used as it can easily reach water bodies through drift, runoff (likely sorbed to soil
particles), and irrigation canal discharges. Glyphosate is readily soluble in water and is stable
to hydrolysis at environmentally relevant pHs. Glyphosate is also not subject to photochemical
degradation. The duration of glyphosate and AMPA exposure in water can vary based on several
factors, including the amount of organic carbon present in the water body.
The predicted daily and yearly exposure values from the models represent high-end exposure
estimates for drinking water that should be considered in the human health dietary risk
assessment for acute and chronic exposures, respectively. The highest concentrations detected in
surface water samples from sources that may be used as drinking water sources (29 µg/L of
glyphosate, 3.8 µg/L of AMPA, or 32.8 µg/L combined) can also be considered in the acute
assessment. For the chronic assessment for human health, the yearly concentrations estimated via
modelling represent reasonable high-end exposure estimates for drinking water and should be
considered in the human health dietary risk assessment. Monitoring data indicate that glyphosate
and AMPA are often detected in surface water but at relatively low levels.
For the aquatic risk assessment, the highest detection of glyphosate in surface water (40.8 µg/L)
is higher than the peak concentrations predicted by modelling in some scenarios run in water
bodies 80 cm and 15 cm deep. As such, this monitoring value (40.8 µg/L) should be considered
along with the modelling numbers in the acute assessment for aquatic organisms (both 15 cm and
80 cm depths). The value of 3100 µg/L from the prospective monitoring study could also be
considered in the amphibian risk assessment, as a conservative short-term exposure estimate. For
Proposed Re-evaluation Decision – PRVD2015-01
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 Appendix XI

longer term exposures, the concentrations estimated via modelling represent reasonable high-end
exposure estimates for aquatic habitats. Monitoring data indicate that glyphosate and AMPA are
frequently detected in surface water but not at levels that meet or exceed the most sensitive HC5
from species sensitivity distributions (Amphibians, HC5 of NOEC from chronic studies: 1800
µg/L).

Proposed Re-evaluation Decision – PRVD2015-01
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 Appendix XII

Appendix XII Proposed Label Amendments for Products Containing
Glyphosate
The label amendments presented below do not include all label requirements for individual
products, such as first aid statements, disposal statements, precautionary statements and
supplementary protective equipment. Information on labels of currently registered products
should not be removed unless it contradicts the following label statements.
______________________________________________________________________

A) Label Amendments for Glyphosate Technical Products
The following label amendments are required on the Glyphosate Technical labels:
1) Add to the primary panel of the Technical product labels:
The signal words “DANGER – EYE IRRITANT”, and accompanying glyphs.
2) Before STORAGE section, Add the title “ENVIRONMENTAL HAZARDS” and the
following statement:
•
•

TOXIC to non-target terrestrial plants
TOXIC to aquatic organisms

3) Remove the following statement under the “DISPOSAL AND
DECONTAMINATION”
“Canadian formulators of this technical should dispose of unwanted active and containers
in accordance with municipal or provincial regulations. For information on disposal of
unused, unwanted product, contact the manufacturer or the provincial regulatory agency.
Contact the manufacturer and the provincial regulatory agency in the case of a spill, and
for clean-up of spills.”
and replace it with the following statement:
“Canadian manufacturers should dispose of unwanted active ingredients and containers in
accordance with municipal or provincial regulations. For additional details and clean up
of spills, contact the manufacturer or the provincial regulatory agency.”

B) For Commercial and Agricultural Class Products Containing
Glyphosate
1) Add to DIRECTIONS FOR USE:
Restricted Entry Intervals
“The restricted entry interval is 12 hours after application for all agricultural uses.”

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 Appendix XII

2) Add to Use Precautions
“Apply only when the potential for drift to areas of human habitation or areas of human
activity such as houses, cottages, schools and recreational areas is minimal. Take into
consideration wind speed, wind direction, temperature inversions, application equipment
and sprayer settings.”
3) Add the following to ENVIRONMENTAL HAZARDS:
•

TOXIC to non-target terrestrial plants. Observe buffer zones specified under
DIRECTIONS FOR USE.

•

TOXIC to aquatic organisms. Observe buffer zones specified under
DIRECTIONS FOR USE.

•

To reduce runoff from treated areas into aquatic habitats, avoid application to
areas with a moderate to steep slope, compacted soil or clay.

•

Avoid application when heavy rain is forecast.

•

Contamination of aquatic areas as a result of runoff may be reduced by including
a vegetative strip between the treated area and the edge of the water body.

4) Add to DIRECTIONS FOR USE
The following statement is required for all agricultural and commercial pesticide products:
•

As this product is not registered for the control of pests in aquatic systems,
DO NOT use to control aquatic pests

•

DO NOT contaminate irrigation or drinking water supplies or aquatic
habitats by cleaning of equipment or disposal of wastes.

5) Add to DIRECTIONS FOR USE
For field applications using conventional boom sprayers (agricultural or commercial
products), the following statements are required:
Field sprayer application: DO NOT apply during periods of dead calm. Avoid
application of this product when winds are gusty. DO NOT apply with spray droplets
smaller than the American Society of Agricultural Engineers (ASAE) medium
classification. Boom height must be 60 cm or less above the crop or ground.
For airblast applications (agricultural or commercial products), the following statements
are required:

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 Appendix XII

Airblast application: DO NOT apply during periods of dead calm. Avoid application of
this product when winds are gusty. DO NOT direct spray above plants to be treated. Turn
off outward pointing nozzles at row ends and outer rows. DO NOT apply when wind
speed is greater than 16 km/h at the application site as measured outside of the treatment
area on the upwind side.
For aerial applications (agricultural or commercial products) the following statements
are required:
Aerial application: DO NOT apply during periods of dead calm. Avoid application
of this product when winds are gusty. DO NOT apply when wind speed is greater than
16 km/h at flying height at the site of application. DO NOT apply with spray droplets
smaller than the American Society of Agricultural Engineers (ASAE S572.1) coarse
classification. To reduce drift caused by turbulent wingtip vortices, the nozzle
distribution along the spray boom length MUST NOT exceed 65% of the wing  
or rotorspan.
Buffer Zones
Use of the following spray methods or equipment DO NOT require a buffer zone:
hand-held or backpack sprayer and spot treatment.
The buffer zones specified in Tables 1 and 2 that follow are required between the point of
direct application and the closest downwind edge of sensitive estuarine/marine habitats.

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 Appendix XII

Table 1 Buffer Zones for the Protection of Aquatic Organisms and Terrestrial Plants from Spray Drift of Glyphosate
Products Formulated with POEA
Buffer Zones (Metres) Required for the Protection of
Method of Application

Field Sprayer

Crop

Freshwater Habitat of
Depths

Estuarine/Marine
Habitats of Depths

Less than
1m

Greater than
1m

Less than
1m

Greater
than 1 m

1

0

0

0

Terrestrial Habitat

Forest and Woodlands (for sites greater than 500
ha) and Woodland Management (for sites less
than 500 ha): Conifer release for Douglas fir, fir,
hemlock, pine, spruce.
Woodland management: Deciduous release
(ground only) for (partial list) ash, walnut, linden
or basswood, cherry, oak, elm, poplar .
Site preparation (ground only, including sites
greater than 500 ha).
Forest roadside (ground only).
Ground Forest tree planting nurseries (ground
only).
Established deciduous plantings of ash, caragana,
cherry, elm, lilac, maple, mountain ash, poplar,
Russian olive, and willow.
Prior to or in established conifer plantings of fir,
juniper, pine, spruce, and yew.
Shelterbelts.
Nursery stock.
Woody ornamentals including forest tree nursery
and Christmas tree plantations.
Deciduous (ash, caragana, cherry, elm, lilac,
maple, mountain ash, poplar, Russian olive,
willow) and coniferous (fir, juniper, pine, spruce
and yew).
Forest (Short rotation intensive culture (SRIC)
poplar).

Proposed Re-evaluation Decision – PRVD2015-01
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NR

 Appendix XII
Rye, Ginseng – New gardens
Ginseng – Established gardens
Filberts or Hazelnut, Cranberry
Pasture
Summer fallow
Sugar beets (Roundup Ready only)
Highbush blueberry
Canola (glyphosate tolerant)
Corn (glyphosate tolerant)
Forage grasses and legume including seed
production
Corn
Sugar beet
Strawberry,
Lowbush blueberry, Walnut,
Soybean (Glyphosate tolerant, Or Roundup Ready
soybean varieties, or Roundup Ready 2 Yield
soybean varieties), Turf grass (Prior to
establishment or renovation)
Wheat
Barley
Oats
Soybean
Corn – Sweet (Roundup Ready 2 Technology),
Canola
Peas
Dry beans
Flax (including low linoleic acid varieties)
Lentils,
Chickpea,
Lupin (dried)
Fava bean (dried),
Mustard (yellow/white, brown, oriental)
Pearl millet
Sorghum (grain) (not for use as a forage crop)
Asparagus

1
2

1
1

1
1

0
0

1
1

3

1

1

1

2

4

2

1

1

3

5

3

1

1

4

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 Appendix XII
Apple
Apricot
Cherry (sweet/sour)
Peaches
Pears
Plums
Grapes,
Filberts or Hazelnut (pre-seeding)
Non-cropland and industrial uses: Industrial and
rights of way areas*: railroad, pipelines, highway,
telephone and power rights-of-way; petroleum
tank farms, pumping installations, roadsides,
storage areas; lumberyards; fence rows, and
industrial plant sites.

Airblast or Mistblowers

Recreational and public areas such as parking
areas, school yards, parks, golf courses, other
public areas, airports and similar industrial or
non-crop areas.
Forest, Woodlands and woodland management,
Conifer release for Douglas fir, fir, hemlock, pine,
spruce
Deciduous release (ground only) for (partial list)
ash, walnut, linden or basswood, cherry, oak, elm,
poplar
Ground for sites > 500 ha (forest use)
Woodland management
Site preparation (Ground only)
Forest roadside (Ground only)
Forest tree planting, nurseries (ground only)
Established deciduous plantings of ash, caragana
cherry, elm, lilac, maple, mountain ash, poplar,
Russian olive and willow.
Prior to or in established conifer plantings of fir,
juniper, pine, spruce and yew.
Forest and Woodlands, Site preparation for sites
> 500 ha
Pasture

10

4

1

1

5

2

0

0

0

NR

4

0

0

0

NR

40

30

5

2

35

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 Appendix XII

Aerial

Non-crop land and industrial uses:
Industrial and rights of way areas*: railroad,
pipelines, highway, telephone and power rightsof-way; petroleum tank farms, pumping
installations, roadsides, storage areas;
lumberyards; fence rows, industrial plant sites
Recreational and public areas such as parking
areas, school yards, parks, golf courses, other
public areas, airports and similar industrial or
non-crop areas.

45

35

10

3

40

Turf grass (prior to establishment or renovation)

45

35

10

4

40

Fixed wing

15

10

0

0

40

Rotary wing

15

10

0

0

40

Fixed wing

30

0

0

0

NR

Rotary wing

20

0

0

0

NR

Fixed wing

25

0

0

0

NR

Rye
Corn
Corn – Sweet
(Roundup
Ready 2
Technology)
Chickpea
Lupin (dried)
Fava bean
(dried)
Mustard
(yellow/white,
brown,
oriental)
Pearl millet
Sorghum
(grain) (not for
use as a forage
crop)
Sugar beet
Forest and
Woodlands
(for sites > 500
ha): Conifer
release –
Aerial strip
thinning of
conifers
Woodland
management

Proposed Re-evaluation Decision – PRVD2015-01
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 Appendix XII
(for sites
< 500 ha):
Conifer release
for Douglas
fir, fir,
hemlock, pine,
spruce
Forest and
Woodlands
(for sites
> 500 ha): Site
preparation
Woodland
management
(for sites
< 500 ha): Site
preparation
Sugar beets
(Roundup
Ready only)
Wheat
Barley
Oats
Soybean
Canola
Peas
Dry beans
Flax
(including low
linoleic acid
varieties)
Lentils
Forage grasses
and legume
including seed
production
Summer
fallow
Canola
(glyphosate
tolerant)
Soybean
(Glyphosate

Rotary wing

15

0

0

0

NR

Fixed wing

60

0

0

0

NR

Rotary wing

40

0

0

0

NR

Fixed wing

50

0

0

0

NR

Rotary wing

35

0

0

0

NR

Fixed wing

40

15

0

0

60

Rotary wing

30

15

0

0

50

Fixed wing

45

15

0

0

65

Rotary wing

30

15

0

0

55

Fixed wing
Rotary wing
Fixed wing

55
35
60

15
15
20

0
0
0

0
0
0

75
60
65

Rotary wing

45

15

0

0

55

Fixed wing

70

20

0

0

70

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 Appendix XII
tolerant, or
Roundup
Ready soybean
varieties, or
Roundup
Ready 2 Yield
soybean
varieties)
Corn
(glyphosate
tolerant)
Pasture
Non-cropland
and industrial
uses: Industrial
and rights of
way areas*:
railroad,
pipelines,
highway,
telephone and
power rightsof-way;
petroleum tank
farms,
pumping
installations,
roadsides,
storage areas;
lumberyards;
fence rows,
industrial plant
sites.
Recreational
and public
areas- such as
parking areas,
school yards,
parks, golf
courses, other
public areas,
airports and
similar
industrial or
non-crop areas

Rotary wing

45

15

0

0

60

Fixed wing

70

20

0

0

85

Rotary wing

45

15

0

0

65

Fixed wing
Rotary wing

90
60

40
25

0
0

0
0

125
85

Fixed wing

350

200

30

15

300

Rotary wing

150

80

20

4

150

Proposed Re-evaluation Decision – PRVD2015-01
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 Appendix XII

* Buffer zones for the protection of terrestrial habitats are not required for use on rights-of-way including railroad ballast, rail and hydro rights-of-way,
utility easements, roads, and training grounds and firing ranges on military bases.
NR = Buffer zones for the protection of terrestrial habitats are not required for forestry uses.

Table 2. Buffer Zones for the Protection of Aquatic Organisms and Terrestrial Plants from Spray Drift of Glyphosate
Products without POEA
Buffer Zones (Metres) Required for the Protection of
Method of
Application
Field Sprayer

Freshwater Habitat of Depths

Crop

Ginseng – New garden

Terrestrial Habitat

Less than 1 m

Greater than 1 m

1

0

1

1

1

1

1

1

4

Rye
Sugar beets (Roundup ready only)
Ginseng – Established garden
Filberts or Hazelnut – Established
Wheat, barley, oats
Soybean
Corn-Sweet (Roundup-Ready 2 Technology)
Canola,
Canola (glyphosate tolerant)
Peas
Dry beans
Flax (including low linoleic acid varieties)
Lentils
Chickpea
Lupin (dried)
Fava bean (dried)
Mustard (yellow/white, brown, oriental)
Pearl millet
Sorghum (grain) (not for use as a forage crop)
Asparagus

Proposed Re-evaluation Decision – PRVD2015-01
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 Appendix XII

Buffer Zones (Metres) Required for the Protection of
Method of
Application

Freshwater Habitat of Depths

Crop

Less than 1 m

Greater than 1 m

1

1

Terrestrial Habitat

Highbush blueberry
Cranberry
Pasture, Summer fallow
Apple
Apricot, Cherry (Sweet/Sour)
Peaches
Pears
Plums
Grapes
Filberts or Hazelnut – pre-seeding
Soybean (Glyphosate tolerant, or Roundup-Ready
soybean varieties, or Roundup-Ready 2 Yield soybean
varieties)
Turf grass (Prior to establishment or renovation)
Corn (glyphosate tolerant)
Forage grasses and legumes including seed production
Corn
Sugar beet
Strawberry
Lowbush blueberry
Walnut
Non-cropland and industrial uses: Industrial and rights of
way areas*: railroad, pipelines, highway, telephone and
power rights-of-way; petroleum tank farms, pumping
installations, roadsides, storage areas; lumberyards; fence
rows, industrial plant sites.
Recreational and public areas- such as parking areas,
school yards, parks, golf courses, other public areas,
airports and similar industrial or non-crop areas

Proposed Re-evaluation Decision – PRVD2015-01
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5

 Appendix XII

Buffer Zones (Metres) Required for the Protection of
Method of
Application
Airblast or
Mistblower

Freshwater Habitat of Depths

Crop

Terrestrial Habitat

Less than 1 m

Greater than 1 m

Pasture

10

3

35

Turf grass (Prior to establishment or renovation)

15

5

40

Non-crop land and industrial uses: Industrial and rights of
way areas*: railroad, pipelines, highway, telephone and
power rights-of-way; petroleum tank farms, pumping
installations, roadsides, storage areas; lumberyards; fence
rows, industrial plant sites

15

5

40

Fixed wing

0

0

40

Rotary wing

0

0

40

Fixed wing

0

0

60

Rotary wing

0

0

50

Fixed wing

0

0

65

Rotary wing

0

0

55

Recreational and public areas such as parking areas,
school yards, parks, golf courses, other public areas,
airports and similar industrial or non-crop areas.
Aerial

Rye, Corn, Corn-Sweet
(Roundup Ready 2 Technology),
Chickpea, Lupin (dried), Fava
bean (dried)
Mustard (yellow/white, brown,
oriental)
Pearl millet, Sorghum (grain)
(not for use as a forage crop)
Sugar beet
Sugar beets (Roundup Ready
only)
Wheat, Barley, Oats, Soybean
Canola
Peas, Dry beans
Flax (including low linoleic acid
varieties)
Lentils
Canola (glyphosate-tolerant)
Forage grasses and legume
including seed production

Proposed Re-evaluation Decision – PRVD2015-01
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 Appendix XII

Buffer Zones (Metres) Required for the Protection of
Method of
Application

Freshwater Habitat of Depths

Crop

Less than 1 m

Greater than 1 m

Terrestrial Habitat

Corn (glyphosate tolerant)

Fixed wing

0

0

85

Soybean (Glyphosate tolerant,
Or Roundup Ready soybean
varieties, or Roundup Ready 2
Yield soybean varieties)

Rotary wing

0

0

65

Fixed wing

0

0

125

Rotary wing

0

0

185

Fixed wing

40

25

300

Rotary wing

25

15

150

Summer fallow
Pasture

Non-crop land and industrial
uses: Industrial and rights of
way areas*: railroad, pipelines,
highway, telephone and power
rights-of-way; petroleum tank
farms, pumping installations,
roadsides, storage areas;
lumberyards; fence rows,
industrial plant sites
Recreational and public areas
such as parking areas, school
yards, parks, golf courses, other
public areas, airports and similar
industrial or non-crop areas.

* Buffer zones for the protection of terrestrial habitats are not required for use on rights-of-way including railroad ballast, rail and hydro rights-of-way,
utility easements, roads, and training grounds and firing ranges on military bases.

For tank mixes, consult the labels of the tank-mix partners and observe the largest (most restrictive) buffer zone of the products
involved in the tank mixture and apply using the coarsest spray (ASAE) category indicated on the labels for those tank mix partners.

Proposed Re-evaluation Decision – PRVD2015-01
Page 249

 References

References
A.

Studies Considered for the Chemistry Assessment

LIST OF STUDIES/INFORMATION SUBMITTED BY REGISTRANT
PMRA
Reference
Document
Number
699968
2002, Detailed Analysis of Technical Materials Representative of Established Large
Scale Production, DACO: 2.13.3 CBI
1135215

RD314C: Product Chemistry Data to Support the Addition of [CBI Removed] to
Glyphosate Technical Grade and Amendment of Upper Limits of Impurity Levels.
DACO 2.11.2- Description of Starting Materials, DACO: 2.11.2 CBI

1115425

2000, Glyphosate Acid Product Identity and Composition; Description of Material used
to Produce the Product; Description of Manufacturing Process; and Discussion of
Formation of Impurities, DACO: 2.11.4 CBI

1115430

1999, DETERMINATION OF ACTIVE INGREDIENT IN 5 LOTS OF GLYPHOSATE
ACID, TGAI, DACO: 2.13.3 CBI

1115476

2004, Five Batch Chemical Characterization of Chemical Product Technologies’
Technical Grade Glyphosate for the [CBI Removed]. Analytical Raw Data Package.
Residue Analysis Worksheets, Extract Preparation Sheets, Calibration Curves,
Chromatogaphy, Sample Continuity, Sample Preparation Sheets, Standard Preparation
Forms

1135214

RD314C: Product Chemistry Data to Support the Addition of [CBI Removed] to
Glyphosate Technical Grade and Amendment of Upper Limits of Impurity Levels.
DACO 2.11.1 Manufacturing Summary, DACO: 2.11.1 CBI

1135224

2003, Analytical Profile of Glyphosate Technical (Wetcake)/[CBI Removed], DACO:
2.13.3 CBI

1135225

2003, Analytical Profile of Glyphosate Technical (Wetcake)/[CBI Removed], DACO:
2.13.3 CBI

1135226

2003, Analytical Profile of Glyphosate Technical (Wetcake)/[CBI Removed], DACO:
2.13.3

1135227

2004, Analytical Profile of Glyphosate Technical (Wetcake)/[CBI Removed], DACO:
2.13.3 CBI

1135228

2004, Analytical Profile of Glyphosate Technical (Wetcake)/[CBI Removed], DACO:
2.13.3

1161987

Glyphosate Chemistry Requirements, DACO:
2.1,2.11,2.12.1,2.13,2.14,2.15,2.2,2.3,2.4,2.5,2.6,2.7,2.8,2.9 CBI

Proposed Re-evaluation Decision – PRVD2015-01
Page 250

 References

1161988

2001, Studies on the impurity profile of glyphosate technical (five batch analysis),
DACO: 2.13 CBI

1216694

1996, Glyphosate Acid: Product Identity, Description of Beginning Materials and
Manufacturing Process and Discussion of the Formation of Impurities, DACO:
2.11.1,2.11.2,2.11.3,2.11.4 CBI

1216698

1996, Glyphosate Acid: Detailed Analysis of Technical Materials Representative of
Large Scale Production, DACO: 2.13.1,2.13.2,2.13.3,2.13.4 CBI

1309463

2006, Glyphosate Technical Acid, [CBI Removed] Product Identity and Process, DACO:
2.11,2.11.1,2.11.2,2.11.3,2.11.4 CBI

1309466

2006, Glyphosate Technical Acid, [CBI Removed] Product Identity and Process, DACO:
2.11,2.11.1,2.11.2,2.11.3,2.11.4 CBI

1309467

2006, Glyphosate Technical Acid, [CBI Removed] Product Identity and Process, DACO:
2.11,2.11.1,2.11.2,2.11.3,2.11.4 CBI

1309468

2006, Glyphosate Technical Acid, [CBI Removed] Product Identity and Process, DACO:
2.11,2.11.1,2.11.2,2.11.3,2.11.4 CBI

1309470

2005, Glyphosate Technical Five-Batch Analysis [CBI Removed], DACO:
2.13,2.13.1,2.13.2,2.13.3,2.13.4 CBI

1309471

2006, Glyphosate Technical Acid, [CBI Removed] Preliminary Analysis, DACO:
2.13,2.13.1,2.13.2,2.13.3,2.13.4 CBI

1309472

2006, Glyphosate Technical Acid, [CBI Removed] Preliminary Analysis II, DACO:
2.13,2.13.1,2.13.2,2.13.3,2.13.4 CBI

1309473

2006, Glyphosate Technical Acid, [CBI Removed] Preliminary Analysis, DACO:
2.13,2.13.1,2.13.2,2.13.3,2.13.4 CBI

1309475

2006, Glyphosate Technical Acid, [CBI Removed] Preliminary Analysis II, DACO:
2.13,2.13.1,2.13.2,2.13.3,2.13.4 CBI

1309476

2006, Glyphosate Technical Acid, [CBI removed] Preliminary Analysis, DACO:
2.13,2.13.1,2.13.2,2.13.3,2.13.4 CBI

1309477

2006, Glyphosate Technical Acid, [CBI Removed] Preliminary Analysis II, DACO:
2.13,2.13.1,2.13.2,2.13.3,2.13.4 CBI

1357237

2007, Batch data for manufacturing sites converted to dry weight, DACO: 2.13.3 CBI

1357239
1362712

2007, Excel table of batch data converted to dry weight, DACO: 2.13.3 CBI
2006, Description of Materials Used to Produce the Product, Description of
Manufacturing Process, and Discussion of Formation of Impurities for Glyphosate
Technical (GF-1548), DACO: 2.11.1,2.11.2,2.11.3,2.11.4 CBI

1362713

2006, Group A: Product Identity and Composition, Description of Manufacturing
Process, Discussion of Formation of Impurities, Preliminary Analysis, Certified Limits
and Enforcement Analytical Methods for Glyphosate Technical (GF-1548), DACO:
2.11.1,2.11.

