G LYPHOSATE RED September 1993

i 

### GLYPHOSATE REREGISTRATION ELIGIBILITY TEAM Office of Pesticide Programs: Special Review and Reregistration Division Eric Feris

.................................................. Reregistration Branch Health Effects Division Jane Smith

........................................ Chemical Coordination Branch Krystyna Locke

.............................................. Toxicology Branch I Jeff Evans

........................... Occupational and Residential Exposure Branch Randolph Perfetti

......................... Chemistry Branch - Reregistration Support Biological and Economic Analysis Division James G. Saulmon

..................................... Biological Analysis Branch Eric Maurer

........................................... Economic Analysis Branch Environmental Fate and Effects Division Candace Brassard

..................................... Ecological Effects Branch Kevin Poff

............................. Environmental Fate and Groundwater Branch Bernice Slutsky

............................ Science Analysis and Coordination Staff Registration Division Mark Perry

.......................................... Registration Support Branch Karen P. Hicks

....................................... Fungicide-Herbicide Branch Policy and Special Projects Staff Jean Frane

............................. Food Safety & Regulation Tracking Section

Office of General Counsel: Pesticides and Toxic Substances Division Debra Burton

................................................. Pesticides Branch
Office of Compliance Monitoring: Policy and Grants Division Beverly Updike

................................... FIFRA Policy & Analysis BranchG LYPHOSATE RED September 1993

ii 

### TABLE OF CONTENTS

GLOSSARY OF TERMS AND ABBREVIATIONS

.......................... vi 

### EXECUTIVE SUMMARY

.................................................. viii 

### I. INTRODUCTION

..................................................... 1 

### II. CASE OVERVIEW

................................................... 2
A. Chemical Overview

............................................... 2
B. Use Profile

....................................................... 2 C. Estimated Usage of Pesticide

..