Proposed Re-evaluation Decision – PRVD2015-01
Page 251

 References

1362713

2006, Group A: Product Identity and Composition, Description of Manufacturing
Process, Discussion of Formation of Impurities, Preliminary Analysis, Certified Limits
and Enforcement Analytical Methods for Glyphosate Technical (GF-1548), DACO:
2.11.1,2.11.

1416246

2007, Technical Touchdown Herbicide - Description of Starting Materials, DACO:
2.11.2 CBI

1416247

2007, Technical Touchdown Herbicide - Detailed Production Process Description,
DACO: 2.11.3 CBI

1416259

2006, GLYPHOSATE - DETAILED ANALYSIS OF TECHNICAL MATERIALS
REPRESENTATIVE OF LARGE SCALE PRODUCTION [CBI Removed], DACO:
2.13.3 CBI

1451988

2007, Manufacturing Summary for Glyphosate Technical 97% [CBI Removed], DACO:
2.11.1 CBI

1451989

2007, Description of Materials Used to Produce the Product, DACO: 0.9.1,2.11.2 CBI

1451990

2007, Manufacturing Process for Glyphosate Tech. 97% [CBI Removed], DACO: 2.11.3
CBI

1451996

2007, Group A-Product Chemistry Analysis of Glyphosate, DACO: 2.13.3,2.13.4 CBI

1486635

2007, ANALYSIS WITH RESPECT TO [CBI Removed] OF FIVE
REPRESENTATIVE BATCHES OF GLYPHOSATE TECHNICAL (ASF71)
PRODUCED BY [CBI Removed], DACO: 2.11.4 CBI

1486884

2007, Glyphosate Technical - Preliminary Analysis, DACO: 2.13,2.13.1,2.13.2,
2.13.3,2.13.4 CBI

1486921

2007, Executive summary (DACOs All Parts) 101 amd 103, DACO:
2.1,2.10,2.11,2.11.1,2.11.2,2.11.3,2.11.4,2.12,2.12.1,2.12.2,2.13,2.13.1,2.13.2,2.13.3,
2.13.4,2.14,2.14.1,2.14.10,2.14.11,2.14.12,2.14.13,2.14.14, 2.14.2,2.14.3,2.14.4,2.14.5,
2.14.6,2.14.7,2.14.8

1524674
1524675
1524676

2007, Glyphosate, DACO: 2.11.2,2.11.3,2.11.4 CBI
2007, Manufacturing Summary, DACO: 2.11.1 CBI
2007, Studies on the Chemical Composition of five batches of Glyphosate technical,
DACO: 2.12.1,2.13.1,2.13.2,2.13.3,2.13.4 CBI

1528863

2007, Chemistry requirements for the registration of technical grade of active ingredient
(TGA) or integrated system products, DACO:
2.0,2.1,2.11,2.11.1,2.11.2,2.11.3,2.11.4,2.12, 2.12.1,2.12.2,2.13,2.13.1,2.13.2,2.13.3 CBI

1528863

2007, Chemistry requirements for the registration of technical grade of active ingredient
(TGA) or intergrated system products, DACO: 2.0,2.1,2.11,2.11.1,2.11.2,2.11.3,2.11.4,
2.12,2.12.1,2.12.2,2.13,2.13.1,2.13.2,2.13.3 CBI

1545002

Manufacturing Method for the TGAI, DACO: 2.11.1

Proposed Re-evaluation Decision – PRVD2015-01
Page 252

 References

1545004
1545048
1545050
1552037

Detailed Production Process Description, DACO: 2.11.3
Manufacturing Summary, DACO: 2.11.1
Detailed Production Process Description, DACO: 2.11.3
Technical Chemistry file GPS-CNV-1. Cheminova Agro Glyphosate. Lab No. 92335 and
93107, DACO: 0.8,2.0

1585825

Methods, Specifications, Quality Control Methods, Analytical Method, [CBI Removed],
Chemical and Physical Properties. Include

1614745

2008, NAFST-08-054 GF-1547 Group A Report, DACO: 2.11,2.12,2.13.1,2.13.2 CBI

1614745

2008, NAFST-08-054 GF-1547 Group A Report, DACO: 2.11,2.12,2.13.1,2.13.2 CBI

1620962

2008, Group A: Product Identity and Composition, Description of Materials Used to
Produce the Product, Description of Manufacturing Process, Discussion of Formation of
Impurities, Preliminary Analysis, Certified Limits and Enforcement Analytical Methods

1620962

2008, Group A: Product Identity and Composition, Description of Materials Used to
Produce the Product, Description of Manufacturing Process, Discussion of Formation of
Impurities, Preliminary Analysis, Certified Limits and Enforcement Analytical Methods
for Glyphosate Technical (GF-1548-JG)

1622151
1622152
1622155

2008, 28857 5-Batch Analysis [CBI Removed], DACO: 2.13.3 CBI
2008, 28857 5-Batch Analysis [CBI Removed], DACO: 2.13.3 CBI
2008, NUP 07163 Product Identity and Composition [CBI Removed], DACO:
2.11.1,2.11.2,2.11.4,2.12.1,3.4.1 CBI

1622156

2008, NUP 07169 Product Identity and Composition [CBI Removed], DACO:
2.11.1,2.11.2,2.11.4,2.12.1,3.4.1 CBI

1623665

Chemistry Requirements for the Registration of Technical Grade Active Ingredient
(TGAI) or Integrated System Products: Product Identification, DACO:
2.1,2.11.1,2.11.2,2.11.3,2.11.4, 2.12.1,2.13.2,2.2,2.3,2.3.1,2.4,2.5,2.6,2.7,2.8,2.9 CBI

1623694

Identification and Determination of Active Ingredient Glyphosate (CAS No. 1071-83-6)
and Impurities in Five Samples of Glyphosate Technical, Batch Nos.: 200707001,
200707030, 200707038, 200707069 and 200708032, DACO: 2.13.3 CBI

1629264
1629265
1639244

2008, 2006 Production data from the [CBI Removed] , DACO: 2.13.3 CBI
2008, Additional Production data from the [CBI Removed], DACO: 2.13.3 CBI
2008, Description of the Manufacturing Process of [CBI Removed] Glyphosate Tech,
DACO: 2.11.1,2.11.3,2.2 CBI

1639245
1639249

2008, Raw Material of [CBI Removed] Glyphosate Tech, DACO: 2.11.2 CBI
2008, Purity Profile for 5 batches of Glyphosate Technical, DACO: 2.12.1,2.13.2,2.13.3
CBI

1651365

2008, 28857 5-Batch Analysis, DACO: 2.13.3 CBI

Proposed Re-evaluation Decision – PRVD2015-01
Page 253

 References

1651367

2008, NUP 07164 Product Identity and Composition [CBI Removed], DACO:
2.11.1,2.11.2,2.11.4,2.12.1,3.4.1 CBI

1652570

2008, Identification and Determination of the [CBI Removed] in Five Batches of
Glyphosate Technical, DACO: 2.13.1,2.13.2,2.13.3,2.13.4 CBI

1674967
1674968

2008, Glyphosate, DACO: 2.11.2,2.11.3,2.11.4 CBI
2008, Determination of Active Content and Impurity Profile of Glyphosate, DACO:
2.12.1,2.13.1,2.13.2,2.13.3,2.13.4 CBI

1687773

2008, TOUCHDOWN Technical Herbicide- TGAI Starting Materials, DACO: 2.11.2
CBI

1687774

2008, TOUCHDOWN Technical Herbicide- Detailed Production Process Description,
DACO: 2.11.3 CBI

1687781

2007, TOUCHDOWN Technical Herbicide- Detailed Analysis of Technical Materials
Representative of Large Scale Production [CBI Removed] Final Report, DACO:
2.13.3,2.13.4 CBI

1687782

2007, TOUCHDOWN Technical Herbicide- Glyphosate- Analysis of 5 Samples of
Technical Glyphosate, representative of Large-Scale Production [CBI Removed] Final
Report, DACO: 2.13.3,2.13.4 CBI

1738926

Identification and determination of the relevant impurities [CBI Removed] in five
batches of Glyphosate Technical, Batch Nos. RFYP1089, RFYP1090, RFYP1091,
RFYP1092 AND RFYP1093, DACO: 2.

1741346

Second Amendment to Report: Glyphosate: Batch Analysis Validation of Analytical
Method for the Determination of Various Contents of Impurities in Glyphosate, DACO:
2.13.3 CBI

1760388

Glyphosate Technical Manufacturing Process and Synthesis Pathway, DACO:
2.11.3,2.11.4 CBI

1784115

2009, MEY Glyphosate [CBI Removed] Technical Chemistry Process Description for
PMRA, DACO:
2.1,2.11.1,2.11.2,2.11.3,2.11.4,2.12,2.12.1,2.13.1,2.13.2,2.13.4,2.14.1,2.14.10,
2.14.11,2.14.12,2.14.13,2.14.14,2.14.2,2.14.3,2.14.4,2.14.5,2.14.6,2.14.7,2.14.8,2.14.9,2.

1784120
1793612

Batch Data, DACO: 2.13.3 CBI
2009, TOUCHDOWN Technical- 2008-5897 clarifax - Response to Clarifax from Aug
21 2009 (Lin to Wall), DACO: 2.11.3,2.12.2,2.13.4 CBI

1793613

2007, TOUCHDOWN Technical- 2008-5897 clarifax – [CBI Removed] Fact Sheet,
DACO: 2.11.3 CBI

1793615

2008, TOUCHDOWN Technical- 2008-5897 clarifax - MSDS [CBI Removed], DACO:
2.11.3 CBI

1793616

2007, TOUCHDOWN Technical- 2008-5897 clarifax -Analysis of Samples of Tehcnical
Glyphosate, Representative of Large-scale Production [CBI Removed], DACO: 2.13.4
CBI

Proposed Re-evaluation Decision – PRVD2015-01
Page 254

 References

1804171

1804172

2008, Glyphosate Acid Product Identity and Composition; Description of Material Used
to Produce the Product; Description of [CBI Removed] Manufacturing Process; and
Discussion of Formation of Impurities, DACO: 2.11.1,2.11.2,2.11.3,2.11.4,2.12.1 CBI
2008, Description of Starting Material of [CBI Removed] Glyphosate Tech, DACO:
2.11.2 CBI

1835045

2009, Glyphosate Acid Product Identity and Composition; Description of Material Used
to Produce the Product; Description of Manufacturing Process; and Discussion of
Formation of Impurities, DACO: 2.11.1,2.11.2,2.11.3,2.11.4 CBI

1852368
1874188

2008, Production Process for Glyphosate Technical, DACO: 2.11.2 CBI
2009, Glyphosate Technical Herbicide - Product Identity, Composition, and Analysis
(Group A), DACO:
2.11.1,2.11.2,2.11.3,2.11.4,2.12.1,2.13.2,2.2,2.3,2.4,2.5,2.6,2.7,2.8,2.9 CBI

1874190

2008, Glyphosate Technical Grade Active Ingredient (TGAI) to Determine %
Glyphosate and to Quantify its Associated Impurities, DACO: 2.13.3 CBI

1885532

2008, Purity Profile for 5 Batches of Glyphosate Technical [CBI Removed], DACO:
2.12.1,2.13.1,2.13.3 CBI

1885538

2009, Amendment to Purity Profile for 5 Batches of Glyphosate Technical [CBI
Removed], DACO: 2.12.1,2.13.1,2.13.3

1935666

2008, Determination of [CBI removed] Content in 5 Representative Production Batches
of Glyphosate Technical, DACO: 2.13.3 CBI

1977501
1977502

2010, Summary of Chemistry, DACO: 2.0,2.1,2.14,2.2,2.3,2.4,2.5,2.6,2.7,2.8,2.9 CBI
2010, Summary of Manufacturing Process and Request to Waive data package, DACO:
2.11,2.11.1 CBI

1977503

2008, Quantification and Identification of the Active Ingredient and impurities in five
batches by validated methods, DACO: 2.13,2.13.1,2.13.2,2.13.3,2.13.4 CBI

1977506

2008, Glyphosate Technical: Determination of the [CBI Removed] Content in Five
Batch Samples, DACO: 2.13.4 CBI

1977509

2009, Preliminary Analysis of Five Representative Batches of Glyphosate Acid
Technical Grade Active Ingredient (TGAI) to Determine % Glyphosate and to Quantify
its Associated Impurities, DACO: 2.13,2.13.1,2.13.2,2.13.3,2.13.4 CBI

1977512

2009, Determination of [CBI Removed] Content in Five Representative Production
Batches of Glyphosate Acid Technical, DACO: 2.13,2.13.3,2.13.4 CBI

1977515
1984238
1984240

2010, Summary of Source of Starting Materials, DACO: 2.11.2 CBI
Manufacturing Process, DACO: 2.11.1,2.11.2,2.11.3,2.11.4 CBI
2008, Determination of Active Content and Impurity Profile of Glyphosate, DACO:
2.13.1,2.13.2,2.13.3 CBI

2004622
2004622
2037535
2072231

2009, Study Report Five Batch Analysis of Glyphosate, DACO: 2.13.3,2.13.4 CBI
2009, Study Report Five Batch Analysis of Glyphosate, DACO: 2.13.3,2.13.4 CBI
Amended Final Report, DACO: 2.13.1 CBI
2011, Manufacturing Method, DACO: 2.11 CBI

Proposed Re-evaluation Decision – PRVD2015-01
Page 255

 References

2072232
B.

2011, Manufacturing Method, DACO: 2.11 CBI

Studies Considered for the Toxicological Hazard Assessment

LIST OF STUDIES/INFORMATION SUBMITTED BY REGISTRANT
PMRA
Document
Number
1126881
1126892
1126903
1126905

1149395
1149396
1149397
1156204
1161752
1161753
1161755
1161756
1161758
1161760
1161761
1161763
1161765
1161766
1161768
1161769
1161775
1161777
1161778

Reference

1991, One month feeding study of AMPA administered by capsule to beagle dogs,
DACO: 4.7
1991, 90 Day oral toxicity study of AMPA in dogs, DACO: 4.7
1993, A developmental toxicity study of AMPA in rats, DACO: 4.5.2
1991, An evaluation of the potential of AMPA to induce unscheduled DNA
synthesis in the in vitro hepatocyte DNA repair assay using the male F-344 rat,
DACO: 4.5.4
1993, Correspondence: re- 90 day dog study with AMPA, DACO: 4.7
1991, 90-day oral (capsule) toxicity study in dogs with AMPA. Missing pages
requested as per letter dated October 4,1993, DACO: 4.7
1991, Results of the stability analyses of AMPA (aminomethyl phosphonic acid)
test material used in a 90 day dog study at Wil laboratories, DACO: 4.7
1994, A mouse micronucleus study of AMPA, DACO: 4.5.4
1991, Assessment of acute oral toxicity of (n-methyl-n-phosphonomethyl)glycine
to rats (glyphosate), DACO: 4.2.1
1993, AMPA: acute oral toxicity (limit) test in rats, DACO: 4.2.1
1993, AMPA: acute dermal toxicity (limit) test in rats, DACO: 4.2.2
1989, Glyphosate technical: acute dermal toxicity (limit) test in rats, DACO: 4.2.2
1989, Glyphosate technical acute inhalation toxicity study in rats (limit test),
DACO: 4.2.3
1989, Glyphosate technical: primary eye irritation test in rabbits, DACO: 4.2.4
1989, Compound No.3607: primary eye irritation test in rabbits (glyphosate),
DACO: 4.2.4
1989, Glyphosate technical: primary skin irritation test in rabbits, DACO: 4.2.5
1989, Glyphosate technical: Magnusson-Kligman maximisation test in guinea
pigs, DACO: 4.2.6
1992, AMPA: Magnusson-Kligman maximisation test in guinea pigs, DACO:
4.2.6
1989, Glyphosate 4 week dietary toxicity study in rats, DACO: 4.3.1
1993, AMPA 13 week toxicity study in rats with administration by gavage,
DACO: 4.3.1
1991, Assessment of acute oral toxicity of "glyphosate technical" to mice, DACO:
4.2.1
1989, Glyphosate 13 week dietary toxicity study in rats, DACO: 4.3.1
1991, The effect of glyphosate on pregnancy of the rat (incorporates preliminary
investigation), DACO: 4.5.2
Proposed Re-evaluation Decision – PRVD2015-01
Page 256

 References

1161779
1161780
1161781
1161782
1161783
1161784
1161785
1161786
1161787
1161788
1161790
1161791
1161793
1161794
1161795
1161796
1161797
1161798

1182530
1184695
1184722
1184726
1184727
1184728
1184795
1184837
1184838

1991, The effect of glyphosate on pregnancy of the rabbit (incorporates
preliminary investigation), DACO: 4.5.2
1993, Mutagenicity test: in vitro mammalian cell gene mutation test performed
with mouse lymphoma cells (L5178Y) test compound: AMPA, DACO: 4.5.4
1991, Mutagenicity test: in vitro mammalian cell gene mutation test with
glyphosate, DACO: 4.5.4
1993, Mutagenicity test: Ames salmonella test with AMPA, DACO: 4.5.4
1993, Mutagenicity test: micronucleus test with AMPA, DACO: 4.5.4
1991, Mutagenicity test: micronucleus test with glyphosate, DACO: 4.5.4
1991, Mutagenicity test: Ames salmonella assay with glyphosate, DACO: 4.5.4
1993, Glyphosate 104 week dietary carcinogenicity study in mice, DACO:
4.4.1,4.4.2
1989, Glyphosate 13 week dietary toxicity study in mice, DACO: 4.3.1
1990, Glyphosate 52 week oral toxicity study in dogs, DACO: 4.3.1
1993, Glyphosate 3 week toxicity study in rats with dermal administration,
DACO: 4.3.4
1993, AMPA 4 week dose range finding study in rats with administration by
gavage, DACO: 4.3.8
1992, The effect of dietary administration of glyphosate on reproductive function
of two generations in the rat. Volumes I and II, DACO: 4.5.1
1992, AMPA teratogenicity study in rats, DACO: 4.5.2
1993, Glyphosate 104 week dietary carcinogenicity study in mice. DACO:
4.4.1,4.4.2
1993, Glyphosate 104 week combined chronic feeding/oncogenicity study in rats
with 52 week interim kill.(results after 104 weeks), DACO: 4.4.1, 4.4.2
1993, Glyphosate 104 week combined chronic feeding/oncogenicity study in rats
with 52 week interim kill.(results after 104 weeks), DACO: 4.4.1, 4.4.2
1993, Glyphosate 104 week combined chronic feeding/oncogenicity study in rats
with 52 week interim kill. (Results after 52 weeks) + addendum individual body
weight (g) and food consumption per cage of rats: males and females, DACO:
4.4.1, 4.4.2
1973, The dynamics of accumulation and depletion of orally ingested nphosphonomethylglycine-14C, DACO: 4.5.9
1972, Acute oral toxicity study with CP67573 in albino rabbits, DACO: 4.2.1
1979, Ninety-day subacute toxicity test with aminomethylphosphonic acid
CP50435 in rats, DACO: 4.3.1
1980, Technical glyphosate: teratology study in rats, DACO: 4.5.2
1980, Technical glyphosate: teratology study in rabbits, DACO: 4.5.3
1980, Technical glyphosate: dominant lethal study in mice, DACO: 4.5.4
1972, Ninety-day subacute oral toxicity study with CP67573 in beagle dogs,
DACO: 4.7
1981, A lifetime feeding study of glyphosate (roundup technical) in rats, DACO:
4.4.1, 4.4.2
1981, A lifetime feeding study of glyphosate (roundup technical) in rats, DACO:
4.4.1, 4.4.2

Proposed Re-evaluation Decision – PRVD2015-01
Page 257

 References

1184839
1184851
1184852
1184853
1184879
1184946

1184958

1184959

1184960

1184961

1202148
1211998
1211999
1212000
1212001
1212002
1212003
1212004
1212005
1212006
1212007
1212011
1212012
1212013
1212014

1981, A lifetime feeding study of glyphosate (roundup technical) in rats, DACO:
4.4.1, 4.4.2
1978, Acute oral toxicity study in rats. Compound: glyphosate technical, DACO:
4.2.1
1979, Acute dermal toxicity study LD50 in rabbits. Compound: glyphosate
technical, DACO: 4.2.2
1979, Rabbit eye irritation study. Compound: glyphosate technical, DACO: 4.2.4
1982, A chronic feeding study of glyphosate (roundup technical) in mice, DACO:
4.4.1, 4.4.2
1973, Final report on CP67573 residue and metabolism, part 13: the dynamics of
accumulation and depletion of orally ingested n-phosphonomethylglycine-14C,
DACO: 4.5.9
1973, Final report on CP67573 residue and metabolism, part 8: the gross
metabolism of n-phosphonomethylglycine-14C (cp67573-14C) in the laboratory rat
following a single dose, DACO: 4.5.9
1973, Final report on CP67573 residue and metabolism, part 9: the gross
distribution of n-phosphonomethylglycine-14C (cp67573-14C) in the rabbit,
DACO: 4.5.9
1973, Final report on CP67573 residue and metabolism, part 11: the metabolism
of aminomethylphosphonic acid-14C (CP50435-14C) in the laboratory rat, DACO:
4.5.9
1973, Final report on CP67573 residue and metabolism, part 12: the isolation and
identification of the metabolites of CP67573-14C excreted by the laboratory rat,
DACO: 4.5.9
1985, Twelve month study of glyphosate administered by gelatin capsule to beagle
dogs. DACO: 4.4.1
1996, Glyphosate acid: acute oral toxicity study in rats, DACO: 4.2.1
1996, Glyphosate acid: acute dermal toxicity study in the rat, DACO: 4.2.2
1996, Glyphosate acid: 4-hour acute inhalation toxicity study in rats, DACO: 4.2.3
1997, Glyphosate acid: eye irritation to the rabbit, DACO: 4.2.4
1996, Glyphosate acid: skin irritation to the rabbit, DACO: 4.2.5
1996, Glyphosate acid: skin sensitisation to the guinea pig, DACO: 4.2.6
1996, First revision to glyphosate acid: 90 day feeding study in rats, DACO: 4.3.1
1996, First revision to glyphosate acid: 90 day oral toxicity study in dogs, DACO:
4.3.2
1996, Glyphosate acid: 1 year dietary toxicity study in dogs, DACO: 4.3.2
1996, Glyphosate acid: 21 day dermal toxicity study in rats, DACO: 4.3.5
2001, Glyphosate acid: two year dietary toxicity and oncogenicity study in rats.
[Part 1 of 3], DACO: 4.4.4
2001, Glyphosate acid: two year dietary toxicity and oncogenicity study in rats.
[part 2 of 3], DACO: 4.4.4
2001, Glyphosate acid: two year dietary toxicity and oncogenicity study in rats.
[part 3 of 3], DACO: 4.4.4
2000, Glyphosate acid: multigeneration reproduction toxicity study in rats. [Part 1
of 2], DACO: 4.5.1

Proposed Re-evaluation Decision – PRVD2015-01
Page 258

 References

1212015
1212016
1212017
1212018
1212019
1212020
1212021
1212022
1212023
1212024
1212025
1212026
1212027
1212028
1212029
1212031
1212032
1212033
1212034
1212035
1212037
1212038
1212041
1213949
1235214
1235215
1235339

2000, Glyphosate Acid: multigeneration reproduction toxicity study in Rats. [Part
2 of 2], DACO: 4.5.1
1996, Glyphosate acid: developmental toxicity study in the rat, DACO: 4.5.2
1996, Glyphosate acid: developmental toxicity study in the rabbit, DACO: 4.5.3
1988, Aminomethyl phosphonic acid - an evaluation of mutagenic potential using
S. typhimurium and E. coli, DACO: 4.5.4
1988, Glyphosate acid: mutagenicity evaluation in Salmonella typhimurium,
DACO: 4.5.4
1982, Mutagenicity evaluation in mouse lymphoma multiple endpoint test: a
forward mutation assay, DACO: 4.5.6
1998, Glyphosate acid: in vitro cytogenetic assay in human lymphocyte, DACO:
4.5.6
1996, Glyphosate acid: an evaluation of mutagenic potential using S. typhimurium
and E. coli, DACO: 4.5.6
1996, Glyphosate acid: L5178Y TK+/- mouse lymphoma gene mutation assay,
DACO: 4.5.6
1996, Glyphosate acid: mouse bone marrow micronucleus test, DACO: 4.5.7
1984, Mutagenicity evaluation in Chinese hamster ovary cytogenetic assay,
DACO: 4.5.8
1996, Glyphosate acid: whole body autoradiography in the rat (10mg/kg), DACO:
4.5.9
1996, Glyphosate acid: excretion and tissue retention of a single oral dose
(10mg/kg) in the rat, DACO: 4.5.9
1996, Glyphosate acid: excretion and tissue retention of a single oral dose
(10mg/kg) in the rat following repeat dosing, DACO: 4.5.9
1996, Glyphosate acid: biotransformation in the rat, DACO: 4.5.9
2000, Glyphosate acid: excretion of a single oral dose (10 mg/kg) in the fasted and
non-fasted rat, DACO: 4.5.9
1996, Glyphosate acid: excretion and tissue retention of a single intravenous dose
(10mg/kg) in the rat, DACO: 4.5.9
1996, glyphosate acid: excretion and tissue retention of a single oral dose
(1000mg/kg) in the rat, DACO: 4.5.9
1996, Glyphosate acid: acute neurotoxicity study in rats, DACO: 4.5.12
1988, Aminomethyl phosphonic acid: acute oral toxicity to the rat, DACO: 4.5.12
1996, Glyphosate acid: subchronic neurotoxicity study in rats, DACO: 4.5.13
1996, Glyphosate acid: comparison of salivary gland effects in three strains of rat,
DACO: 4.8
2002, Glyphosate acid: 28 day feeding study in rats, DACO: 4.8
1987, Residue determination of glyphosate and AMPA in laying hen tissues &
eggs following a 28-day feeding study, DACO: 4.3.1,7.5
1990, Chronic study of glyphosate administered in feed to albino rats, DACO:
4.4.1, 4.4.2
1990, Chronic study of glyphosate administered in feed to albino rats, DACO:
4.4.1, 4.4.2
1990, Two generation reproductive feeding study with glyphosate in Sprague-

Proposed Re-evaluation Decision – PRVD2015-01
Page 259

 References

1410983
1411000
1874174
1874176
1874177
1874178
1874186
1874187
2223081

Dawley rats, DACO: 4.5.1
2007, Glyphosate acid technical response to clarifax, DACO: 4.3.1
2007, Glyphosate acid technical response to clarifax, DACO: 4.5.3
2008, Acute oral toxicity study of glyphosate technical in rats, DACO: 4.2.1
2009, Acute dermal toxicity study of glyphosate technical in rats, DACO: 4.2.2
2009, Acute inhalation toxicity study of glyphosate technical in rats, DACO: 4.2.3
2009, Acute eye irritation study of glyphosate technical in rabbits, DACO: 4.2.4
2009, Acute dermal irritation study of glyphosate technical in rabbits, DACO 4.2.5
2009, Skin sensitization study of glyphosate technical in guinea pigs (guinea pig
maximization test), DACO: 4.2.6
2012, Glyphosate - a 28-day oral (dietary) immunotoxicity study in female
B6C3F1 mice, DACO: 4.8

ADDITIONAL PUBLISHED INFORMATION
Note: Only published studies that are cited in the PRVD are listed below; a full list of
published information considered in the re-evaluation is available upon request.
PMRA
Document
Number
2391577
2391578
2391579
2391580
2391581

2391582
2391583

Reference

2009, Toxicokinetics of glyphosate and its metabolite aminomethyl phosphonic
acid in rats, DACO: 4.8
1987, An evaluation of the genotoxic potential of glyphosate, DACO 4.8
1992, NTP technical report on toxicity studies of glyphosate administered in dosed
feed to F344/N rats and B6C3F1 mice, DACO 4.8
2004, Pesticide residues in food – 2004 – joint FAO/WHO meeting on pesticide
residues – part II, DACO: 12.5.4
2009, Reasoned opinion – modification of the residue definition of glyphosate in
genetically modified maize grain and soybeans, and in products of animal origin –
summary, DACO: 12.5.4
2012, Evaluation of developmental toxicity studies of glyphosate with attention to
cardiovascular development, DACO: 12.5.4
2005, Cancer incidence among glyphosate-exposed pesticide applicators in the
agricultural health study, DACO: 12.5.4

C. Studies Considered for the Occupational Risk Assessment
STUDIES/INFORMATION SUBMITTED BY REGISTRANT
PMRA
Document
Number
1212030

Reference

2001, Glyphosate: In vivo Dermal Penetration Study in the Rat. Central
Toxicology Laboratory, Alderley Park, Cheshire, UK #UR0644. Unpublished.

Proposed Re-evaluation Decision – PRVD2015-01
Page 260

 References

OTHER UNPUBLISHED INFORMATION
PMRA
Document
Number
1414011

Reference

1995, Chlorothalonil Worker Exposure during Application of Daconil 2787
Flowable Funigicide in Greenhouses: Lab Project Number: 5968-94-0104-CR001: 94-0104: SDS-2787. Unpublished study prepared by Ricerca, Inc. AH605.
EPA MRID # 43623202 (U.S. EPA Residential SOPs: Sections 3 & 4)

1560575

1997, Carbaryl Mixer/Loader/Applicator Exposure Study during Application of
RP-2 Liquid (21%), Sevin Ready to Use Insect Spray or Sevin 10 Dust to Home
Garden Vegetables. ORETF OMA006. EPA MRID # 44459801 (U.S. EPA
Residential SOP: Sections 3 & 4)

1563670

1999, Integrated Report on Evaluation of Potential Exposure to Homeowners
and Professional Lawn Care Operators Mixing, Loading, and Applying
Granular and Liquid Pesticides to Residential Lawns. Sponsor/Submitter:
Outdoor Residential Exposure Task Force. OMA004/003. EPA MRID #
44972201 (U.S. EPA Residential SOPs; Sections 3 & 4)

1619682

2004, Determination of Potential Dermal Exposure to Adults and Children
Reentering a Pesticide-Treated Turf Area Study Number: ORFO3O.
Unpublished study prepared by Outdoor Residential Exposure Task Force, LLC.
56 p. (MRID 47292001). (U.S. EPA Residential SOPs: Section 3)

1945969

1998, Carbaryl Mixer/Loader/Applicator Exposure Study during Application of
RP-2 Liquid (21%) to Fruit Trees and Ornamental Plants: Lab Project Number:
1518. Unpublished study prepared by Agrisearch Inc., Rhone-Poulenc Ag Co.,
and Morse Laboratories, Inc. 320 p. OMA005. EPA MRID # 44518501 (U.S.
EPA Residential SOPs: Sections 3 & 4)

2115788

Agricultural Reentry Task Force (ARTF). 2008. Data Submitted by the ARTF
to Support Revision of Agricultural Transfer Coefficients. Submission# 20060257.
1999, Evaluation of Transferable Turf Residue Techniques: Evaluation Study of
Transferable Residue Techniques (OMD001) and Transferable Residue
Technique Modification Study: An Evaluation of Three Turf Sampling
Techniques (OMD002). October 7, 1999. Outdoor Residential Exposure Task
Force. EPA MRID 44972203.

2476396
2476401

ADDITIONAL PUBLISHED INFORMATION
PMRA
Document
Number
2409268

Reference

U.S. EPA. 2012. Standard Operating Procedures for Residential Pesticide
Exposure Assessment. EPA, Washington, DC. February, 2012. Sections 3
(Lawns/Turf) and 4 (Gardens and Trees).
Proposed Re-evaluation Decision – PRVD2015-01
Page 261

 References

D. Studies Considered for the Dietary Risk Assessment
LIST OF STUDIES/INFORMATION SUBMITTED BY REGISTRANT
658706
658708
658710

2000, Metabolism of Glyphosate in Roundup Ready Wheat: Introduction and
Summary, Report# MSL-16028.
2000, Metabolism of Glyphosate in Roundup Ready Wheat, Report# MSL16028, 234 pages.
2000, Summary: Level of glyphosate and AMPA residues in Roundup Ready
wheat raw agricultural and processed commodities following applications of
Roundup Ultra Herbicide, Report# MSL-15863, 10 pages.

658710

2000, Summary: Level of glyphosate and AMPA residues in Roundup Ready
wheat raw agricultural and processed commodities following applications of
Roundup Ultra Herbicide, Report# MSL-15863, 10 pages.

658711

1998, Analytical Method for Glyphosate and AMPA in Raw Agricultural
Commodities and their Processed Commodities, Report# RES-008-90, included
as Appendix 7 to Report# MSL-15865.

658713

2000, Magnitude of Glyphosate Residues in Roundup Ready Wheat Raw
Agricultural Commodities and Processed Commodities, Report# MSL-15865.

658713

2000, Magnitude of Glyphosate Residues in Roundup Ready Wheat Raw
Agricultural Commodities and Processed Commodities, Report# MSL-15865.

658714

2001, Magnitude of Glyphosate Residues Following Topical Applications in
Roundup Ready Wheat Raw Agricultural Commodities, Report# MSL-16594.

658715

2001, Waiver Request: Part 7 - Food, Feed and Tobacco Studies – EP Roundup
Transorb Herbicide.
1988, Residue determination of glyphosate and AMPA in laying hen tissues and
eggs following a 28-day feeding study, Report# MSL-6676; Previously
submitted March 4, 1988 (not found on file).

727964

727965

1988, Residue Determination of Glyphosate and AMPA in Swine Tissues
Following a 28-Day Feeding Study, Report# MSL-66276; Previously submitted
March 4, 1988 (not found on file).

727972

1996, Magnitude of Glyphosate Residues in Corn Processed Commodities
Following Preharvest Applications of Roundup Herbicide, Report# MSL13655; Previously submitted July 11, 1996 (not found on file).

727973

1996, Magnitude of Glyphosate Residues in Glyphosate-Tolerant Corn Raw
Agricultural Commodities Following Preharvest Applications of Roundup
Herbicide, Report# MSL-13654; Previously submitted July 11, 1996 (not found
on file).

Proposed Re-evaluation Decision – PRVD2015-01
Page 262

 References

788478

2002, TOUCHDOWN IQ (Glyphosate - Diammonium) Modification of Product
Label to Permit Feeding of Treated Forages, Report# 7.4.1-1.

788479

2002, GLYPHOSATE: Residue Levels on Oats (Grain and Straw) from Trials
Conducted with TOUCHDOWN IQ and TOUCHDOWN XP in Canada during
2001, Report# 7.4.1-2, CER 01307/01.

788480

2001, GLYPHOSATE and GLYPHOSATE-TRIMESIUM: Residue Levels in
Wheat from Trials Conducted in Canada during 2000, Report# 7.4.1-3, RJ
3147B.

788481

1999, GLYPHOSATE-TRIMESIUM: Residue Levels in Wheat from Trials
Conducted in the USA (WRC-99-074) (WINO 24770), Report# 7.4.1-4, RR 99029B.

788482

1992, ICIA0224 ANION: Residues in Corn (Grain and Forage) from a Trial in
Canada during 1989, Report# 7.4.1-5, S38990 92-8.
1999, GLYPHOSATE-TRIMESIUM: Residue Levels in Sweet Corn from
Trials Conducted in the USA (WRC-98- 038) (WINO 21779), Report# 7.4.1-6,
RR 98-017B.

788483

788484

2001, GLYPHOSATE and GLYPHOSATE-TRIMESIUM: Residue Levels in
Dry Peas from Trials Conducted in Canada during 2000, Report# 7.4.1-7, RJ
3143B.

788485

1994, TOUCHDOWN: Processing Study for Residues of GlyphosateTrimesium on Soybeans and Magnitude of the Residue in Soybean Aspirated
Grain Fractions (WRC-93-209) (WINO 8811), Report# 7.4.1-8, RR 93-112B.

788486

1998, GLYPHOSATE-TRIMESIUM: Residue Levels in Alfalfa and Red
Clover from Trials Carried out in Canada During 1995, Report# 7.4.1-9, RJ
2145B.

788487

2001, GLYPHOSATE and GLYPHOSATE-TRIMESIUM: Residue Levels in
Forage (Alfalfa and Red Clover) from Trials Conducted in Canada during 2000,
Report# 7.4.1-10, RJ 3124B.

788488

1999, GLYPHOSATE-TRIMESIUM: Magnitude of the Residue Study on
Alfalfa from Trials Conducted in the United States (WRC-97-083) (WINO
16853), Report# 7.4.1-11, RR 97-039B.

788489

1999, GLYPHOSATE-TRIMESIUM: Residue Levels in Clover from Trials
Conducted in the USA (WRC-97-084) (WINO 16854), Report# 7.4.1-12, RR
97-040B.

788490

1999, GLYPHOSATE-TRIMESIUM Residue Levels in Grasses from Trials
Conducted in the USA (WRC-99-085) (WINO 16855), Report# 7.4.1-13, RR 97
041B.

788491

GLYPHOSATE: Residue Levels on Flax (Seed) from Trials Conducted with
TOUCHDOWN IQ and TOUCHDOWN XP in Canada during 2001, Hampton,
M., Report# 7.4.1-14, CER 01305/01, 01-OCT-02.

Proposed Re-evaluation Decision – PRVD2015-01
Page 263

 References

788492

2002, GLYPHOSATE: Residue Levels on Canola (Seed) from Trials
Conducted with TOUCHDOWN IQ and TOUCHDOWN XP in Canada during
2001, Report# 7.4.1-15, CER 01403/01.

788493

2002, GLYPHOSATE: Residue Levels on Glyphosate-Tolerant Canola (Seed)
from Trials Conducted with TOUCHDOWN IQ in Canada during 2001,
Report# 7.4.1-16, CER 01402/01.

788494

2001, Residue Levels in Glyphosate-Tolerant Canola from Trials Conducted in
Canada during 2000, Report# 7.4.1-17, RJ 3153B.
1997, Touchdown: Determination of Glyphosate N-(phosphonomethyl)glycine
and Aminomethylphosphonic Acid in Animal Products by Gas Chromatography
and Mass Selective Detection (A Revised Method), WRC-97-019, Zeneca
Report# RR93-104B RES, 78 pages.

1051483

1051484

1996, Touchdown: Determination of Residues of the Trimethylsulfonium
Cation in Milk, Eggs, and Animal Tissues by Gas Chromatography, Zeneca
Report# RR93-100B RES.

1051486

1993, Confirmation of the Tolerance Enforcement Method RR 92-0428 Entitled
“Touchdown: Determination of Glyphosate and Aminomethylphosphonic Acid
in Corn Grain, Corn Forage and Corn Fodder by Gas Chromatography and Mass
Selective Detection”, Zeneca Report# RJ 1570B.

1051487

1994, Touchdown: Independent Laboratory Confirmation of the Method RR 93105B for Residues of the Trimethylsulfonium Cation in Agricultural Crops
(WRC-94-029), Zeneca Report# RR 94-019B.

1051488

1994, Touchdown: Independent Laboratory Confirmation of the Method RR 93104B for Residues of Glyphosate and Aminomethylphosphonic Acid in Milk,
Eggs, and Animal Tissues (WRC-94-028), Zeneca Report# RR 94-018B.

1051489

1994, Touchdown: Independent Laboratory Confirmation of the Method RR 93100B for Residues of the Trimethylsulfonium Cation in Milk, Eggs, and Animal
Tissues (WRC-94-026), Zeneca Report# RR 94-017B.

1051492

1993, [14C-Anion]Glyphosate-trimesium: Confined Accumulation Studies on
Rotational Crops (WRC-92-143), Zeneca Report# RR 92-096B, 227 pages.
1993, [14C-TMS]Glyphosate-trimesium: Confined Accumulation Studies on
Rotational Crops, Zeneca Report# RR 93-045B, 117 pages.
1987, Magnitude of SC-0224 Residues In Meat and Milk, Stauffer Chemical
Report# RRC 87-44, 277 pages.
1999, Glyphosate-Trimesium: Magnitude of the Residue Study on Soybeans
from Trials Conducted in the United States (WRC-98-015), Zeneca Report# RR
97-010B FIN.

1051493
1051497
1051499

1051500
1051501

1999, Glyphosate-Trimesium: Residue Levels in Soybeans from Trials
Conducted in the USA (WRC-99-076), Zeneca Report# RR 99-030B.
1987, Magnitude of SC-0224 Residues in Eggs and Poultry, Stauffer Chemical
Report# RRC 87-43, 205 pages.

Proposed Re-evaluation Decision – PRVD2015-01
Page 264

 References

1051502

2000, Relevance of Selected Data to Several Touchdown (Glyphosate)
Formulations, Zeneca Agro, Calgary, Alberta, Canada September 19, 2000, 4
pages.

1051510

2001, Touchdown (Glyphosate Trimethylsulfonium): Response to Registration
Letter Glyphosate Tolerant Soybeans, 20 pages.
2001, Touchdown (Glyphosate Trimethylsulfonium): Response to Registration
Letter Glyphosate Tolerant Soybeans, 20 pages.
2000, Letter from Monsanto to PMRA allowing use of Monsanto’s glyphosate
data to support registration on use in glyphosate tolerant canola and soybeans.

1051510
1051512

1051513
1051514

1051515
1051516

2001, Glyphosate: Residue Levels in Glyphosate Tolerant Soybean from Trials
Conducted in Canada during 2000, Syngenta Report# RJ 3155B.
2001, Glyphosate and Glyphosate-trimesium: Residue Levels in Glyphosate
Tolerant Soybean from Trials Conducted in Canada during 2000, Syngenta
Report# RJ 3152B.
2001, Glyphosate: Residue Levels in Glyphosate Tolerant Soybean from Trials
Conducted in Canada during 2000, Syngenta Report# RJ 3176B.
1999, Glyphosate-trimesium: Residue Levels in Alfalfa and Clover from Trials
Conducted in Canada (WRC-99-125). Report Series RR 99-055B. Unpublished
study prepared by Zeneca, 56 pages.

1051520

2000, Glyphosate-Trimesium: Summary of Metabolism Studies in Livestock in
Support of a Registration Amendment to Include Use in Glyphosate-Tolerant
Soybeans, Zeneca Inc., Report# MERAUG3100A.

1051521

2000, Summary: Glyphosate-Trimesium: Summary of Glyphosate-Tolerant
Soybean Metabolism Studies in Support of a Registration Amendment to
Include Use in Glyphosate-Tolerant Soybeans, Zeneca Inc., Report#
MERAUG3100B.

1051526

1994, The Nature of Residues of Orally Administered [Phosphonomethylene14C] Glyphosate-Trimesium in Goat Tissues and Milk; Report Series RR 93062B.

1051528

1994, Glyphosate Trimesium: Metabolism in Laying Hens following Dosing at
20 mg/kg in the Diet; Report# RJ 1606B.
1994, Glyphosate-Trimesium: Metabolism in Lactating Goats Following Dosing
at 25 mg/kg in the Diet; Report# RJ 1608B.
1997, [14C-Trimethylsulfonium]Glyphosate-Trimesium: Nature of the Residue
in Glyphosate-Tolerant Soybeans (WC-97-062), Zeneca Report# RR 97-029B
INT, Volume 1 of 2.

1051529
1051530

Proposed Re-evaluation Decision – PRVD2015-01
Page 265

 References

1051531

1997, [14C-Trimethylsulfonium]Glyphosate-Trimesium: Nature of the Residue
in Glyphosate-Tolerant Soybeans (WRC-97-061), Zeneca Report# RR 97-028B
INT, Volume 2 of 2.

1051532

2000, Summary: Glyphosate-Trimesium: Summary of Relevant Food and Feed
Residue Studies (Except Supervised Residue Trials) in Support of a Registration
Amendment to Include Use in Glyphosate-Tolerant Soybeans. Summary of
DACOs 7.2.1, 7.2.3, 7.3, 7.4.3, 7.4.6, and 7.5., Zeneca Report#
MERAUG3100C.

1051532

2000, Summary: Glyphosate-Trimesium: Summary of Relevant Food and Feed
Residue Studies (Except Supervised Residue Trials) in Support of a Registration
Amendment to Include Use in Glyphosate-Tolerant Soybeans. Summary of
DACOs 7.2.1, 7.2.3, 7.3, 7.4.3, 7.4.6, and 7.5., Zeneca Report#
MERAUG3100C.

1051532

2000, Summary: Glyphosate-Trimesium: Summary of Relevant Food and Feed
Residue Studies (Except Supervised Residue Trials) in Support of a Registration
Amendment to Include Use in Glyphosate-Tolerant Soybeans. Summary of
DACOs 7.2.1, 7.2.3, 7.3, 7.4.3, 7.4.6, and 7.5., Zeneca Report#
MERAUG3100C.

1051532

2000, Summary: Glyphosate-Trimesium: Summary of Relevant Food and Feed
Residue Studies (Except Supervised Residue Trials) in Support of a Registration
Amendment to Include Use in Glyphosate-Tolerant Soybeans. Summary of
DACOs 7.2.1, 7.2.3, 7.3, 7.4.3, 7.4.6, and 7.5., Zeneca Report#
MERAUG3100C.

1051532

2000, Summary: Glyphosate-Trimesium: Summary of Relevant Food and Feed
Residue Studies (Except Supervised Residue Trials) in Support of a Registration
Amendment to Include Use in Glyphosate-Tolerant Soybeans. Summary of
DACOs 7.2.1, 7.2.3, 7.3, 7.4.3, 7.4.6, and 7.5., Zeneca Report#
MERAUG3100C.
2000, Summary: Glyphosate-Trimesium: Glyphosate-Trimesium: Review of
Supervised Residue Trial Studies in Glyphosate-Tolerant Soybeans and a
Rationale to Support a Waiver of Further Study, Zeneca Report#
MERAUG3100D.

1051533

1071981
1086622
1086623
1086624
1093237

2002, Glyphosate - Residue Levels on Soybeans (Seed) from a Trial Conducted
with Touchdown XP in Canada during 2001, Report# CER 1311/01, 288 pages.
2000, Summary: Metabolism of Glyphosate in Roundup Ready Sugar Beet,
Monsanto Company, Report# MSL-16247, 3 pages.
2001, Livestock Metabolism - Waiver Request: Roundup Ultra Herbicide on
Roundup Ready sugar beet.
2000, Metabolism of Glyphosate in Roundup Ready Sugar Beet, Report# MSL16247, 209 pages.
2001, Summary: Magnitude of Glyphosate residues in Glyphosate-Tolerant

Proposed Re-evaluation Decision – PRVD2015-01
Page 266

 References

Sugar Beet Raw Agricultural commodities, Report# MSL-14542.
1093239

1994, Analytical Method for Glyphosate and AMPA in Raw Agricultural
Commodities, and their Processed Fractions, Report# NSL-14542, version 4;
Protocol #: 96-63-R-1, Doc #: RES-008-90, 24 pages.

1093240
1093241

2001, Waiver Request: Food, Feed and Tobacco Residues Studies.
USEPA Review: Glyphosate, Isopropylamine Salt and Mono-ammonium Salt
on Glyphosate-Tolerant Sugar Beets; Evaluation of Residue Data and Analytical
Methodology; MRID#s 443316-01 to 443316-03; DP# D238398.

1093243

1996, Residues of Glyphosate and AMPA in Beet Containing the Roundup
Ready Gene, following Multiple Applications with MON 52276 Herbicide.
Danish field Trial, 1995, Report# MLL-30454, R.D. No: 1384, 247 pages.
2001, Glyphosate-trimesium: Residue Levels in Lentils from a Trial Conducted
in Canada in 2000 (WRC-00-099), Zeneca Report# RR 00-074B, 274 pages.
2001, Glyphosate-trimesium: Final Report Glyphosate-trimesium: Residue
Levels in Tame Oats from Trials Conducted in Canada in 2000 (WRC-00-097),
Report# RR 00-072B, 447 pages.

1095679
1095680

1095681
1095682

1095683
1095684
1095685
1095686
1095687
1136362

2001, Touchdown (Glyphosate Trimethylsulfonium) Response to Registration
Letter Re: Registration on – Soybeans.
2001, Glyphosate-trimesium: Residue Levels in Non-Glyphosate Tolerant
Soybean from Trials Conducted in Canada during 2000, Report# RJ 3154B, 40
pages.
Touchdown Herbicides: Clarification Response, 2002-04-04, 7 pages.
2001, Touchdown (Glyphosate-Trimethylsulfonium) Response to Registration
Letter Re: Registration on - Oats, Flax and Lentils, 8 pages.
2001, Glyphosate-trimesium: Residue Levels in Flax/solin from Trials
Conducted in Canada During 1998, Report# RJ 3089B.
2001, Glyphosate-trimesium: Residue Levels in Tame Oats from Trials
Conducted in Canada during 1998, Report# RJ3088B.
2001, Glyphosate-trimesium: Residue Levels in Flax From a Trial Conducted in
Canada in 2000 (WRC-00-098), Report# RR 00-073B, 280 pages.
1993, Glyphosate Residues in Alfalfa Hay Following Preharvest Treatments
with Roundup Herbicide in Canada During the 1992 Growing Season, Report#
MSL 12617.

1136714

1988, Germination Studies Following Preharvest Roundup Applications in
Wheat, Corn and Soybeans: Viability and Vigor Study Preharvest Wheat,
Monsanto Study # H83-13-58, 61, 77.

1136725

1979, Germination Study of Seed from Corn Desiccated with Roundup, Study #
H78-13-48; 54.
1978, Germination Study of Soybeans Desiccated with Roundup, Monsanto
Study # H78-13-45.

1136736

Proposed Re-evaluation Decision – PRVD2015-01
Page 267

 References

1136747

1990, Glyphosate Residues in Canadian Wheat Grain and Straw Following
Preharvest Application of Roundup Herbicide – Final Report; Report# MSL9979.

1142081

1986, Experiments on treated and untreated barley with glyphosate – Beer
brewing tests of four malt samples, Report# A 86. 330/250722; Analysis # B850722.

1145559

1989, The nature of the residues of orally administered [phosphonomethyl14C]ICIA0224 in tissues and milk of lactating goats (WRC-89-202), ICI
Americas Co., Study# PMS-136, Report Series RR 89-005B.

1145560

1989, The nature of the residues of orally administered [phosphonomethyl14C]ICIA0224 in tissues and milk of lactating goats (WRC-89-201), ICI
Americas, Inc. Study# PMS-135, Report Series RR 89-004B.

1145561

1989, ICIA 0224: Metabolism on Wheat Following a Pre-harvest Foliar Spray,
Report# RJ 0778B.
1990, ICIA 0224: Uptake and Metabolism in Grape-Vines, Report# RJ0815B.
1985, The Nature of the Residues of SC-0224 in Citrus, Report# PMS-158R;
MRC-86-08.
1989, The nature of the residues of orally administered [phosphono-methyl14C]ICIA0224 in tissues and eggs of laying hens (WRC-89-204), ICI Americas
Inc., Study# PMS-141, Report Series RR 89-007B.

1145563
1145565
1145566

1145567

1989, The nature of the residues of orally administered [trimethyl-sulfonium14C]ICIA0224 in tissues and eggs of laying hens (WRC-89-203), Stauffer
Chemical Company, Study# PMS-139, Report Series RR 89-006B.

1146703

1985, Residue Analytical Method: Determination of SC-0224 cation residues in
crops, water, and soil by gas chromatography, Report# RRC 85-33.
Fate of Isopropylamine Following Preharvest Treatment with Roundup
Herbicide; Residue levels in canola, flax, barley, wheat, soybean grain, field
peas and lentil seeds, Monsanto Company.

1148158

1148769

1993, Détermination des résidus de glyphosate et de son métabolite I’AMPA
dans des échantillons de pailles et de grains de céréales traitées avec Glistar en
France en 1992, Rapport d’Étude Analytique No. RF2052.

1149017

1994, Nature of Glyphosate Residues in Roundup Herbicide Tolerant Canola,
Report# MSL-13318, Final Report, Volume 3 of 3, 319 pages.
1994, Glyphosate Residues in Roundup Tolerant Canola Raw Agricultural
Commodities (1993), Report# MSL13265, Final Report, Volume 2 of 3, 158
pages.

1149029

1149040

1994, Glyphosate Residues in Canadian Canola Raw Agricultural Commodities
and Processed Canola Fractions, Final Report, Report# MS-12781, Volume 1 of
3, 237 pages.

Proposed Re-evaluation Decision – PRVD2015-01
Page 268

 References

1149866

1990, The Analysis of Glyphosate and AMPA in Dry Beans Using Column
Switching-HPLC and Post Column Derivatization Techniques, Report#
D338.REP, 10-89- D338.

1156309
1156527

1988, Glyphosate – Magnitude of Residue on Cranberry, IR-4 Project# 3505.
1994, Addendum to MSL-13265; Glyphosate Residues in Roundup Tolerant
Canola Raw Agricultural Commodities (1993), Report# MSL-13800, 70 pages.
1994, Addendum to MSL-12781: Glyphosate Residues in Canadian Canola
Raw Agricultural Commodities and Processed Canola Fractions (1992), Report#
MSL-13799, 89 pages.

1156602

1158478
1158489

1159941

1160357

1160358

Residue Summaries: Additional Residue Data to Support the Registration of
Preharvest Applications of Roundup Herbicide in Oats (Canadian Trials).
1995, Additional Residue Data to Support the Registration of Preharvest
Applications of Roundup Herbicide in Oats, R.D.# 143 C (Canadian Trial
Results).
Residue Data to Support the Registration of Preharvest Applications of
Roundup Herbicide in Oats, R.D.# 137 C, Submission Date: July 22, 1994, 134
pages.
1988, Petition Amending the Tolerance for Glyphosate in Asparagus, Project#
4, Volume 1 of 2.
1988, Glyphosate - Magnitude of Residue on Asparagus; Report# IR-4 PR
3212, Volume 2 of 2 (submitted in support of Minor Use Submission# 93-514,
Roundup).
1986, Performance and Residue Data to Support a Label Amendment for
Roundup Herbicide; Project # IR-4 PR 1768; Glyphosate/Asparagus (Spot
Treatment/PR 1768/WA Only (submitted in support of Minor Use Submission#
93-514).

1161804

1994, (14C)-Glyphosate: Absorption, Distribution, Metabolism And Excretion
Following Repeated Oral Administration to the Dairy Goat. Final Report,
Report# 676/9-1011.

1161806

1994, (14C)-Glyphosate: Distribution, Metabolism And Excretion Following
Repeated Oral Administration to the Laying Hen. Final Report, Report# 676/81011.

1161823
1161824

Glyphosate Plant Metabolism: A Review of Literature, 1995.
Glyphosate Plant Metabolism: Bibliography prepared for Cheminova Agro A/S,
April 12, 1995.
1994, Touchdown: Processing Study for Residues of Glyphosate-Trimesium on
Wheat and Magnitude of the Residue in Wheat Aspirated Grain Fractions
(WRC-94-066); Report# RR94-041B.

1162496

1162497

1994, Touchdown: Magnitude of the Residue of Glyphosate-Trimesium on
Wheat from Trials Conducted in The USA during 1992, 1993, and 1994 (WRC94-109), Report# RR 94-066B.

Proposed Re-evaluation Decision – PRVD2015-01
Page 269

 References

1166097
1166098

1166099
1166412
1169316
1169318
1169319
1169321
1169322
1169323

1169324
1169325

1169326

1995, Touchdown: Determination of Residues of the Trimethylsufonium Cation
in Agricultural Crops by Gas Chromatography Report# RR 93-105B.
1995, Touchdown: Determination of Glyphosate [N-(phosphonomethyl)glycine]
in Crops by Gas Chromatography and Mass-Selective Detection, Report# RR
92-042B.
Glyphosate-Trimesium: Residue Levels in Spring Wheat from Trials Carried
Out in Canada during 1995, Report# RJ 2087B.
1996, Residue Data in Support of Registration of Roundup Herbicide for Weed
Control in Roundup Ready Soybeans, R.D.# 158 C.
Glyfos vs. Roundup: Bridging Document – Level of Residues of Glyphosate
Following a Preharvest Application, May 1996.
Glyfos Pre-harvest Use in Canada (May 1996): Statistical Analysis: Side by
Side Cereal Trials in Germany and Pre-harvest Cereal Trials in UK.
Glyfos Pre-harvest Use in Canada (May 1996): Comparison of Canadian
Climate and Actual Climate at Trial Sites in Germany and UK.
Glyfos Pre-harvest Use in Canada (May 1996): Summary of Field Trials - UK
and German Cereals.
Glyfos Pre-harvest Use in Canada (May 1996): Summary of Field Trials –
Other Crops.
Glyfos Pre-harvest Use in Canada (May 1996): Summary of Analytical
Methods (Residues Overview of Glyfos: Method of Analysis; Residue Trials
Conducted in Great Britain and Portugal; Residue Trials Conducted in
Germany).
Glyfos Preharvest Use in Canada (May 1996) - Bridging Residue Data for
Glyfos Preharvest: List of References for CHA Reports 1- 67.
Glyfos Preharvest Use in Canada (May 1996) - Bridging Residue Data for
Glyfos Preharvest: Schultz H. (1992) Determination of the Residues of
Glyphosate and AMPA in Cereals (SAG 539 00), Study Project# RCC Project
27S837.
Glyfos Preharvest Use in Canada (May 1996) - Bridging Residue Data for
Glyfos Preharvest: Schultz H. (1992) Determination of the Residues of
Glyphosate and AMPA in Cereals, Study# IF-94/01239-01.

1169327

Glyfos Preharvest Use in Canada (May 1996) - Bridging Residue Data for
Glyfos Preharvest: Schultz H. (1992) Determination of the Residues of
Glyphosate and AMPA in Cereals, Study# IF-93/13831-01.

1171477

EU Review: 91/414/EEC: Review of Glyphosate-trimesium under regulation
3600/92. Document M-II, Section 4: Residues in or on treated products, food or
feed. 12/12/94.

Proposed Re-evaluation Decision – PRVD2015-01
Page 270

 References

1172581

Glyfos Preharvest Use in Canada: Crop Residue Data:
1996, Glyphosate Residues in Wheat following Pre-Harvest Application of
Roundup and Glyfos in Canada 1996 (Field Part), Cheminova Agro A/S. Project
No.: CAN.R.01.
1997, Glyphosate Residues in Barley following Pre-Harvest Application of
Roundup and Glyfos in Canada 1996 (Field Part), Cheminova Agro A/S, Project
No.: CAN.R.02.
1997, Glyphosate Residues in Barley and Wheat following Pre-Harvest
Application of Roundup and Glyfos in Canada 1996 (Analytical Part), Institut
Fresenius, Project No.: IF-96/23606-00.

1175735

MON77175: Temporal Residue Trial Study – Request for Waiver, January 29,
1998.
1998, Additional Residue Data to Support the Registration of MON77175 in
Wheat and Peas; Report# RD 197 C.
1997, Residue Data to Support the Registration of MON77175 on Wheat and
Peas; Report# RD 175 C.
1998, LX1146-02 (Glyphosate Technical) Confined Rotational Crop Study on
Lettuce, Radish, and Wheat in California, LANDIS Protocol# 1651-91-146-0109B-17; PHARMACO Project# 91233/9028, 175 pages. Refer to PMRA Memo
under PMRA# 1608831.

1175739
1175748
1176466

1179872
1181122
1181123
1181124
1181126

1181444
1181555
1182504
1182510
1182519

1998, The Metabolism of Glyphosate in Non-Tolerant And Tolerant Plants,
Report# RD 203 C, 44 pages.
1998, Petition Amending the Tolerance for Glyphosate in Asparagus, Volume 1
of 2, IR-4.
1998, Petition Amending the Tolerance for Glyphosate in Asparagus, Volume 2
of 2, IR-4.
1978, Glyphosate Residues in Asparagus officinalis Samples Following
Roundup Application. Residue Report# A26.
Information to Support Label Amendment Request for Use of Roundup in
Asparagus and Application for Tolerance for Glyphosate in or on Asparagus,
August 13, 1998; Includes Special Report# MSL-0241.
1997, Magnitude of Glyphosate Residues in Glyphosate-Tolerant Sugar Beet
Raw Agricultural Commodities, Report# MSL-14542, RD 1384, 404 pages.
1976, The Metabolism of CP 67573 in Sugar Beets, Final Report, Report# 394,
24 pages.
1974, The Metabolism of CP67573 in Soybeans, Cotton, Wheat and Corn,
Special Report# 334.
1974, Determination of Residues in Meat, Milk and Eggs; Special Report# 334.
1973, Milk and Tissue Residue Study with N-(phosphonomethyl)glycine
(CP67573) in the Cow; Special Report# 334.

Proposed Re-evaluation Decision – PRVD2015-01
Page 271

 References

1182537

1183275

1183277
1183278

1183279
1183280

1183282
1183402

1183403
1183404
1183405
1183406
1183707
1183708

1183710

1974, Information to support the establishment of permanent tolerances and
label registration for the use of Roundup as a preplant herbicide on corn (all
types), soybeans, wheat and other small grains. Section E: Residue Removal +
Section F: Proposed tolerances + Section G: Summary and conclusions
(reasonable grounds in support of the petition for residue tolerance); Special
Report# 334.
Summary (1997): Glyphosate-trimesium: Residue Studies: Residue levels in
soybeans from trials carried out in Canada during 1995; Magnitude of residues
on soybeans in the U.S.; Summary of residue table, Residues in common dry
beans Canada 1995; Residue in dried shelled peas and beans U.S.; processing
soybeans Mississippi, and table of contents.
1997, Glyphosate-trimesium: Residue Levels in Soybeans from Trials carried
out in Canada during 1995, Report# RJ2359B.
1997, Glyphosate-Trimesium: Magnitude of the Residue on Soybeans from
Trials Conducted in the United States (WRC-97-027), Report# RR 97-009B
INT.
1997, Glyphosate-trimesium: Residue Levels in Common Drybeans from Trials
carried out in Canada during 1995, Report# RJ 2343B.
1997, Glyphosate-trimesium: Magnitude of the Residue Study on Dried Shelled
Peas and Beans from Trials Conducted in the United States, Report# RR 97015B.
1997, Glyphosate-trimesium: Processing Study on Soybeans from a Trial
Conducted in Mississippi (WRC-97-023), Report# RR 97-009B.
Summary (1995): Glyphosate-trimesium: Residue levels in screened barley
grain, malt and beer samples generated by BRF International (Technical Letter);
Residue levels in processed canola fractions, field peas, spring canola, spring
barley, 10/6/95. Report #s 94JH286/02; TMJ 3826B; RJ 2170B; RJ 2315B; RJ
2183B; RJ 2325B; RJ 2119B; RJ2311B.
1997, Glyphosate-Trimesium: Residue Levels in Field Peas from Trials carried
out in Canada during 1995, Report# RJ 2170B.
1997, Residue Levels in Field Peas from Trials carried out in Canada during
1996, Report# RJ 2315B.
1996, Glyphosate-Trimesium: Residue Levels in Spring Canola from Trials
carried out in Canada during 1995, Report# RJ 2183B.
1997, Residue Levels in Spring Canola from Trials carried out in Canada during
1995, Report# RJ 2325B.
1996, Glyphosate-Trimesium: Residue Levels in Spring Barley from Trials
carried out in Canada during 1995, Report# RJ 2119B.
1997, Glyphosate-Trimesium Storage Stability of Residues of N(phosphonomethyl) glycine and Trimethylsulphonium Cation in Coffee Stored
Frozen at < -18C, Report# RJ 2256B.
1992, Touchdown: Magnitude-of-the-Residue Study on Grapefruits, Lemons
and Oranges (WRC-91-199), Report# RR 91-099B.

Proposed Re-evaluation Decision – PRVD2015-01
Page 272

 References

1183711
1183718
1183740
1183752

1992, Touchdown: Magnitude-of-the-Residue Study on Grapes (WRC-92-019),
Report# RR 92-015B.
1997, Glyphosate-Trimesium: Residue Levels in Spring Barley from Trials
carried out in Canada during 1996, Report# RJ 2311B.
1997, Glyphosate-Trimesium: Residue Levels in Processed Canola Fractions,
Report# TMJ 3826B.
Summaries (1998): Letter addressing data deficiencies: freezer storage stability
tests and supervised residue studies in field peas and spring barley and storage
stability of residues in crop matrices (barley, oats, lentils, canola, peas, soybean,
dry bean, forages and flax), 4/21/98 and 4/30/98.

1183752

Summary (1998): Letter addressing data deficiencies: freezer storage stability
tests and supervised residue studies in field peas and spring barley and storage
stability of residues in crop matrices (barley, oats, lentils, canola, peas, soybean,
dry bean, forages and flax), 4/21/98 and 4/30/98.

1183763

1989, ICIA 0224 - Storage Stability Study: Crops Storage Stability Validation
for ICIA 0224 in Raw Agricultural Commodities, Study # WRC 89-22.
1996, Glyphosate-trimesium: Storage Stability of Residues of N(phosphonomethyl)glycine and Trimethylsulphonium Cation in Banana,
Report# RJ 2161B.

1183766

1183767

1995, Glyphosate-trimesium: Storage Stability Study of Residues of N(phosphonomethyl)glycine (PMG) and Trimethylsulphonium Cation (TMS)
(both derided from Glyphosate-trimesium) in Processed Fractions of Winter
Wheat and Common Oats, Report# RJ 2030B.

1183768

1995, Glyphosate-trimesium: Storage Stability Study of Residues of N(phosphonomethyl)glycine (PMG) and Trimethylsulphonium Cation (TMS+)
(both derived from Glyphosate-trimesium) in Winter Wheat Grain and Grass,
Report# RJ 1914B.

1184003

1998, Glyphosate-trimesium: Residue Levels in Flax/Solin from Trials carried
out in Canada during 1997, Report# RJ 2477B.
1998, Glyphosate-trimesium: Residue Levels in Flax from Trials carried out in
Canada during 1995, Report# RJ 2430B.
1997, Glyphosate-trimesium: Residue Levels in Lentils from Trials carried out
in Canada during 1995, Report# RJ 2146B.
1998, Glyphosate-trimesium: Residue Levels in Lentils from Trials carried out
in Canada during 1997, Report# RJ 2476B.
1997, Glyphosate-trimesium: Residue Levels in Tame Oats from Trials carried
out in Canada during 1996, Report# RJ 2398B.
1998, Glyphosate-trimesium: Residue Levels in Tame Oats from Trials carried
out in Canada during 1997, Report# RJ 2475B.

1184005
1184007
1184008
1184009
1184010

Proposed Re-evaluation Decision – PRVD2015-01
Page 273

 References

1184018

Summary of previously submitted data to address data requirements for DACO
7.1, 7.2.1, 7.4.1, and 7.4.2 – Crop Residues; includes a Table - "Summary of
Soybean Residue Data for Trials including a late Post-emergent Treatment".

1184024

Summary of previously submitted data to address data requirements for DACO
7.1, 7.2.1, 7.4.1, 7.4.2 – Crop Residues.
1998, Summary: Magnitude of Glyphosate Residues in Roundup Ready Corn
Raw Agricultural Commodities in Canada, Report# MSL-14691.
1998, Magnitude of Glyphosate Residues in Roundup Ready Corn Raw
Agricultural Commodities in Canada, Report# MSL-14691, Supervised Residue
Trial Analytical Methodology, 104 pages.

1184296
1184297

1184298

1184299

1184300
1184301

1184302
1184306

1184338

1998, Appendix 3 of Report# MSL-14691: Magnitude of Glyphosate Residues
in Glyphosate-Tolerant Corn Raw Agricultural Commodities in Canada; incl.
Study# 96-63-R-2 (1996), 179 pages.
Temporal Residue Trial Data: Residues of Glyphosate and AMPA in Treatment
4 GA21 Corn Forage and Corn Grain Decline Samples - 1997 Trials, March 6,
1998.
1998, Tables from Report# MSL-14691: Magnitude of Glyphosate Residues in
Roundup Ready Corn Raw Agricultural Commodities in Canada, 4 pages.
1998, Tables from Report# MSL-14990: Magnitude of Glyphosate Residues in
Roundup Ready Corn Raw Agricultural Commodities in the U.S. following
Topical Application of Roundup Ultra Herbicide, 7 pages.
1996, Tables from Report# MSL-13882: Magnitude of Glyphosate Residues in
Glyphosate-Tolerant Corn Raw Agricultural Commodities, 10 pages.
1998, Magnitude of Glyphosate Residues in Roundup Ready Corn Raw
Agricultural Commodities in the U.S. following Topical Application of
Roundup Ultra Herbicide, Final Report, Report# MSL-14990, Volume 2 of 2,
661 pages.
1999, Magnitude of Glyphosate Residues in Roundup Ready Wheat Raw
Agricultural Commodities and Processed Commodities Following Topical
Applications of Roundup Ultra Herbicide, DRAFT, Report# 99-63-R-2, 34
pages.

1184338

1999, Magnitude of Glyphosate Residues in Roundup Ready Wheat Raw
Agricultural Commodities and Processed Commodities Following Topical
Applications of Roundup Ultra Herbicide, DRAFT, Report# 99-63-R-2, 34
pages.

1184698

1974, Residue Study with 75% CP67573 XHB-87 AND 25% CP50435 XHD115 in White Leghorn Chickens, Monsanto Company.
1973, Meat Residue Study with CP67573 and CP50435 in Crossbred Swine,
Monsanto Company.
1973, Milk and Meat Residue Study with CP67573 and CP50435 in Dairy
Cattle, Monsanto Company.

1184714
1184725

Proposed Re-evaluation Decision – PRVD2015-01
Page 274

 References

1184736
1184822

1184823

1184857

1973, Milk and Tissue Residue Study with N-(phosphonomethyl)glycine
(CP67573) in the Cow, Monsanto Company.
1977, Residue Studies of N-(phosphonomethyl)glycine: N-nitrosoglyphosate;
Interim Report: Toxicology, Crop Residue and Metabolism Studies of N(phosphonomethyl)-glycine: N-nitrosoglyphosate; Special Report# 478.
1976, Crop Metabolism Studies of N-(phosphonomethyl)glycine: Nnitrosoglyphosate. Interim Report, Report# 477: Toxicology, Crop Residue and
Metabolism Studies of N-(phosphonomethyl)glycine: N-nitrosoglyphosate,
Special Report# 478.
1979, Glyphosate Residues in Potatoes Following Pre-emergent Treatment with
Roundup Herbicide; Final Report, Report# MSL-0677; Information to support
the use of Roundup (13644 PCP Act) as a preplant treatment on potatoes and
sugar beets.

1184858

1979, Glyphosate Residues in Sugar Beets Following Pre-emergent Treatment
with Roundup Herbicide; Final Report, Report# MSL-0690; Information to
support the use of Roundup (13644 PCP Act) as a preplant treatment on
potatoes and sugar beets.

1184868

1974, Final Report on CP67563: Residue and Metabolism, Part 21:
Determination of CP67573 and CP50435 Residues in Grapes; Agricultural
Research Report# 337; Information to support the establishment of permanent
tolerances and label registration of Roundup for weed control in grapes.

1184869

1974, Final Report on CP67573, Residue and Metabolism, Part 20: The
Metabolism of CP67573 in Grape Plants. Agricultural research Report# 335;
Information to support the establishment of permanent tolerances and label
registration of Roundup for weed control in grapes; Special Report# 340.

1184871

Section F: Proposed Tolerance for CP67573, N-(phosphonomethyl)glycine
(Roundup). Information to support the establishment of permanent tolerances
and label registration of Roundup for weed control in grapes; Special Report#
340.
Residues of Roundup (CP67573) and Roundup metabolite (CP50435) in barley
forage, straw, barley grain, oat forage, straw, and oat grain using a single preemergent application.

1184876

1184887

1974, Final Report on CP67573, Residue and Metabolism Part 17:
Determination of crop residues in corn, wheat, soybeans, small grains, soil and
water; Agricultural Research Report No. 325; Special Report# 334.

1184888

1974, Final Report on CP67573, Residue and Metabolism, Part 10: The
Metabolism of CP67573 in Soybeans, Cotton, Wheat and Corn; Information to
support the establishment of permanent tolerances and label registration for the
use of Roundup as a preplant herbicide on corn (all types), soybeans, wheat and
other small grains; Agricultural Research Report# 304; Special Report# 334.

Proposed Re-evaluation Decision – PRVD2015-01
Page 275

 References

1184915

1184920

1184921
1184924

1184926

1184935

1184956

1184956

1188502

1194109

1974, Summary of CP67573 (Roundup) Residue Studies in Crops, Animals,
Soil, Water; Information to support the establishment of permanent tolerances
and label registration for the use of Roundup as a preplant herbicide on corn (all
types), soybeans, wheat and other small grains; Special Report# 334.
1979, A Short Residue Method for Glyphosate Active Ingredient in Roundup
Herbicide; the short method for glyphosate has been evaluated in the following
crops: oranges, lemons + soybean (grain) + soybean (hay) + rice (grain) +
pecans + grapes + tomatoes + lettuce + asparagus + avocados and in
environmental water: Sphagnum Bog water + Day Lake water.
Glyphosate Residue in Pome Fruits, November 15, 1977.
1974, Final Report on CP67573, Residue and Metabolism, Part 18:
Determination of residues in meat, milk and eggs; Agricultural Research
Report# 326; Information to support the establishment of permanent tolerances
and label registration for the use of Roundup as a preplant herbicide on corn (all
types), soybeans, wheat and other small grains, Conkin R. et al.; Special
Report# 334.
1974, Proposed Tolerances for CP67573, N-(phosphonomethyl)glycine
(Roundup). Information to support the establishment of permanent tolerances
and label registration for the use of Roundup as a preplant herbicide on corn (all
types), soybeans, wheat and other small grains, Conkin R. et al.; Special
Report# 334.
1973, Milk and Tissue Residue Study with N-(phosphonomethyl)glycine
(CP67573) in the Cow. Information to support the establishment of permanent
tolerances and label registration for the use of Roundup as a preplant herbicide
on corn (all types), soybeans, wheat and other small grains, Conkin R. et al.;
Special Report# 334.
1974, Summary of CP67573 Metabolism Studies in Plants and Animals:
Information to support the establishment of permanent tolerances and label
registration for the use of Roundup as a preplant herbicide on corn (all types),
soybeans, wheat and other small grains; Special Report# 334.
1974, Summary of CP67573 Metabolism Studies in Plants and Animals:
Information to support the establishment of permanent tolerances and label
registration for the use of Roundup as a preplant herbicide on corn (all types),
soybeans, wheat and other small grains; Special Report# 334.
1997, Residue Analytical Method for the Determination of the
Trimethylsulfonium Cation of Glyphosate-trimesium in Crops, Zeneca
Agrochemicals, Report# SOP RAM 299/01.
Waiver Request - No data were provided for residue review since the surfactant
is an alkyl amine ethoxylate, substantially similar to those currently used in
glyphosate registered products; no significant difference in the fate or
magnitude of the residues of glyphosate resulting from the application of MON
77569 are expected, and all resulting residues are expected to be within
currently established limits.

Proposed Re-evaluation Decision – PRVD2015-01
Page 276

 References

1195776

1996, Residues of Glyphosate and AMPA in Beet Containing the Roundup
Ready Gene, following Multiple Applications with MON 52276 Herbicide, UK
Field Trials, 1995, Report# MLL-30453; RD 1384, 295 pages.

1199094
1199095
1199096
1199097
1199098
1213191

Summary: Glyphosate residues in cranberries.
Crop residue data: Cranberry fruit, 1978.
Crop residue data: Cranberry fruit, 1980.
Crop residue data: Cranberry fruit, 1979.
Residue Analysis: Cranberry fruit, 1981.
2002, Comprehensive Data Summaries: Tier II Summary: Metabolism Data,
DACO Part 6, Glyphosate Acid, 18 pages.
2002, Comprehensive Data Summaries: Tier II Summary: Metabolism Data,
DACO Part 6, Glyphosate Acid, 18 pages.
1994, [14C-PMG] Glyphosate-Trimesium: Nature of the Residue in Tissues and
Eggs of Laying Hens (WRC-93-089); Report Series RR 93-064B.
1994, The Nature of Residues of Orally Administered [Phosphonomethylene14C] Glyphosate-Trimesium in Goat Tissues and Milk (WRC-93-088); Report
Series RR 93-062B.

1213191
1213192
1213194

1213195

1999, Touchdown: Determination of Glyphosate N-(phosphonomethyl)glycine
and Aminomethylphosphonic Acid in Animal Products by Gas Chromatography
and Mass-Selective Detection (a Revised Method), Report# RR 93-104B RES
ADD1, 94 pages.

1213196

1992, [14C-Anion] ICIA0224 - Nature of the Residue: Soybeans (WRC-91189), Unpublished study prepared by ICI Western Research Center, Report#
6.3-1; RR 91-092B, PMS 304, 82 pages.

1213197

1991, Glyphosate-Trimesium: Uptake and Metabolism in USA Grape Vines,
Unpublished study prepared by ICI Jealott’s Hill Research Center, Report# 6.32, RJ 1002B, 105 pages.

1213198

1990, ICIA0224: Uptake and Metabolism in Grape Vines, Report# 6.3-3, RJ
0815B.
1989, ICIA0224: Metabolism on Wheat Following a Pre-Harvest Foliar Spray,
Report# 6.3-4, RJ 0778B.
1985, Glyphosate Residues in Canadian Wheat and Barley following preharvest
application with Roundup Herbicide, Report# MSL-5103.
1984, Glyphosate Residues in Wheat and Wheat grain milling/fractionation
products following preharvest application with Roundup Herbicide, Report#
MSL-3677.

1213199
1224458
1224459

1224459

1984, Glyphosate Residues in Wheat and Wheat grain milling/fractionation
products following preharvest application with Roundup Herbicide, Report#
MSL-3677.

Proposed Re-evaluation Decision – PRVD2015-01
Page 277

 References

1224460
1224461

1984, Residual Aminomethylphosphonic Acid (AMPA) in Preharvest Roundup
Herbicide Treated Crops, Ref. # R 10293.
1983, Residue Analysis for Glyphosate and AMPA in Brassica Seed Crops and
Processed Fractions following preharvest Roundup Herbicide treatments,
Report# MLL 30.104.

1224461

1983, Residue Analysis for Glyphosate and AMPA in Brassica Seed Crops and
Processed Fractions following preharvest Roundup Herbicide treatments,
Report# MLL 30.104.

1224462

1986, Glyphosate residues in Roundup herbicide preharvest treated cereals,
rapeseed, beans, peas, grass, hay and silage, Report# MLL 30.155 (Volume 1 of
2).

1224463

1986, Glyphosate residues in Roundup herbicide preharvest treated cereals,
rapeseed, beans, peas, grass, hay and silage , report# MLL 30.155 (Volume 2 of
2).

1224464

1983, Glyphosate residues in beans following Roundup herbicide preharvest
application, Report# MLL 30.109.
1988, Glyphosate Residues in Canadian Soybeans, Report# MSL-8120.
1987, Glyphosate residues in processed fractions obtained from preharvest
Roundup herbicide treated wheat, barley and oat, Report# MLL 30.179.
1981, Residual glyphosate in processed wheat grains following a preharvest
application of Roundup herbicide in the United Kingdom, Report# MLL 30 069.
1981, Residual glyphosate in processed barley grains following a preharvest
application of Roundup herbicide in the United Kingdom, Report# MLL 30 070.
1988, Uptake and persistence of the herbicide glyphosate (Roundup) in fruit of
wild blueberry and red raspberry, Canadian Forestry Service Program of
Research by the Universities in Forestry, DSS Contract # 01K38-5-0023.
Glyphosate Residues in Forage Legumes and Grasses Following Pre-emergent
Treatment with Roundup Herbicide; Monsanto Company.
1976, Glyphosate Residues in Green and dry Alfalfa following pre-emergent
treatment with Roundup herbicide, Report# 428.
1976, Glyphosate Residues in sugar beets following pre-emergent treatment
with Roundup herbicide, Report# 430.
1976, Glyphosate residues in nuts following post directed treatments with
Roundup herbicide, Report# 442.
1977, Glyphosate residues in seed, pod, leafy and root crop vegetables
following pre-emergent treatment with Roundup herbicide, Report# 470.
1986, Information to support the use of Roundup herbicide applied preharvest to
soybeans with glyphosate residue in soybeans and soybean fractions, Report#
MSL-4671 (Part 1).

1224466
1224467
1224469
1224470
1224471

1224472
1224473
1224474
1224476
1224477
1224478

Proposed Re-evaluation Decision – PRVD2015-01
Page 278

 References

1224478

1986, Information to support the use of Roundup herbicide applied preharvest to
soybeans with glyphosate residue in soybeans and soybean fractions, Report#
MSL-4671 (Part 1).

1224712

1986, Information to support the use of Roundup herbicide applied preharvest to
soybeans with glyphosate residue in soybeans and soybean fractions, Report#
MSL-4671 (Part 2).

1224712

1986, Information to support the use of Roundup herbicide applied preharvest to
soybeans with glyphosate residue in soybeans and soybean fractions, Report#
MSL-4671 (Part 2).

1229171

1989, Glyphosate and AMPA Residues in Canadian Canola and Flax following
preharvest applications of Roundup herbicide, Report# MSL-9049.
1989, Glyphosate Residues in Wheat grain and Straw after Preharvest
Treatment with Roundup Herbicide (Addendum), Report# MSL-8959.
1989, Glyphosate Residues in Canadian barley grain and straw following
preharvest application of Roundup herbicide, Report# MSL-9458.
1989, Glyphosate and AMPA residues in Canadian field peas and lentils
following preharvest applications of Roundup herbicide, Report# MSL-9398.
1989, Metabolism of [14C-Cation] ICIA 0224 in Corn (WRC-89-143), Report#
RR 89-011B.
1989, Metabolism of [14C-Anion] ICIA 0224 in Corn (WRC-89-142), Report#
RR 89-010B.
1986, SC-0224 [14C-TMS] – Nature of the Residue: Soybeans, Lab# PMS-221,
Project# MRC-86-14.
1986, SC-0224 [14C]CAP (Anion), Nature of the Residue: Soybeans, Lab#
PMS-222, Project# MRC-86-16.
1997, Determination of Residues of YRC 2894 480 SC Following Spray
Application on Apple (Fruit, Juice, Pomace, Sauce, Fruit washed, Fruit dried) in
Italy, Report# PF-E/MR; RA-3063/95.

1229281
1230385
1230386
1237190
1237192
1237193
1237194
1241185

1241232

1997, Determination of Residues of YRC 2894 480 SC Following Spray
Application on Apple (Fruit, Juice, Pomace, Sauce, Fruit, washed, Fruit, dried)
in the Federal Republic of Germany, Report# PF-E/MR; RA-3062/95.

1249914

1984, Glyphosate Residues in Tomato Fruit from Canada following Pre-Plant
Treatment with Roundup, Report# MSL-4425.
HPLC-Fluorometric Method for the Analysis of Glyphosate and
Aminomethylphosphonic Acid in Tomatoes, Monsanto Company, 22 pages.
USEPA Review: Residue data submitted in support of minor use of
Roundup/Roundup Dry/Roundup Transorb to control weeds on sugar beets;
USEPA Memo, 8/26/97.

1249915
1255946

Proposed Re-evaluation Decision – PRVD2015-01
Page 279

 References

1325636

2005, Magnitude of Glyphosate Residues in Roundup Ready Sugar Beet Raw
Agricultural Commodities Following Applications of a Glyphosate-Based
Formulation, Canada Trials, Report# MSL-19260.

1367768

Request for FREAS Comment on Glyphosate Residues in Roundup Ready®
Alfalfa, Monsanto Canada Inc., 3 pages.
Summary: Glyphosate residue in/on alfalfa hay as a result of the pre-harvest
application of Roundup herbicide, Monsanto Canada Inc., Report# MSL-12617,
2 pages.

1367769

1380219

2006, Tier II Summary: Environmental Chemistry and Fate Data. Includes
Appendix 1-4: Glyphosate Acid Technical Herbicide – Physical and Chemical
Properties of Pure Material, Syngenta Crop Protection Canada, Inc., 2/28/06,
125 pages, unpublished.

1407428

Summary: Food, feed and tobacco residue studies to support use of Roundup
WeatherMax With Transorb 2 Technology Liquid Herbicide in Roundup
Ready2 Yield soybeans for control of alfalfa and bromegrass and suppression of
field horsetail, Sub# 2007-3205, 06-Apr-2007.

1443091

2007, Magnitude of Glyphosate Residues in Roundup Ready® Soybean Raw
Agricultural Commodities Following Sequential Applications of a GlyphosateBased Formulation at the V3 and R1-R2 Growth Stages, Monsanto Company,
Report# MSL-0020883, 660 pages.

1552809

2007, Analytical Method for the Determination of N-acetylglyphosate and
Other Analytes in Various Animal Matrices Using LC/MS/MS. Project
Identification No. DuPont-20009. Unpublished study prepared by DuPont, 96
pages.

1552811

2007, Independent Laboratory Validation of DuPont-15444, “Analytical
Method for the Determination of Glyphosate and Relevant Metabolite Residues
in Various Crop Matrices Using LC/MS/MS”; Report# DuPont-21313.
Unpublished study prepared by DuPont, 101 pages.

1552814

2007, Independent Laboratory Validation of DuPont-20009, “Analytical
Method for the Determination of N-Acetylglyphosate and other Analytes in
Various Animal Matrices Using LC/MS/MS.” Report# DuPont-21372.
Unpublished study prepared by DuPont, 172 pages.

1552816

2007, Method Assessment and Validation of PAM Multi-Residue Method for
the Determination of N-acetylglyphosate. Report# DuPont-21373. Unpublished
study prepared by DuPont, 84 pages.

1552818

2007, The Metabolism of [14C]Glyphosate in gat/gm-hra (DP-356Ø43-5,
PHP20163a) Soybeans. Study No. DuPont-19530. Unpublished study prepared
by E.I. du Pont de Nemours and Company, 86 pages.

Proposed Re-evaluation Decision – PRVD2015-01
Page 280

 References

1552819

2007, Metabolism of [14C]-N-Acetylglyphosate (IN-MCX20) in Laying Hen.
Study No. DuPont-19795. Unpublished study prepared by E.I. du Pont de
Nemours and Company, 73 pages.

1552821

2007, Metabolism of [14C]-N-Acetylglyphosate (IN-MCX20) in the Lactating
Goat. Study No. DuPont-19796. Unpublished study prepared by E.I. du Pont de
Nemours and Company, 82 pages.

1552822

2007, Magnitude of Residues of N-Acetylglyphosate and Degradates in Laying
Hen Tissues and Eggs. Unpublished study prepared by E.I. DuPont de Nemours
and Company. Study Number: DuPont-20088, 227 pages.
2007, Magnitude of Residues of N-Acetylglyphosate and Degradates in Dairy
Cow Tissues and Milk. Unpublished study prepared by E.I. du Pont de Nemours
and Company; Report# DuPont-20087, 221 pages.
2007, Magnitude of the Residues of Glyphosate and Metabolites in Aspirated
Grain Fractions (AGF) and Processed Fractions (Refined Oil, Meal, and Hulls)
of a Soybean Line Containing Event DP-356Ø43-5 Following Applications of
Glyphosate Containing Herbicides - United States Locations, Season 2006.
DuPont Study No: DuPont-19835. Unpublished study prepared by DuPont, 151
pages.
2007, Aminomethylphosphonic acid (AMPA) in/on soybean processed fractions
(meal, hulls and refined oil) of a soybean line containing event DP-356Ø43-5
following applications of a commercial glyphosate formulation – Chile location,
E. I. du Pont de Nemours and Company, DuPont Report Number: DuPont20093, 53 pages.
2006, Stability of Glyphosate, N-Acetylglyphosate and Aminomethyl
Phosphonic Acid in GAT Soybean Forage, Seed and Hay Stored Frozen:
Interim Report. DuPont Study No: DuPont-17573. Unpublished study prepared
by DuPont, 81 pages.
2007, Toxicological assessment of N-acetyl aminomethylphosphonic acid (INEY252) – Rationale for non-inclusion in glyphosate tolerance expression, E. I.
du Pont de Nemours and Company, Report# DuPont-22309, Revision No. 1, 18
pages.

1552825

1552833

1552834

1552835

1552841

1584178

2007, Analytical Method for the Determination of Glyphosate and Degradate
Residues in Various Crop Matrices Using LC/MS/MS. Project Identification
No. DuPont-15444, Revision No.1. Unpublished study prepared by DuPont, 126
pages.

1594057

2008, Touchdown Total on Glyphosate Tolerant Corn: Rationale For Use of
Waiver of Additional Residue Studies to Support a Registration. DACO Part
7.4.1: Food, Feed and Tobacco Residue Studies (EP) USC #14, Syngenta Crop
Protection Canada, Inc., 5 pages.

1608202

2007, The Metabolism of [14C] Glyphosate in Optimum GAT (Event DPØ9814Ø-6) Field Corn. Study No. DuPont-19529. Unpublished study prepared
by E.I. du Pont de Nemours and Company, 70 pages.

Proposed Re-evaluation Decision – PRVD2015-01
Page 281

 References

1608205

2007, Analytical Method for the Determination of N-Acetylglyphosate and
Other Analytes in Various Animal Matrices using LC/MS/MS, Report#
DuPont-20009.

1608207

2007, Magnitude of Residues of Glyphosate and its Degradates in/on Field Corn
forage, Grain, and Stover of Hybrid Corn Line 49712 containing the GAT Gene
from Event DP-049712-7 Following Applications of Glyphosate Herbicides at
Maximum Label Rates - United States Locations, Season 2005, Report#
DuPont-16701, Revision No.1.

1608224

2007, Magnitude of Residues of Glyphosate and Degradates in Aspirated Grain
and Processed Fractions (Starch, Grits, Flour, Refined Oil (Wet Milling)
Refined Oil (Dry milling) and Meal (Dry Milling) of a Field Corn Line
Containing Event DP-098140-6 Following Application of Glyphosate
Containing Herbicides - United States and Canadian Locations, Season 2006,
Report# DuPont-19836
.
2008, Magnitude and Decline of Residues of Glyphosate and Its Degradates
in/on Forage, Hay and Seed of a Soybean Line Containing Event DP-356Ø43-5
Containing the GAT and GM-HRA Genes Following a Variety of Tank Mix
Applications of Glyphosate Herbicides and Sulfonylurea Herbicides
(Rimsulfuron, Tribenuron Methyl, Chlorimuron Ethyl, and Metsulfuron Methyl)
at Maximum Label Rates - United States and Canadian Locations, Season 2006
[Final Report]. DuPont Study No: DuPont-20123 Volume 1 of 3. Unpublished
study prepared by DuPont, 347 pages.
2008, Magnitude and Decline of Residues of Glyphosate and Its Degradates
in/on Forage, Hay and Seed of a Soybean Line Containing Event DP-356Ø43-5
Containing the GAT and GM-HRA Genes Following a Variety of Tank Mix
Applications of Glyphosate Herbicides and Sulfonylurea Herbicides
(Rimsulfuron, Tribenuron Methyl, Chlorimuron Ethyl, and Metsulfuron Methyl)
at Maximum Label Rates - United States and Canadian Locations, Season 2006
[Final Report]. DuPont Study No: DuPont-20123 Volume 2 of 3. Unpublished
study prepared by DuPont, 346 pages.
2008, Magnitude and Decline of Residues of Glyphosate and Its Degradates
in/on Forage, Hay and Seed of a Soybean Line Containing Event DP-356Ø43-5
Containing the GAT and GM-HRA Genes Following a Variety of Tank Mix
Applications of Glyphosate Herbicides and Sulfonylurea Herbicides
(Rimsulfuron, Tribenuron Methyl, Chlorimuron Ethyl, and Metsulfuron Methyl)
at Maximum Label Rates - United States and Canadian Locations, Season 2006
[Final Report]. DuPont Study No: DuPont-20123 Volume 3 of 3. Unpublished
study prepared by DuPont, 124 pages.

1735244

1735245

1735248

1739972

2007, Magnitude and Decline of Glyphosate and Its Degradates in/on Green
Plant, Forage, Stover and Grain of a Corn Line Containing Event DP-098140-6
GAT and ZM-HRA Genes Following a Variety of Tank Mix Applications of
Two Gyphosate and Rimsulfuron, Tribenuron Methyl, Chlorimuron Ethyl, and
Metsulfuron Methyl Containing Herbicides at Maximum Label Rates – United
Proposed Re-evaluation Decision – PRVD2015-01
Page 282

 References

1739973

1739974

1739976
1754236

States and Canadian Locations, Season 2006. DuPont Study No. DuPont-20122
Volume 1 of 3. Unpublished study prepared by E.I. Dupont, 345 pages.
2007, Magnitude and Decline of Glyphosate and Its Degradates in/on Green
Plant, Forage, Stover and Grain of a Corn Line Containing Event DP-098140-6
GAT and ZM-HRA Genes Following a Variety of Tank Mix Applications of
Two Gyphosate and Rimsulfuron, Tribenuron Methyl, Chlorimuron Ethyl, and
Metsulfuron Methyl Containing Herbicides at Maximum Label Rates – United
States and Canadian Locations, Season 2006. DuPont Study No. DuPont-20122
Volume 2 of 3. Unpublished study prepared by E.I. Dupont, 368 pages.
2007, Magnitude and Decline of Glyphosate and Its Degradates in/on Green
Plant, Forage, Stover and Grain of a Corn Line Containing Event DP-098140-6
GAT and ZM-HRA Genes Following a Variety of Tank Mix Applications of
Two Gyphosate and Rimsulfuron, Tribenuron Methyl, Chlorimuron Ethyl, and
Metsulfuron Methyl Containing Herbicides at Maximum Label Rates – United
States and Canadian Locations, Season 2006. DuPont Study No. DuPont-20122
Volume 3 of 3. Unpublished study prepared by E.I. DuPont, 368 pages.
Response to Deficiency Letter Issued March 25, 2009 for Submission Numbers
2008-2269 and 2008-2270 – DACO 7.3 “Freezer Storage Stability”, 3 pages.
2009, Stability of Glyphosate, N-Acetylglyphosate, Aminomethyl Phosphonic
Acid and N-Acetyl AMPA in GAT Soybean Forage, Seed, and Hay Stored
Frozen. DuPont Study No. DuPont-17573. Unpublished study prepared by
DuPont, 119 pages.

1767015

1993, Magnitude of Glyphosate Residues Following Preharvest Use in Milo
Raw Agricultural Commodities, Monsanto Company, Report# MSL-13037, RD
1192 Volume 2 of 3, 353 pages.

1767016

1994, Magnitude of Glyphosate Residues in Milo Processed Commodities
Following Preharvest Use of Roundup Herbicide, Monsanto Company, Report#
MSL-13038, RD 1192 Volume 3 of 3, 295 pages.

1767017

1998, Magnitude of Glyphosate Residues in Grain Sorghum Raw Agricultural
Commodities Following Preharvest Application of Roundup UltraTM
Herbicide, Monsanto Company, Report# MSL-14918, 269 pages.

1799876

2009, Stability of Glyphosate and Metabolites in Corn Green Plant, Forage,
Grain, and Stover Containing the GAT and ZM-HRA Genes During Frozen
Storage; Report# DuPont-20094, 160 pages.

1808247

2009, Magnitude of Glyphosate Residues in Sweet Corn Raw Agricultural
Commodities Obtained from Roundup Ready Corn 2 ® Technology Following
Applications of a Glyphosate-Based Formulation, U.S. and Canada 2008 Trials.
Monsanto Company, Environmental Sciences Technology Center, Report#
MSL0021170, 428 pages.

1808249

2009, Summary:Magnitude of Glyphosate Residues in Sweet Corn Raw
Agricultural Commodities Obtained from Roundup Ready Corn 2 ®
Technology Following Applications of a Glyphosate-Based Formulation, U.S.
and Canada 2008 Trials. Monsanto Company, Environmental Sciences
Proposed Re-evaluation Decision – PRVD2015-01
Page 283

 References

1833850

1878829

Technology Center, Report# MSL0021170, 3 pages.
2009, Summary: Magnitude of Glyphosate Residues in Corn Raw Agricultural
Commodities Following Applications of a Glyphosate-Based Formulation to
Roundup Hybridization System (RHS) Seed Corn. U.S. 2008 Trials, Monsanto
Company, Report# MSL0022293, 3 pages.
1993, Summary: Glyphosate Residues in Alfalfa Hay Following Pre-harvest
Treatments with Roundup Herbicide in Canada during the 1992 Growing
Season, Monsanto Company, Report# MSL-12617, 3 pages.

1878830

2002, Summary: Magnitude of Glyphosate Residues in Roundup Ready Alfalfa
Raw Agricultural Commodities Following Topical Application of Roundup
Ultra Herbicide, Monsanto Company, Report# MSL-16761, 16 pages.

1879045
1879046
1924479

2010, Residue Data Waiver Rationale - Glyphosate on Mustard, 3/17/10.
PMRA Response to PMRA# 1879045.
2009, Summary: Magnitude of Glyphosate Residues in corn Raw Agricultural
Commodities Following Topical Application of a Glyphosate Based
Formulation to Roundup Hybridization System (RHS) Seed Corn. US 2008
Trials, Monsanto Company, Report# MSL0022293, 4 pages, submitted by
Neyedley B, 12/10/09.

1924480

2009, Magnitude of Glyphosate Residues in Corn Raw Agricultural
Commodities Following Applications of a Glyphosate-Based Formulation to
Roundup Hybridization System (RHS) Seed Corn. U.S. 2008 Trials, Monsanto
Company, Report# MSL0022293, 353 pages.

1924502

Summary: Magnitude of Glyphosate Residues in Roundup Ready Alfalfa Raw
Agricultural Commodities Following Topical Application of a GlyphosateBased Formulation. Canada 2008 Trials, Monsanto Company, Report#
MSL0021171, 3 pages.

1924503

2010, Magnitude of Glyphosate Residues in Roundup Ready® Alfalfa Raw
Agricultural Commodities Following Topical Application of a GlyphosateBased Formulation. Canada 2008 Trials, Monsanto Company, Report#
MSL0021171, 268 pages.

1924504

Summary: Magnitude of Glyphosate Residues in Roundup Ready Alfalfa Raw
Agricultural Commodities Following Topical Application of a GlyphosateBased Formulation. United States Studies, Monsanto Company, Report# MSL16761, 4 pages.

1924505

2002, Magnitude of Glyphosate Residues in Roundup Ready® Alfalfa Raw
Agricultural Commodities Following Topical Application of Roundup Ultra®
Herbicide, Monsanto Company, Report# MSL-16761, 512 pages.

2006672

2009, Analytical Method for the Determination of Glyphosate and Degradate
Residues in Various Crop Matrices Using LC/MS/MS. Project Identification
No. DuPont-15444, Revision No.3. Unpublished study prepared by DuPont, 132
pages.

Proposed Re-evaluation Decision – PRVD2015-01
Page 284

 References

2006674

2006677

2013875

2025578

2025580

2010, Magnitude and Decline of Glyphosate Related Residues in Forage and
Seed of Genetically Modified Canola Event DP-Ø73496-4 and Magnitude of
Glyphosate Related Residues in Canola Event DP-Ø73496-4 Seed Process
Fractions Following Applications of Touchdown Total® Herbicide – Locations
in the United States and Canada, Season 2009; Final Study Report. Project
Numbers: DuPont-27816, ABC Laboratories 64515, Pioneer PHI-2009-057.
Unpublished study prepared by ABC Laboratories, Inc. 513 pages (Volume 1 of
2).
2010, Magnitude and Decline of Glyphosate Related Residues in Forage and
Seed of Genetically Modified Canola Event DP-Ø73496-4 and Magnitude of
Glyphosate Related Residues in Canola Event DP-Ø73496-4 Seed Process
Fractions Following Applications of Touchdown Total® Herbicide – Locations
in the United States and Canada, Season 2009; Final Study Report. Project
Numbers: DuPont-27816, ABC Laboratories 64515, Pioneer PHI-2009-057.
Unpublished study prepared by ABC Laboratories, Inc. 513 pages (Volume 2
of 2).
2010, The Metabolism of [14C] Glyphosate in 0827 Canola. Lab Project No.
808685; Report# DuPont-26109. Unpublished study conducted by Charles
River Laboratories, 74 pages.
2011, Summary: Overview and Tolerance Proposals for Glyphosate Residues in
Glyphosate Tolerant Canola Raw Agricultural Commodities Following
Applications of a Glyphosate-Based Formulation (Overview of Full Study
MRID Nos. 48358101, 48358102, and 48358103), Monsanto Company,
Report# MSL0023286 (MRID 48358105), 10 pages.
2011, OECD Tier II Study Summary: Magnitude of Glyphosate Residues in
Glyphosate Tolerant Canola Raw and Processed Agricultural Commodities
Following Applications of a Glyphosate-Based Formulation (Correlates to Full
Study MRID Nos. 48358101, 48358102, and 48358103), Monsanto Company,
Report# MSL0023285 (MRID 48358104), 20 pages.

2025580

2011, OECD Tier II Study Summary: Magnitude of Glyphosate Residues in
Glyphosate Tolerant Canola Raw and Processed Agricultural Commodities
Following Applications of a Glyphosate-Based Formulation (Correlates to Full
Study MRID Nos. 48358101, 48358102, and 48358103), Monsanto Company,
Report# MSL0023285 (MRID 48358104), 20 pages.

2025582

2011, Magnitude of Glyphosate Residues in Glyphosate Tolerant Canola Raw
Agricultural Commodities Following Applications of a Glyphosate-Based
Formulation 2009 Canadian Trials. Monsanto Study Number: REG-09-101,
Report# MSL0022985. Unpublished study prepared by Monsanto, 241 pages.

2025588

2011, Magnitude of Glyphosate Residues in Glyphosate Tolerant Canola Raw
Agricultural Commodities Following Applications of a Glyphosate-Based
Formulation 2010 Canadian Trials. Monsanto Study Number: REG-10-026,
Report# MSL0022986. Unpublished study prepared by Monsanto, 167 pages.

Proposed Re-evaluation Decision – PRVD2015-01
Page 285

 References

2025590

2011, Magnitude of Glyphosate Residues in Glyphosate Tolerant Canola Raw
Agricultural Commodities Following Applications of a Glyphosate-Based
Formulation. Monsanto Study Number: REG-09-091, Report# MSL0022984.
Unpublished study prepared by Monsanto, 278 pages.

1924480

2009, Magnitude of Glyphosate Residues in corn Raw Agricultural
Commodities Following Topical Application of a Glyphosate Based
Formulation to Roundup Hybridization System (RHS) Seed Corn. US 2008
Trials, (MRID# 47982201) DACO: 7.2,7.4.1,7.4.2,7.4.6
2011, MSL 22984 Magnitude of Glyphosate Residues Following Topical
Application of a Glyphosate Based Formulation, (MRID# 48358101 ) DACO:
7.2,7.4.1
2011, MSL 22985 Magnitude of Glyphosate Residues Following Topical
Application of a Glyphosate Based Formulation, (MRID# 48358102 ) DACO:
7.2,7.4.1
2011, MSL 22986 Magnitude of Glyphosate Residues Following Topical
Application of a Glyphosate Based Formulation, (MRID# 48358103) DACO:
7.2,7.4.1
2010, THE METABOLISM OF [14C]GLYPHOSATE IN 0827 CANOLA,
(MRID# 48398601) DACO: 6.3
2010, Magnitude and Decline of Glyphosate Related REsidues in Forage and
Seed Genetically Modified Canola Event DP-073496-4 and Magnitude of
Glyphosate Related Residues in Canola Event DP-073496-4 Seed Process
Fractions Following Applications of Touchdown (MRID# 48398602).
USEPA Memo: Data waivers and cross references for Livestock Metabolism,
Enforcement Analytical Methodology and Multi-Residue Methodology
Evaluation, 11/26/12.

2025590

2025582

2025588

2013875
2006674 &
2006677

2256167

2256173
2256174
2256184

2256185
2256186
2256186
2256188

2256189

2008, DER for Glyphosate Summary of Analytical Chemistry and Residue
Data, DACO: 12.5.3,12.5.7
1997, Nature of Glyphosate Residues in Cotton Plants (Genotype Line #1445)
Tolerant to Roundup Herbicide, Report# MSL-14113.
1995, Validation of a New Residue Method for Analysis of Glyphosate and
Aminomethylphosphonic Acid (AMPA) - A Round-Robin Study, Report#
MSL-4268.
1991, Storage Stability of Glyphosate Residues in Crop Commodities, Report#
MSL-10843, 193 pages.
1995, Magnitude of Glyphosate Residues In Glyphosate-Tolerant Cotton Raw
Agricultural and Processed Commodities, , Report# MSL-13884.
1995, Magnitude of Glyphosate Residues In Glyphosate-Tolerant Cotton Raw
Agricultural and Processed Commodities, , Report# MSL-13884.
2003, Magnitude of Glyphosate Residues in Roundup Ready Flex Cotton Raw
Agricultural Commodities Following Topical Applications of a GlyphosateBased Formulation, Report# MSL-17635.
1974, Final Report on CP 67573, Residue and Metabolism Part 18:

Proposed Re-evaluation Decision – PRVD2015-01
Page 286

 References

2295151

2295155
2295157

Determination of Residues in Meat, Milk and Eggs, Report# 326.
Glyphosate in or on Cotton: Evaluation of Residue Data and Analytical
Methods, MRID# 435718, Barcodes D214931 & D214929. CBTS#s 15546 &
15547 7/31/95.
USEPA Memo: Dietary Exposure Analysis for Glyphosate in/on Sorghum,
3/10/03.
USEPA Memo: Glyphosate on Potatoes, Corn, Sorghum, Grapes, Plums/Prunes,
Sugar Beets, and Peanuts; Impact of Craven Analytical Data on Registrations,
10/21/91.

2295162

USEPA Memo: Glyphosate: Residue Data on Plums, Grapes and sugar Beets;
Replacement of Craven-Data by Monsanto Submission containing Reanalyses
of Stored Samples, 11/17/94.

2295163
2332518

USEPA Memo: Glyphosate in or on Cotton, 8/31/95.
2012, Metabolism of Glyphosate in GlyTol™ Canola Containing the 2mEPSPS
Expressing Gene, Bayer CropScience AG, Report # MEF-12/1056.
USEPA Memo, D200041, 5/12/94.
2009, Toxicokinetics of glyphosate and its metabolite aminomethyl phosphonic
acid in rats, DACO: 4.8
1987, An evaluation of the genotoxic potential of glyphosate, DACO 4.8
1992, NTP technical report on toxicity studies of glyphosate administered in
dosed feed to F344/N rats and B6C3F1 mice, DACO 4.8
2004, Pesticide residues in food – 2004 – joint FAO/WHO meeting on pesticide
residues – part II, DACO: 12.5.4
2009, Reasoned opinion – modification of the residue definition of glyphosate
in genetically modified maize grain and soybeans, and in products of animal
origin – summary, DACO: 12.5.4
2012, Evaluation of developmental toxicity studies of glyphosate with attention
to cardiovascular development, DACO: 12.5.4
2005, Cancer incidence among glyphosate-exposed pesticide applicators in the
agricultural health study, DACO: 12.5.4
USEPA Memo, Glyphosate Registration Review Scoping Document, DP#
D362745, 6/3/09.
USEPA Memo, DP# 321992, 9/29/06.

2443651
2391577
2391578
2391579
2391580
2391581

2391582
2391583
2443648
2443653

ADDITIONAL PUBLISHED INFORMATION
PMRA
Document
Number
2443642
2443643

Reference

AIR2 Project: Renewal of the Inclusion of Active Substances in Annex I to
Council Directive 91/414/EEC, Regulatory Update 14/2011 Issued 07 April 2011.
European Commission, Health & Consumer Protection Directorate: Glyphosate,
6511/VI/99-final, 1/21/02.

Proposed Re-evaluation Decision – PRVD2015-01
Page 287

 References

2443644

European Food Safety Authority (EFSA); Modification of the residue definition of
glyphosate in genetically modified maize grain and soybeans, and in products of
animal origin, EFSA Journal 2009; 7(9):1310.

2443646
2443647
2443650
2443645

US Federal Register, Vol. 72, No. 22, February 2, 2007.
US Federal Register, Vol. 78, No. 84, May 1, 2013.
USEPA Glyphosate Registration Review Summary Document.
Shaner, D. L. (2000) The impact of glyphosate-tolerant crops on the use of other
herbicides and on resistance management, Pest Manag. Sci. 56, 320-326.

E.

Studies Considered for the Environmental Risk Assessment

LIST OF STUDIES/INFORMATION SUBMITTED BY REGISTRANT
PMRA
Document
Number
1126906

1142749

1142750

1142751
1142752

1142753
1142754
1142755
1142756

1142757

Reference

Determination of the sorption & desorption properties of AMPA (MSL-12703;
206300; 252.0192.6135.710; 92-8-4390; 92-63-m8) final report (glyphosate), DACO:
8.2.4.1
Soil dissipation of alachlor, glyphosate, paraquat, simazine, cyanazine, atrazine and
metribuzin following tank-mix applications under laboratory conditions (RD597;4612;
MSL2073;7124), DACO: 8.2.4.1
Soil dissipation of alachlor, glyphosate, paraquat, linuron, maloran and diuron
following tank-mix applications under laboratory conditions (RD597; 4612;
MSL2118;7124), DACO: 8.2.4.1
Soil dissipation of alachlor, glyphosate and dynap following tank-mix applications
under laboratory conditions (RD597; 4612; MSL2126; 7124), DACO: 8.2.4.1
Dissipation of glyphosate in field soils following minimum till application of roundup
alone or in tank mix combinations with lasso me, atrazine, dyanap or metribuzin
(RD597;4612;MSL-2422;7124), DACO: 8.2.4.1
Aerobic metabolism of [14C] glyphosate in sandy loam and silt loam soils with
biometer flask (rd1031; PTRL1301; 368), DACO: 8.2.3.1
Aerobic aquatic metabolism of [14C] glyphosate (RD1030;MSL-10576; PTRL366),
DACO: 8.2.3.1
Anaerobic aquatic metabolism of [14C] glyphosate (RD1029; PTRL367), DACO:
8.2.3.1
Persistence and dissipation of glyphosate in foliage and soils of a Canadian coastal
watershed. J. Feng and D. Thompson. Proceedings of the carnation creek herbicide
workshop. March,1989.(frda063; issn08350752; pages# 65-81), DACO: 8.3.2.3
Fate of glyphosate and its influence on nitrogen-cycling in two Finnish agriculture
soils. M. Muller et.al. Bull. Environm. Contam. toxicol. (pages# 724-730) +
Persistence, movement and degradation of glyphosate in selected Canadian boreal

Proposed Re-evaluation Decision – PRVD2015-01
Page 288

 References

1142758
1142761
1142762
1142763
1142764
1142765

1142766

1142767
1142768

1142769

1142770
1142771
1142773
1155370
1155371
1155372
1155375
1155377

forest soils. D. Roy et.al. J. Agric. Food Chem. (pages# 437-440), DACO: 8.3.2.3
Dissipation of glyphosate in U.S. field soils following direct application of roundup
herbicide (RD696; MSL-5901;MSL-3210;7163), DACO: 8.3.2.3
Dissipation of glyphosate in U.S. field soils following multiple applications of
roundup herbicide (RD697;MSL-5902;MSL-3352;7163), DACO: 8.3.2.3
Roundup herbicide dissipation in cool climate forest soil and leaf litter (RD697;MSL5902;MSL-2950;7163), DACO: 8.3.2.3
Dissipation of glyphosate and aminomethylphosphonic acid in forestry sites
(RD993;MSL-9940), DACO: 8.3.2.3
Rapid dissipation of glyphosate in small forest ponds, DACO: 8.3.3.3
Behaviour of glyphosate in the aquatic environment. J. Bronstad and H. Friestad.
Agricultural university of Norway, as-NLH, Norway. Chapter 13. (pages#200-205),
DACO: 8.3.3.3
Aquatic dissipation of glyphosate and Ampa in water and soil sediment following
application of glyphosate in irrigated crop and forestry uses (RD898;MSL8332;066300)(cont’d on roll#1014), DACO: 8.3.3.3
Photodegradation and anaerobic aquatic metabolism of glyphosate, N-phosphonomethylglycine final report (RD924;MSL-0598;7863), DACO: 8.2.1,8.2.3.1
Addendum to MSL-3210-Dissipation of glyphosate in U.S. field soils following direct
application of roundup herbicide final report (RD924; MSL-8081;066335), DACO:
8.3.2.3
Solubility, volatility, adsorption and partition coefficients, leaching and aquatic
metabolism of MON 0573 and MON 0101 final report (RD181; MSL-0207;7863),
DACO: 8.2.1,8.2.3.1,8.2.4.1
Photodegradation of 14C glyphosate in buffered aqueous solution at pH 5,7 and 9 by
natural sunlight (RD 1020; MSL-10575;PTRL 233W-1), DACO: 8.2.1
Photodegradation of 14C glyphosate in/on soil by natural sunlight (RD972;
MSL-9271;PTRL-153W), DACO: 8.2.1
Soil dissipation of Roundup, Lasso and Simazine herbicides (RD597; 4612; MSL0064;7163), DACO: 8.2.4.1
Persistence, movement and degradation of glyphosate in selected Canadian boreal
forest soils (RESID008; 437-440) Roy, Prasad et.al. (Roundup), DACO: 8.3.2.3
Fate of glyphosate in an Oregon forest ecosystem (ENVIR004; c1144-1151) Newton,
Dubelman et.al. Journal of Agr. and Food Chemistry (Roundup), DACO: 8.3.2.3
Rapid dissipation of glyphosate in small forest ponds (AQUAT005;537-544)
Goldsborough/Beck, Arch. Environ. Contam. toxicol. (roundup), DACO: 8.3.3.3
Fate of glyphosate in a Canadian forest watershed.2. Persistence in foliage and soils
(RESID009;1118-1125) Feng/Thompson (Roundup), DACO: 8.3.2.3
Measurement of the environmental effects associated with forestry use of Roundup.
Environment Canada Conservation and Protection environmental protection.
Ernst/Hennigar et.al. (Ep-5-Ar-87-8;ENVIR006), DACO: 8.3.2.3

Proposed Re-evaluation Decision – PRVD2015-01
Page 289

 References

1161810
1161812
1161813
1161822
1161827
1161828
1161829
1182629

1184806
1184843
1184953
1202044
1202045
1202047
1213211
1213212
1213213
1213214
1213217
1213218
1213219

(14C)-glyphosate: adsorption/desorption in soil. Final report.(676/3;7180)., DACO:
8.2.4.2
Leaching characteristics of formulated 14C-glyphosate in three soils. (281430).
DACO: 8.2.4.4
Degradation and metabolism of 14C-glyphosate in soil incubated under aerobic
conditions.(246486)., DACO: 8.2.3.4.2
Determination of the degradability and persistence of 14C-glyphosate in the
water/sediment-system.(ET01SE01)., DACO: 8.2.3.5.2,8.3.3.3
Hydrolysis determination of 14C-glyphosate (pmg) at different pH values. + First
amendment to Report.(238500)., DACO: 8.2.3.2
Photodegradation study of 14C -glyphosate on soil. + protocol.(315764)., DACO:
8.2.3.3.1
Photodegradation study of 14C -glyphosate in water at pH 5, 7 and 9.(250751).,
DACO: 8.2.3.3.2
1981, Roundup herbicide forest ecosystem study; part I: residues of glyphosate,
amino-methylphosphonic acid and N-nitrosoglyphosate in forest soil and water
following aerial application of Roundup herbicide. Final report. Date: March, 1981.
Monsanto Canada inc. (MSL-1578; 7163). (PCP#13644 Environmental Chemistry
volume 1 of 1), DACO: 8.3.2.2
MON-0573, residue and metabolism. Part 2: the photolysis, run-off, and leaching of
MON-0573 on or in soil. DACO: 8.2.3.3.1,8.2.4.3.1
1982, Additional information to support the registration of roundup herbicide-forest
ecosystem study; part II. DACO: 8.3.4
Final report on MON-0573, RESIDue and metabolism, part 2: the photolysis, run-off,
and leaching of Mon-0573 on or in soil. DACO: 8.2.4.3.1
G-3780A Surfactant: biodegradation in natural waters, DACO: 8.3.3.3
G-3780A Surfactant: biodegradation, plant uptake & 14C-dist’n, DACO: 8.3.4
Environmental fate of the polyethoxylated tallow amine surfactant with 20 ethylene
oxide units, DACO: 8.3.4
1996, [P-Methylene-14C] Glyphosate Acid: Aqueous Hydrolysis at pH 5, 7, and 9 and
25oC (WRC-96-003) (WINO 17973), DACO: 8.2.3.2
1996, [P-Methylene-14C] Glyphosate Acid: Photodegradation in/on Soil by Natural
Sunlight, DACO: 8.2.3.3.1
1996, [P-Methylene-14C] Glyphosate Acid: Photodegradation in a Buffered Aqueous
Solution at pH 5 and 7 by Natural Sunlight, DACO: 8.2.3.3.2
1996, [P-Methylene-14C] Glyphosate Acid: Aerobic Soil Metabolism, DACO:
8.2.3.4.2
2005, Note to the Reviewer: Glyphosate Phototransformation in Air, DACO: 8.2.3.3.3
1996, Glyphosate Acid: Adsorption and Desorption Properties in 5 Soils, DACO:
8.2.4.2
1996, Glyphosate Acid: Adsorption and Desorption Properties of the Major
Metabolite, AMPA, in Soil, DACO: 8.2.4.2

Proposed Re-evaluation Decision – PRVD2015-01
Page 290

 References

1224531

1226906
1311111
1311112
1311129
1311130
1311131
1401896
1401897
1403269
1726638
1726642
1971119
2032017

2005, Glyphosate Acid: residue Levels in Soil After Application to Turf and to Bare
Soil for Trials Conducted in California during 1995-1996 (WRC-98-112) (WINO
17976), DACO: 8.3.2
Leaching characteristics of aged CGA-12223 (1254), DACO: 8.2.4.1
2005, Environment Canada, unpublished pesticide science fund annual report 20042005. (water, air, plants, mammals and amphibians; and fish and birds.) DACO: 8.6
2004, Environment Canada, unpublished national water monitoring data. pesticide
science fund (2004)., DACO: 8.6
2004, Manitoba water stewardship, unpublished water monitoring data from Manitoba
(1991 - 2001), DACO: 8.6
2002, Manitoba conservation, Manitoba conservation (2002) unpublished water
monitoring data collected in Manitoba (1990 - 2001), DACO: 8.6
2004, Manitoba water stewardship, unpublished water monitoring data from Manitoba
(2001 - 2003), DACO: 8.6
2001, Urban Pesticide Monitoring Data - 2001.[Containing data on pesticide
concentrations in eight Canadian tributaries of Lake Ontario.], DACO: 8.6
2001, Urban Pesticide Monitoring Data - 2000.[Containing data on pesticide
concentrations in eight Canadian tributaries of Lake Ontario.], DACO: 8.6
2006, Environment Canada, pesticide science fund annual report 2005-2006., DACO:
8.6
Pesticide Science Fund Annual Report 2006-2007
DACO: 8.6, 9.9, DACO: 8.6,9.9
Pesticide Science Fund Annual Report 2007-2008
DACO 8.6, 9.9, DACO: 8.6,9.9
2010, Raw Unpublished Pesticide Science Fund Water Monitoring from Mill Creek
British Columbia, DACO: 8.6
2011, A Summary of Relevant Existing Information on the Aquatic Toxicity of
Glyphosate Acid, Glyphosate Salts, Glyphosate-based Formulations and Formulation
Components to Amphibians and Fish, DACO: 9.9

2035772

Pesticides dans l’eau de surface d’une zone maraîchère Ruisseau Gibeault-Delisle dans
les « terres noires » du bassin versant de la rivière Châteauguay de 2005 à 2007 Juin
2010, DACO: 8.6

2104739

2011, Evaluation of the Potential for Chronic Exposure to and Chronic Effects from
Glyphosate Formulations, DACO: 9.9

2170903

PEI Department of Environment, Energy and forestry. (2010). Summary of Statistics
from the PEI Groundwater Monitoring Program (2004 à 2009), notes from 2008 and
the analyte list from 2009., DACO: 8.6
Ontario Ministry of the Environment. (2010). Unpublished groundwater monitoring
data from Ontario’s Provincial Groundwater Monitoring Network. Received
September 2011., DACO: 8.6
2013, Comparative toxicity of Glyphosate-Based Herbicides: Aqueous and Sediment
Porewater Exposures - Report prepared for: National Contaminants Advisory Group,
Ecosystem Science, Fisheries and Oceans Canada, DACO: 8.6,9.9

2171036

2469837

Proposed Re-evaluation Decision – PRVD2015-01
Page 291

 References

2469838

790009
790011
790012
790013
1126861

1142775
1142776
1142777
1142778
1142779

2013, Report 3: Preliminary Results and interpretations - Report prepared for: National
Contaminants Advisory Group, Ecosystem Science, Fisheries and Oceans Canada,
DACO: 8.2.3.5.4
2002, MON 2139: Lemna minor growth inhibition test, DACO: 9.8.6
2002, MON 78087 21 day toxicity test with the sedge, Carex comosa, DACO: 9.8.6
2002, MON 78087 21 day toxicity test with the pickerel weed, Pontederia cordata,
DACO: 9.8.6
2002, MON 78087 21 day toxicity test with the pond lily, Nymphea odorata, DACO:
9.8.6
1991, Acute toxicity study of AMPA in rainbow trout. Final report (AB-90-402;
38987;MSL-10855;ML-90-403/EHL90187; Final raw data report# 38987R).
(Glyphosate), DACO: 9.5.2.1
The toxicity of glyphosate technical to Selenastrum capricornutum (1092-02-11001;AABT-SEL-06;RD779), DACO: 9.8.2
The toxicity of glyphosate technical to Navicula pelliculosa (1092-02-1100-2;AABTNAP-02;RD780), DACO: 9.8.2
The toxicity of glyphosate technical to Skeletonema costatum (1092-02-11003;AABT-SKL-04;RD781), DACO: 9.8.3
The toxicity of glyphosate technical to Anabaena flos-aquae (1092-02-1100-4;AABTANA-04;RD782), DACO: 9.8.2
The toxicity of glyphosate technical to Lemna gibba (1092-02-1100-5;PLSA-LEM5;RD783), DACO: 9.8.2

1142807

1991, Acute toxicity of AMPA to Daphia magna. Final report, DACO: 9.3.1

1145595

An investigation of the toxicity of the technical material and soluble concentrate
formulation 4LC-E (YF7712) to adult female Daphnia magna
(RJ0679B;88JH299)(GLYPHOSATE), DACO: 9.3.1
Glyphosate technical: acute oral toxicity (ld50) to the bobwhite quail. (CHV48/91266;
58113), DACO: 9.6.2.1
Acute toxicity (LC50) study of glyphosate to earthworms.(250784), DACO: 9.2.3.1
Acute toxicity (LC50) study of glyphosate 360 to earthworms. (271664). (*note- no
page#13 was included in this study), DACO: 9.2.3.1
48-Hour acute toxicity of glyphosate technical to Daphnia magna (OECDimmobilization test). (272968)., DACO: 9.3.1
48-Hour acute toxicity of glyphosate 360 to Daphnia magna (OECD-immobilization
test).(272970)., DACO: 9.3.1
Glyphosate technical acute oral toxicity (ld50) to mallard duck (Anas
platyrhynchos).(CHV49/91843)., DACO: 9.6.2.1
Influence of glyphosate 360 on the reproduction of Daphnia magna. (271697), DACO:
9.3.1
Influence of glyphosate on the reproduction of Daphnia magna. (250795)., DACO:
9.3.1
Acute Toxicity of Glyphosate 360 to Scenedesmus Subspicatus (OECD- Algae Growth
Inhibition Test).(271675)., DACO: 9.8.2

1161830
1161834
1161835
1161839
1161840
1161841
1161842
1161843
1161844

Proposed Re-evaluation Decision – PRVD2015-01
Page 292

 References

1161845
1161847
1161848

1161854
1161866
1161867
1161868
1161869
1161870
1164974

1164975

1164982

Acute toxicity of glyphosate to Scenedesmus subspicatus (OECD- Algae growth
inhibition test).(250773)., DACO: 9.8.2
LX1146-02 (Glyphosate technical) tier II non-target plant hazard evaluation-terrestrial
vegetative vigor.(14625B018;1231-92-146-02-25B-16)., DACO: 9.8.4
Glyphosate technical tier II non-target plant hazard evaluation-terrestrial seed
germination and seedling emergence.(14625B017;1231-92-146-02-25B-15)., DACO:
9.8.4
Glyphosate technical: 96-hour acute toxicity study (LC50) in the bluegill
sunfish.(271642)., DACO: 9.5.2.1
Glyphosate 360: 96-hour acute toxicity study (LC50) in the bluegill sunfish. (271710).,
DACO: 9.5.2.1
Glyphosate 360: 96-hour acute toxicity study (LC50) in the rainbow trout.(271708).,
DACO: 9.5.2.1
Glyphosate technical: 96-hour acute toxicity study (LC50) in the rainbow
trout.(271631)., DACO: 9.5.2.1
Glyphosate technical: 21-day prolonged toxicity study in the rainbow trout under flowthrough conditions.(271620)., DACO: 9.5.3.1
Glyphosate 360: 21-day prolonged toxicity study in the rainbow trout under flowthrough conditions.(271686)., DACO: 9.5.3.1
Toxicity of Glyphosate Technical to Aquatic Plant Organisms (Algae & Lemna).
October,1987. Sub. Date: 96.02.16.(Selenastrum Capricornutum, Navicula Pelliculosa,
Skeletonema Costatum, Anabaena Flos-Aquae, Lemna Gibba) (RD779-783;1092-021100-1;1092-02-1100-2;1092-02-1100-3; 1092-02-1100-4;1092-02-1100-5)., DACO:
9.8.2,9.8.3,9.8.5
An evaluation of the preemergence herbicidal activity of CP-70139. March, 1987.
Submission date: February 16, 1996. (RD767;MSL-6574; 056337). (Roundup),
DACO: 9.8.4
Tier 2 vegetative vigour non-target plant phytotoxicity study using glyphosate.
(RD1219; 93235; MSL-13320). (Roundup), DACO: 9.8.4

1182523

Four-day static fish toxicity studies with CP67573 in rainbow trout and bluegills.
DACO: 9.5.2.1,9.5.2.2

1182525

Four-Day Static Fish Toxicity Studies With MON2139 Formulation in Rainbow Trout
and Bluegills. DACO: 9.5.2.1,9.5.2.2
Four-day static fish toxicity study with CP67573 in carp. DACO: 9.5.2.2

1182526
1182527

Exposure of fish to 14C-Roundup: accumulation, distribution, and elimination of 14Cresidues. DACO: 9.5.6

1182528

Eight-day dietary LC50-bobwhite quail. Technical CP67573. DACO: 9.6.2.4

1182532

The acute contact and oral toxicities OF CP67573 and MON2139 to worker honey
bees. DACO: 9.2.4.1,9.2.4.2

1182533

The acute toxicity of MON2139 to Daphnia. DACO: 9.3.2

Proposed Re-evaluation Decision – PRVD2015-01
Page 293

 References

1182534

Acute toxicity of roundup (technical) to atlantic oyster (Crassostrea virginica). DACO:
9.4.2

1182535

Acute toxicity of roundup (technical) to grass shrimp (Palaemonetes vulgaris) and
fiddler crab (Uca pagilator). DACO: 9.4.2

1182536

Acute toxicity of roundup to bluegill (Lepomis Macrochirus). DACO: 9.5.2.2

1182538

1978, One-generation reproduction study-mallard duck. Glyphosate technical. Final
report. (139-143). [Glyphosate;r.d.#211; special report# MSL-0577; 235924], DACO:
9.6.3.2
1978, One-generation reproduction study-bobwhite quail. Glyphosate technical. Final
report [Glyphosate; submitted: November 13,1978; R.D.#211; special report# MSL0577;235924], DACO: 9.6.3.1
1980, Acute toxicity of roundup to the water flea (Daphnia magna) [glyphosate;
R.D.#350; special report# MSL-1548], DACO: 9.3.2

1182539

1182542
1182543

1980, Acute toxicity of roundup to channel catfish (Ictalurus punctatus) [glyphosate;
R.D.#350; special report# MSL-1548], DACO: 9.5.2.2

1182544

1980, Acute Toxicity of Roundup to Rainbow Trout (Salmo Gairdneri).
[Glyphosate;R.D.# 350;Special Report# MSL-1548], DACO: 9.5.2.1

1182545

1980, Acute toxicity of roundup to fathead minnow (Pimephales promelas).
[glyphosate; R.D.#350; special report# MSL-1548], DACO: 9.5.2.1

1182546

1980, Acute toxicity of roundup to bluegill (Lepomis macrochirus) [glyphosate,
r.d.#350;special report#MSL-1548], DACO: 9.5.2.2

1182547

Information to support the use of roundup (EPA 524-308) for weed control on or
around aquatic sites and data in support of tolerance requests for glyphosate in potable
water, fish and shellfish. DACO: 9.4.2,9.5.2.1
Combined data submission: application for an experimental use permit for Roundup
(EPA reg.no.524-308) and petition for temporary tolerances for glyphosate in aquatic
weed control. DACO: 9.5.5
Dynamic 96-hour acute toxicity of roundup to bluegill sunfish (Lepomis macrochirus).
DACO: 9.5.2.2
Dynamic 96-hour acute toxicity of roundup to rainbow trout (Salmo gairdneri). DACO:
9.5.2.1

1182548

1182549
1182550
1182559

Dynamic 48-Hour Acute toxicity of Roundup to Grammarus Pseudolimnaeus. DACO:
9.3.2

1182570

Chronic toxicity of Glyphosate to Daphnia Magna Under Flow-Through Test
Conditions. DACO: 9.3.3

1184692

Four-Day Static Fish Toxicity Studies With Mon2139 Formulation in Rainbow Trout
and Bluegills. DACO: 9.5.2.1,9.5.2.2

Proposed Re-evaluation Decision – PRVD2015-01
Page 294

 References

1184694
1184697

Four-Day Static Fish Toxicity Studies With CP67573 in Rainbow Trout and Bluegills.
DACO: 9.5.2.1, 9.5.2.2
Four-Day Static Fish Toxicity Study With CP67573 in Carp. DACO: 9.5.2.2

1184732

Dynamic 96-Hour Acute Toxicity of Roundup to Bluegill Sunfish (Lepomis
Macrochirus). DACO: 9.5.2.2

1184732

Dynamic 96-Hour Acute Toxicity of Roundup to Bluegill Sunfish (Lepomis
Macrochirus). DACO: 9.5.2.2

1184733

Dynamic 96-Hour Acute toxicity of Roundup to Rainbow Trout (Salmo Gairdneri).
DACO: 9.5.2.1

1184734

Dynamic 48-Hour Acute Toxicity of Roundup To Gammarus Pseudolimnaeus. DACO:
9.3.2
Chronic Toxicity of Glyphosate to Daphnia magna Under Flow-Through Test
Conditions. DACO: 9.3.3

1184735

1184737

Four-Day Static Fish Toxicity Study With Roundup in Carp. DACO: 9.5.2.2

1184740

Four-Day Static Fish toxicity Study with MON2139 in Channel Catfish. DACO:
9.5.2.2
The Acute toxicity of Glyphosate to Harlequin Fish (Rasbora Heteromorpha). DACO:
9.5.2.3

1184764
1184765

Four-Day Static Aquatic toxicity Study With MON2139 in Crayfish. DACO: 9.4.2

1184768

One-Generation Reproduction Study-Mallard Duck. Glyphosate. DACO: 9.6.3.2

1184798

The Acute Contact and Oral toxicities of CP67573 and MON2139 to Worker Honey
Bees. DACO: 9.2.4.1,9.2.4.2

1184830

Four-Day Static Fish toxicity Studies With CP67573 in Rainbow Trout and Bluegills.
DACO: 9.5.2.1,9.5.2.2

1184831

Four-Day Static Fish toxicity Studies With MON2139 formulation in Rainbow Trout
and Bluegills. DACO: 9.5.2.1,9.5.2.2

1184937

Four-Day Static Fish Toxicity Studies With CP67573 in Rainbow Trout and Bluegills.
DACO: 9.5.2.1,9.5.2.2

1184939

Four-Day Static Fish Toxicity Studies With MON2139 Formulation in Rainbow Trout
and Bluegills. DACO: 9.5.2.1,9.5.2.2

1184940

Four-Day Static Fish Toxicity Study With CP67573 in Carp. DACO: 9.5.2.2

1184941

Exposure of Fish to 14C-Roundup: Accumulation, Distribution, and Elimination of
14C-Residues. DACO: 9.5.4

1184942

Eight-Day Dietary LC50-Bobwhite Quail. Technical CP67573. DACO: 9.6.2.4

Proposed Re-evaluation Decision – PRVD2015-01
Page 295

 References

1184947

The Acute Toxicity of MON2139 to Daphnia. DACO: 9.3.2

1184948

Acute Toxicity of Roundup (Technical) to Atlantic Oyster (Crassostrea virginica).
DACO: 9.4.2

1184949

Acute Toxicity of Roundup (Technical) to Grass Shrimp (Palaemonetes vulgaris) and
Fiddler Crab (Uca pagilator). DACO: 9.4.2

1184950
1193116

Acute Toxicity of Roundup to Bluegill (Lepomis macrochirus). DACO: 9.5.2.2
Summary And Final Report, MON 58121: A 48-Hour Flow-Through Acute toxicity
Test With The Cladoceran (Daphnia Magna), DACO: 9.3.1,9.3.2

1193128

Summary and Final Report, MON 58121: A 96-Hour Flow-Through Acute toxicity
Test With the Rainbow Trout (Oncorhynchus Mykiss). DACO: 9.5.1,9.5.2.1

1193139

Summary and Report, Mon 58121: an Acute Oral toxicity Study with the Northern
Bobwhite, DACO: 9.6.1,9.6.2.1

1193140

Summary and Report, MON 58121: A Dietary LC50 Study With the Northern
Bobwhite. DACO: 9.6.1,9.6.2.4

1205293

1986, Acute toxicity of roundup herbicide to chinook salmon, DACO: 9.5.2.1

1205294

1986, Acute Toxicity of Roundup Herbicide to Coho Salmon, DACO: 9.5.2.1

1205295

1986, Acute toxicity of roundup herbicide to rainbow trout, DACO: 9.5.2.1

1213224

1999, Glyphosate-potassium: toxicity of an SL formulation to the Earthworm Eisenia
fetida in an Artificial Soil Test, DACO: 9.2.3.1

1213225

2000, Glyphosate Acid: A Laboratory investigation of the Effects of Glyphosate and its
Breakdown Product AMPA on Reproduction in the Earthworm Eisenia fetida, DACO:
9.2.3.1
2000, AMPA: Acute toxicity of AMPA Technical Material to the Earthworm Eisenia
andrei in an Artificial Soil Test, DACO: 9.2.3.1

1213226

1213227

1998, Glyphosate Acid: Acute Contact and Oral toxicity to Honey Bees (Apis
mellifera), DACO: 9.2.4.1

1213228

1999, Amended report - Glyphosate Acid: Acute Contact and Oral toxicity to Honey
Bees (Apis mellifera) of an SL formulation, DACO: 9.2.4.1

1213229

2000, Glyphosate: A Tier I Laboratory Study to Evaluate the Effects of an SL
formulation on the Predatory Mite, Typhlodromus pyri (Acarina, Phytoseiidae),
DACO: 9.2.5

Proposed Re-evaluation Decision – PRVD2015-01
Page 296

 References

1213230

1213231

1213232

1213233

1213234

1213235

1213236

2000, Glyphosate: A Tier II Extended Laboratory Study to Evaluate the Effects of an
SL formulation on the Predatory Mite, Typhlodromus pyri (Acarina, Phytoseiidae),
DACO: 9.2.5
2000, Glyphosate: A Tier I Laboratory Study to Evaluate the Effects of a SL
formulation on the Carabid Beetle Poecilus cupreus (Coleoptera: Carabidae), DACO:
9.2.5
2001, Glyphosate : A Tier II Laboratory Study to Evaluate the Effect of a SL
formulation on the Staphylinid Beetle, Aleochara bilineata Gyll. (Coleoptera,
Staphylinidae), DACO: 9.2.5
2000, Glyphosate: A Tier I Laboratory Study to Evaluate the Effects of an SL
formulation on the Green Lacewing, Chrysoperla carnea (Neuroptera, Chrysopidae),
DACO: 9.2.5
2000, Glyphosate: A Tier I Laboratory Study to Evaluate the Effects of an SL
formulation on the Parasitic Wasp, Aphidius rhopalosiphi (Hymenoptera, Braconidae),
DACO: 9.2.6
2000, Glyphosate : A Tier II Extended Laboratory Study to Evaluate the Effects of an
SL formulation on the Parastic Wasp, Aphidius rhopalosiphi (Hymenoptera,
Braconidae), DACO: 9.2.6
2001, Glyphosate: A Tier II Laboratory Study to Evaluate the Effect of a SL
formulation on the Hoverfly Episyrphus balteatus (Diptera: syrphidae), DACO: 9.2.6

1213237

1995, Glyphosate Acid: Acute toxicity to Daphnia magna, DACO: 9.3.2

1213238

1993, AMPA- Acute toxicity to Daphnia magna, DACO: 9.3.2

1213239

1998, Glyphosate Acid: Chronic toxicity to Daphnia magna, DACO: 9.3.3

1213240

1996, Glyphosate Acid: Acute toxicity to Mysid Shrimp (Mysidopsis bahia), DACO:
9.4.2

1213241

1996, Glyphosate Acid: Acute toxicity to Larvae of the Pacific Oyster (Crassostrea
gigas), DACO: 9.4.3

1213242

1995, Glyphosate Acid: Acute toxicity to Rainbow Trout (Oncorhynchus mykiss),
DACO: 9.5.2.1

1213243

1993, AMPA- Acute toxicity to Rainbow Trout, DACO: 9.5.2.1

1213244

1995, Glyphosate Acid: Acute toxicity to Bluegill Sunfish (Lepomis macrochirus),
DACO: 9.5.2.2

1213245

2001, Glyphosate: Acute toxicity to Mirror Carp (Cyprinus carpio), DACO: 9.5.2.3

1213246

1996, Glyphosate Acid: Acute toxicity to Sheepshead Minnow (Cyprinodon
variegatus), DACO: 9.5.2.4

Proposed Re-evaluation Decision – PRVD2015-01
Page 297

 References

1213248

1997, Glyphosate Acid: Acute Oral toxicity (LD50) to Bobwhite Quail, DACO: 9.6.2.1

1213249

1997, Glyphosate Acid: Dietary LC50 to the Bobwhite Quail, DACO: 9.6.2.4

1213250

1997, Glyphosate Acid: Dietary LC50 to the Mallard Duck, DACO: 9.6.2.5

1213251

1999, Glyphosate Acid: A Reproduction Study with the Northern Bobwhite (Colinus
virginianus), DACO: 9.6.3.1

1213252

1999, Glyphosate Acid: A Reproduction Study with the Mallard (Anas platyrhynchos),
DACO: 9.6.3.2

1213253

1995, Glyphosate Acid: toxicity to the Green Alga (Selenastrum capricornutum),
DACO: 9.8.2

1213254

1996, Glyphosate Acid: toxicity to Blue-Green Alga (Anabaena flos-aquae), DACO:
9.8.2

1213255

1996, Glyphosate Acid: toxicity to the Freshwater Diatom Navicula pelliculosa,
DACO: 9.8.2

1213256

1994, AMPA: Testing of toxic Effects of Aminomethyl Phosphonic Acid (AMPA) on
the Single Cell Green Alga Scenedesmus subspicatus, DACO: 9.8.2

1213257

1999, Glyphosate: Toxicity to the Green Alga Selenastrum capricornutum of a 360g/L
SL Formulation, DACO: 9.8.2

1213258

1996, Glyphosate Acid: Toxicity to the Marine Alga Skeletonema costatum, DACO:
9.8.3

1213259

1996, Glyphosate Acid: A Tier II Glasshouse Study to assess the Effects on Seedling
Emergence of Terrestrial Non-target Plants, DACO: 9.8.4

1213260

1996, Glyphosate Acid: A Tier II Glasshouse Study to Assess the Effects on Vegetative
Vigour of Terrestrial Non-target Plants, DACO: 9.8.4

1213261

1996, Glyphosate Acid: toxicity to Duckweed (Lemna gibba), DACO: 9.8.5

1414963

2003, Acute toxicity of CHA 4521 to Daphnia magna in 48-Hour Immobilization Test.
Final Analytical Report to Acute toxicity of CHA 4521 to Daphnia magna in a 48-Hour
Immobilization Test, DACO: 9.3,9.3.1,9.3.5
2003, Acute toxicity of CHA 4521 to Rainbow Trout (Oncorhynchus mykiss) in a 96Hour Static Test. Final Analytical Report to: Acute toxicity of CHA 4521 to Rainbow
Trout (Oncorynchus mykiss) in a 96-Hour Static Test, DACO: 9.5,9.5.1,9.5.4

1414964

Proposed Re-evaluation Decision – PRVD2015-01
Page 298

 References

1414965

1415025

1415026

1415027

1883054
2020241

2032017

2134645

2000, CHA 4520, CHA 4521, and CHA 45EXT (SL formulations with Glyphosate) :
Alga, Growth inhibition Test with the Freshwater Algae Pseudokirchneriella
Subcapitata, DACO: 9.8,9.8.1,9.8.6
2003, Acute toxicity of CHA 4525 to Daphnia magna in a 48-Hour Immobilization
Test. Final Analytical Report to Acute toxicity of CHA 4525 to Daphnia magna in a
48-Hour Immobilization Test, DACO: 9.3,9.3.1,9.3.5
2003, Acute toxicity of CHA 4525 to Rainbow Trout (Oncorhynchus mykiss) in a 96Hour Static Test. Final Analytical Report to: Acute toxicity of CHA 4525 to Rainbow
Trout (Oncorhynchus mykiss) in a 96-Hour Static Test, DACO: 9.5,9.5.1,9.5.4
2003, toxicity of CHA 4525 to Pseudokirchneriella subcapitata in an Algal Growth
inhibition Test. Final Analytical Report to toxicity of CHA 4525 to Pseudokirchneriella
subcapitata in an Algal Growth inhibition Test, DACO: 9.8,9.8.1,9.8.6
1998, Effects of Sub-Lethal Rates of Roundup Herbicides on Green Ash, DACO: 9.8.7
2009, Biological Evaluation of the phytotoxicity of A12798QA - DiammoniumGlyphosate SL360 after soil Pre-Plant incorporation (PPI) and post emergence
application, DACO: 9.8.4
2011, A Summary of Relevant Existing information on the Aquatic toxicity of
Glyphosate Acid, Glyphosate Salts, Glyphosate-based formulations and formulation
Components to Amphibians and Fish, DACO: 9.9
2011, A 96-hour Flow-Through Shell Deposition Test with the Eastern Oyster, DACO:
9.4.4,9.4.6

2134650

2011, A 96-hour Static Acute toxicity Test with the Sheepshead Minnow, DACO:
9.5.2.4,9.5.4

2162228

2012, A 96-hour Static Acute toxicity Test with the Saltwater Mysid (Americamysis
bahia), DACO: 9.4.2,9.4.6

2162290

2012, Acute toxicity Test (Embryo-Larval) with Eastern Oyster (Crassostrea virginica)
Under Static Conditions, DACO: 9.4.3,9.4.6
2011, Wetland Habitat Quality Study - Potential Effects of Glyphosate Herbibicide
Applications on Forest Wetland and Amphibian Breeding Success - Annual Report MNR Competitive Research Programs, DACO: 9.9

2201993

2203572

2211852

2012, Acute toxicity of Thirty Four Pesticide formulations to Amphibians, Fish,
invertebrates, Bacteria, and Algae, and a Comparative Analysis of Their Relative
Sensitivity, DACO: 9.9
2012, Glyphosate SL (A13013M) - Evaluation of the Phytotoxicity to Non Target
Terrestrial Plant Vegetative Vigour Test, DACO: 9.8.4

2211858

2012, TK0060935, DACO: 9.8.4

2223076

2012, MON 2139: Acute toxicity Test (Embryo-Larval) with Eastern Oyster
(Crassostrea virginica), DACO: 9.4.3,9.4.6

Proposed Re-evaluation Decision – PRVD2015-01
Page 299

 References

2223078
2469799

2012, MON 2139: A 96-Hour Static Acute toxicity Test with the Sheepshead Minnow
(Cyprinodon variegatus), DACO: 9.5.2.4,9.5.4
2012, Effets des pesticides de la vigne sur le cycle biologique de l’escargot dans divers
contextes d’exposition - , DACO: 9.2.7,9.3.4

2469803

2007, EPA DER of Bowman, J.H. 1991. Acute toxicity of AMPA to rainbow trout
(Oncorhynchus mykiss) - EPA DER 43334713, DACO: 9.5.2.1

2469813

2013, Assessment of herbicide effect on terrestrial plants and habitats in
agroecosystems - Final report submitted to the Pest Management regulatory Agency
(Health Canada), DACO: 9.8.1
2012, Glyphosate: An Acute Oral toxicity Study with the Canary (Serinus canaria),
DACO: 9.6.2.3

2469823
2469824

2012, MON 2139: a 96-Hour Shell Deposition Test with the Eastern Oyster
(Crassostrea virginica), DACO: 9.4.4

2469825

2012, MON 2139: A 96-hour flow-through acute toxicity test with the white shrimp
(Litopenaeous vannamei), DACO: 9.4.4

2469826

2012, MON 2139: A 96-hour static acute toxicity test with the saltwater mysid
(Americamysis bahia), DACO: 9.4.2

ADDITIONAL INFORMATION CONSIDERED
Published Information
1307571
Giroux, i., 2002, Ministère de l’environnement, direction des écosystèmes aquatiques,
contamination de l’eau par les pesticides dans les régions de culture de maïs et de soya
au Québec; résultats des campagnes d’échantillonnage 1999, 2000 et 2001 et évolution
temporelle de 1992 à 2001., envirodoq env/2002/0365, qe/137 , DACO: 8.6
1311118
Anderson Anne-Marie, 2005, Alberta environment; Environmental monitoring and
evaluation branch, Overview of pesticide data in Alberta surface waters since 1995,
http://www3.gov.ab.ca/env/info/infocentre/publist.cfm DACO: 8.6
1398451
Giroux, I. et al, 2006, Ministère du Développement durable, de l’Environnement et des
Parcs, Direction du suivi de l’état de l’environnement, Direction des politiques de
l’eau et Centre d’expertise en analyse environnementale du Québec., Part 1: La
présence de pesticides dans l’eau au Québec, Bilan dans les cours d’eau de zones en
culture de maïs et de soya en 2002, 2003 et 2004 et dans les réseaux de distribution
d’eau potable., http://www.mddep.gouv.qc.ca/pesticides/mais_soya/index.htm DACO: 8.6
1398452
Giroux, I. et al, 2006, Part 2: La présence de pesticides dans l’eau au Québec, Bilan
dans les cours d’eau de zones en culture de maïs et de soya en 2002, 2003 et 2004 et
dans les réseaux de distribution d’eau potable. Ministère du Développement durable,
de l’Environnement et des Parcs, Direction du suivi de l’état de l’environnement,
Direction des politiques de l’eau et Centre d’expertise en analyse environnementale du
Québec., http://www.mddep.gouv.qc.ca/pesticides/mais_soya/index.htm DACO: 8.6

Proposed Re-evaluation Decision – PRVD2015-01
Page 300

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1398453

1560632

1640595

Giroux, I. et al, 2006, Part 3: La présence de pesticides dans l’eau au Québec, Bilan
dans les cours d’eau de zones en culture de maïs et de soya en 2002, 2003 et 2004 et
dans les réseaux de distribution d’eau potable. Ministère du Développement durable,
de l’Environnement et des Parcs, Direction du suivi de l’état de l’environnement,
Direction des politiques de l’eau et Centre d’expertise en analyse environnementale du
Québec., http://www.mddep.gouv.qc.ca/pesticides/mais_soya/index.htm DACO: 8.6
2003 Pesticide Sampling Program for Selected Municipal Drinking Water Supplies in
New Brunswick.: Tables 4-6: Results by Municipality and QA/QC Samples. DACO:
8.6
Boldon, M., Harty, C., 2003 Pesticide Sampling Program for Selected Municipal
Drinking Water Supplies in New Brunswick, DACO: 8.6

1739313

John Struger, Dean Thompson, Bozena Staznik, Pamela Martin, Tana McDaniel, Chris
Marvin, 2007, Bulletin of Environmental Contamination and toxicology 80:378-384,
Occurrence of Glyphosate in Surface Waters of Southern Ontario - Glyphosate,
DACO: 8.6

2035772

2368762

Giroux, I. et al., 2010, Pesticides dans l’eau de surface d’une zone maraîchère
Ruisseau Gibeault-Delisle dans les « terres noires » du bassin versant de la rivière
Châteauguay de 2005 à 2007 Juin 2010, DACO: 8.6
Giroux, I. et al., 2010, Pesticides dans l’eau de surface d’une zone maraîchère
Ruisseau Gibeault-Delisle dans les « terres noires » du bassin versant de la rivière
Châteauguay de 2005 à 2007 Juin 2010, DACO: 8.6
Giroux, I., 2010, Présence de pesticides dans l’eau au Québec - Bilan dans quatre
cours d’eau de zones en culture de maïs et de soya en 2005, 2006 et 2007 et dans des
réseaux de distribution d’eau potable, DACO: 8.6
Elliott, J. et al., 2011, (2010). Groundwater vulnerability to pesticide contamination in
the Assiniboine Delta Aquifer. Environment Canada Pesticide Science Fund, DACO:
8.6
Giroux, I. and L. Pelletier, Présence de pesticides dans l’eau du Québec : bilan dans
quatre cours d’eau de zones en culture de maïs et de soya en 2008, 2009 et 2010,
DACO: 8.6
United States Geological Survey, 2013, Groundwater, DACO: 8.6

2417055

US EPA- STORET, STORET glyphosate data downloaded June 10, 2013, DACO: 8.6

2417068

USGS NAWQA, NAWQA glyphosate data downloaded June 10, 2013, DACO: 8.6

2417071

California Dept. of Pesticide Reg., CDPR glyphosate data downloaded June 10, 2013,
DACO: 8.6

2417074

US EPA- STORET, STORET AMPA data downloaded June 10, 2013, DACO: 8.6

2417075

USGS NAWQA, NAWQA AMPA data downloaded June 10, 2013, DACO: 8.6

2417077

California Dept. of Pesticide Reg., CDPR AMPA data downloaded June 10, 2013,
DACO: 8.6

2035772

2102602

2149078

2306368

Proposed Re-evaluation Decision – PRVD2015-01
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2423830

Messing, P.G., Farenhorst, A., Waite, D.T., McQueen, D.A.R., Sproull, J.F.,
Humpries, D.A. and L.L. Thompson, 2011, Predicting wetland contamination from
atmospheric deposition measurements of pesticides in the Canadian prairie pothole
region, DACO: 8.6

2423832

Battaglin, W.A., Kolpin, D.W., Scribner, E.A., Kuivila, K.M. and M.W. Sandstrom,
2005, Glyphosate, other herbicides, and transformation products in Midwestern
streams, 2002, DACO: 8.6
Edge, C.B., Thompson, D.G., Hao, C. and J.E. Houlahan, 2012, A silviculture
application of the glyphosate-based herbicide VisionMAX to wetlands has limited
direct effects on amphibian larvae, DACO: 8.6
Rueppel, M.L., Brightwell, B.B., Schaefer, J., Marvel J.T., 1977, Metabolism and
Degradation of Glyphosate in Soil and Water - Journal of Agricultural and Food
Chemistry, Volume 25, Number 3, Pages 517 to 528, DACO: 8.2.3.3.1

2423834

2459612

2459613

2459614

2459616

2459617

2459619

2459620

2459621

2459622

Barrett, K.A., McBride, M.B., 2005, Oxidative Degredation of Glyphosate and
Aminomethylphosphonate by Manganese Oxide - Environmental Science and
Technology Volume 39, Pages 9223 to 9228, DACO: 8.2.3.3.1
Lund-Hoie, K., Friestad, H.O., 1986, Photodegradation of the Herbicide Glyphosate in
Water - Bulletin of Environmental Contamination and toxicolog, Volume 36, Pages
723 to 729, DACO: 8.2.3.3.2
R. Atkinson, 1988, Estimation of gas-phase hydroxyl radical rate of constants for
organic chemicals - Environmental toxicology and Chemistry, Volume 7, Pages 435 to
442, DACO: 8.2.3.3.3
Jacob, G.S., Garbow, J.R., Hallas, L.E., Kimack, N.M., Kishore, G.M., 1988,
Metabolism of glyphosate in Pseudomonas sp. Strain L Br. - Applied and
Environmental Microbiology, Volume 54, Number 12, Pages 2953 to 2958, DACO:
8.2.3.4.2
Dick, R.E., Quinn, J.P., 1995, Glyphosate-degrading isolates from environmental
samples: occurrence and pathways of degredation - Applied Microbial Biotechnology,
Volume 43, Pages 545 to 550, DACO: 8.2.3.4.2
Kishore, G.M., Jacob, G.S., 1987, Degredation of Glyphosate by Pseudomonas sp.
PG2982 via a Sarcosine intermedate - Journal of Biological Chemistry, Volume 262,
Number 25, Pages 12164 to 12168, DACO: 8.2.3.4.2
Borggaard, O.K., Gimsing, A.L., 2008, Fate of glyphosate in soil and the possibility of
leaching to ground and surface waters: a review - Pest Management Science, Volume
64, Pages 441 to 456, DACO: 8.2.3.4.2,8.2.4
Grundmann, S. Dorfler, U., Ruth, B., Loos, C., Wagner, T., Karl, H., Munch, C.
Schroll, R., 2008, Mineralization and Transfer Process of 14C- labeled Pesticides in
Outdorr Lysimeters - Water Air Soil Pollution Focus Volume 8, Pages 177 to 185,
DACO: 8.2.3.4.2,8.2.4

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Accinelli, C., Koskinen, W.C., Seebinger, J.D., Vicari, A., Sadowsky, M.J., 2005,
Effects of incorporated Corn RESIDues on Glyphosate Mineralization and Sorption in
Soil - Journal of Agricultural and Food Chemistry, Volume 53, Pages 4110 to 4117,
DACO: 8.2.3.4.2

2459624

Laitinen, P, Siimes, K., Eronen, L., Samo, S., Welling, L., Oinonen, S., Mattsoff, L.,
Ruohonen-Lehto, M., 2006, Fate of the herbicides glyphosate, glufosinate-ammonium,
phenmedipham, ethofusmesate and metamitron in two Finnish arable soils - Pest
Management Science, Volume 62, Pages 473 to 491, DACO: 8.2.3.4.2
Al-Rajab, A.J., Schiavon, M., 2010, Degradation of 14C-glyphosate and
aminomethylphosphonic acid (AMPA) in three agricultural soils - Journal of
Environmental Science, Volume 22, Number 9, Pages 1374 to 1380, DACO: 8.2.3.4.2
Bergstrom, L., Borjesson, E. Stenstrom, J. , 2011, Laboratory and Lysimeter Studies
of Glyphoste and Aminomeethylphosphonic Acid in Sand and a Clay Soil - Journal of
Environmental Quality, Volume 40, Pages 98 to 108, DACO: 8.2.3.4.2,8.2.4
Landry, D., Dousset, S., Fournier, J-C., Andreux, G., 2005, Leaching of glyphosate
and AMPA under two soil management practices in Burgundy vineyards Environmental Pollution Volume 138, Pages 191 to 200, DACO: 8.2.4
Strange-Hansen, R., Holm, P.E., Jacobsen, O.S., Jacobsen, C.S., 2004, Sorption,
mineralization and mobility of N-(phosphonomehtyl)glycine (glyphosate) in five
different types of gravel - Pest Management Science Volume 60, Pages 570 to 578,
DACO: 8.2.3.3.1,8.2.4
Gimsing, A.L., Borggaard, O.K., Bang, M., 2004, influence of soil composition on
adsorption of glyphosate and phosphate by contrasting Danish surface soils - European
Journal of Soil Science, Volume 55, Pages 183 to 191, DACO: 8.2.4,8.2.4.2
California Department of Pesticide Regulation, 1998, Environmental Fate of
Glyphosate, DACO: 8.2.3.2

2459625

2459629

2459630

2459631

2459632

2459633
2459634

California Department of Pesticide Regulation, 1995, interim report of the pesticide
chemistry database - Appendix , DACO: 8.2.3.2

2459636

Tu, M., Hurd, C. Randall, J.M. and the Nature Conservancy, 2001, Weed Control
Methods Handbook: tools and Techniques for use in Natural Areas - All US
Government Documents (Utah Regional Depository) Paper 533, DACO: 8.2.3.3.2

2459639

Carlisle, S.M., Trevors, J.T., 1988, Glyphosate in the Environment - Review article Water, Air and Soil Pollution Volume 39, Pages 409 to 420, DACO: 8.2.3.3.2

2459642

Chang, F-C., Simcik, M.F., Capel, P.D., 2011, Occurrence and fate of the herbicide
glyphosate and its degradate aminomehtylphosphonic acid in the atmosphere Environmental toxicology and Chemistry, Volume 30, Number 3, Pages 548 to 555,
DACO: 8.2.3.3.3

2459645

Food and Agriculture Organization of the United Nations (FAO), 2001, FOA
specifications and evaluations for plant protection products: glyphosate, DACO:
8.2.3.2

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2459647

2459648

2459649

Moshier, L., Penner, D., 1978, Use of Glyphosate in Sod Seeding Alfalfa (Medicago
sativa) Establishment - Weed Science, Volume 26, Number 2, Pages 163 to 166,
DACO: 8.2.4
Mamy, L., Barriuso, E., Gabrielle, B., 2005, Environmental fate of herbicides
triflualin, metazachlor, metamitron and sulcotrione compared with that of glyphosate,
a substitute broad spectrum herbicide for different glyphosate-resistant crops - Pest
Management Science, Volume 61, Pages 905 to 916, DACO: 8.2.4
Sheals, J., Sjoberg, S., Persson, P., 2002, Adsorption of glyphosate on Geothite:
molecular characterization of surface complexes - Environmental Science and
Technology, Volume 36, Pages 3090 to 3095, DACO: 8.2.4
Hance, R.J., 1976, Adsorption of glyphosate by soils - Pesticide Science, Volume 7,
Pages 363 to 366, DACO: 8.2.4.2

2459650

Gimsing, A.L., Borggaard, O.K., Jacobsen, O.S., Aamand, J., Sorensen, J., 2004,
Chemical and microbiological soil characteristics controlling glyphosate
mineralisation in Danish surface soils - Applied Soil Ecology, Volume 27, Pages 233
to 242, DACO: 8.2.4.2

2459651

de Jonge, H., de Jonge, L.W., Jacobsen, O.H., Yamaguchi, T., Moldrup, P., 2001,
Glyphosate sorption in soils of different pH and phosphorus content - Soil Science
Volume 166, Number 4, Pages 230 to 238, DACO: 8.2.4.2
Laitinen, P., Ramo, S., Nikunen, U., Jauhiainen, L., Siimes, K., Turtola, E., 2009,
Glyphosate and phosphorus leaching and RESIDues in boreal sandy soil - Plant Soil,
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DACO: 9.9
Wang, N. et al., 2005, influence of Sediment on the Fate and toxicity of a
Polyethoxylated Tallowamine Surfactant System (MON 0818) in Aquatic
Microcosms, DACO: 9.9
Elliott, J.E. et al, 2011, Chapter 9 - Amphibians are Not Ready for Roundup - Wildlife
Ecotoxicology: Forensic Approaches, Emerging Topics in Ecotoxicology 3, DOI
10.1007/978-0-387-89432-4_9, DACO: 11.1,9.9

2160348

Solomon, Keith R., E.J.P. Marshall, and Gabriel Carrasquilla, 2009, Human Health
and Environmental Risk from the Use of Glyphosate Formulations to Control the
Production of Coca in Columbia: Overview and Conclusions - Journal of Toxicology
and Environmental Health, Part A, Volume 72, Pages 914 to 920, DACO: 11.1,9.9

2160350

M.H. Bernal, K.R. Solomon, and G. Carrasquilla, 2009, Toxicity of Formulated
Glyphosate (Glyphos) and Cosmo-Flux to Larval Columbian Frogs 1. Laboratory
Acute Toxicity - Journal of Toxicology and Environmental Health, Part A, Volume
72, Pages 961 to 965, DACO: 11.1,9.9

2160351

M.H. Bernal, K.R. Solomon, and G. Carrasquilla, 2009, toxicity of formulated
Glyphosate (Glyphos) and Cosmo-Flux to Larval and Juvenile Columbian Frogs 2.
Field and Laboratory Microcosm Acute toxicity - Journal of toxicology and
Environmental Health, Part A. Volume 72, Pages 966 to 973, DACO: 11.1,9.9

2160353

Gahl, Meagan K, Bruce D. Pauli, and Jeff E. Houlahan, 2011, Effects of Chytrid
Fungus and a Glyphosate-Based Herbicide on Survival and Growth of Wood Frogs
(Lithobates sylvaticus) - Ecological Applications, Volume 21, Number 7, Pages 2521
to 2529, DACO: 11.1,9.9
Mann, Reinier M., Ross V. Hyne, Catherine B. Choung, and Scott P. Wilson, 2009,
Amphibians and Agricultural Chemicals: Review of the Risk in a Complex
Environment - Environmental Pollution, Volume 157, Pages 2903 to 2927, DACO:
11.1,9.9

2160354

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Moore, Lindsay J., 2012, Relative toxicity of the Components of the Original
formulation of Roundup to Five North American Anurans - Ecotoxicology and
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Popescu, Viorel D. et al, 2012, The Role of Forest Harvesting and Subsequent
Vegetative Regrowth in Determining Patterns of Amphibian Habitat Use - Forest
Ecology and Management, Volume 270, Pages 163 to 174, DACO: 9.9
Thompson. 2012. Natural Resources Canada, 2012, Forest Herbicide Research
Bulletin 53, DACO: 9.9
Chen, Celia Y., Kevin M. Hathaway, and Carol L. Folt, 2004, Multiple Stress Effects
of Vision Herbicide, pH, and Food on Zooplankton and Larval Amphibian Species
from Forest Wetlands - Environmental Toxicology and Chemistry, Volume 23,
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Wang, Y-S., Yen, J-H., Hsieh, Y-N., Chen, Y-L., 1994, Dissipation of 2,4-D,
glyphosate and paraquat in river water - Water, Air and Soil Pollution Volume 72,
Pages 1 to 7, DACO: 9.4.8
Wang, Y-S., Jaw, C-G., Chen, Y-L., 1994, Accumulation of 2,4-D and glyphosate in
Fish and water Hyacinth - Water, Air and Soil Pollution, Volume 74, Pages 397 to
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Romero, D.M., de Molina. M.C.R., Juarez, A.B., 2011, Oxidative stress induced by a
commercial glyphosate formulation in a tolerant strain of Chlorella kessleri Ecotoxicology and Environmental Safety, Volume 74, Pages 741 to 747, DACO:
9.8.2,9.8.3

2462228

Lipok, J., Studnik, H., Gruyaert, S., 2010, The toxicity of Roundup 360 SL
formulation and its main constituents: Glyphosate and isopropylamine towards nontarget water photoautotrophs - Ecotoxicology and Environmental Safety, Volume 73,
Pages 1681 to 1688, DACO: 9.8.2,9.8.3

2462229

Shiogiri, N.S., Paulino, M.G., Carraschi, S.P., Baraldi, F.G., de Cruz, C., Fernandes,
M.N., 2012, Acute exposure of a glyphosate-based herbicide affects the gills and liver
of the Neotropical fish, Piaractus mesopotamicus - Environmental toxicology and
Pharmacology, Volume 34, Pages 288 to 296, DACO: 9.5.2.3

2462230

Filizadeh, Y. Rajabi Islami, H., 2011, toxicity determination of three sturgeon species
exposed to glyphosate - Iranian Journal of Fisheries Science, Volume 10, Number 3,
Pages 383 to 392, DACO: 9.5.2.3
Vera-Candioti, J., Soloneski, S., Larramendy, M.L., 2012, Evaluation of the genotoxic
and cytotoxic effects of glyphosate-based herbicides in the ten spotted live-bearer fish
Cnesterodon decemmaculatus (jenyns, 1842) - Ecotoxicology and Environmental
Safety, Volume 89, Pages 166 to 173, DACO: 9.5.2.3

2462231

2462232

Chandrasekera, W.U., Weeratunga, N.P., 2012, The lethal impacts of roundup
(glyphosate) ont eh fingerlings of guppy, Poecilia reticulata Peters, 1859 Aquatculture Asia, Volume XVII, Number 1, Pages 39, DACO: 9.5.2.3

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2462234

Hued, A.C., Oberhofer, S., Bistoni, M.A., 2012, Exposure to a commercial glyphosate
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2462235

Shiogiri, N.S., Carraschi, S.P., Cubo, P., Schiavetti, B.L., da Cruz, C., Pitelli, R.A.,
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DACO: 9.5.2.3

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2462243

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Uchida, M., Takumi, S., Tachikawa, K., Yamauchi, R., Goto, Y., Matsusaki, H.,
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Le, T-H., Lim, E-S., Lee, S.K., Choi, Y-W., Kim, Y-W., Min, J., 2010, Effects of
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Mottier, A., Kientz-Bouchart, V., Serpentinit, A., Lebel, J.M., Jha, A.N., Costil, K.,
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Osterberg, J.S., Darnell, K.M., Dlickley, T.M., Romano, J.A., Rottschof, D. , 2012,
Acute toxicity and sub-lethal effects of common pesticides in post-larval and juvenile
blue crabs, Callinectes sapidus - Journal of Experimental Marine Biology and
Ecotoxicology, Volumes 424 to 425, Pages 5 to 14, DACO: 9.4.2

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2462245

Bernard, M.B., Cole, P., Kobelt, A., Horne, P.A., Altmann, J., Wratten, S.D., Yen,
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2462247

Druart, C., Scheirfler, R., Millet, M. de Vaufleury, A., 2012, Land snail eggs
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Druart, C., Scheirfler, R., de Vaufleury, A., 2010, towards the development of an
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2469274

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2469295

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Wang, N, Besser, J.M. , Buckler, D.R., Honegger, J.L., Ingersolls, C.G., Johnson,
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2462217
2462218

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2469261

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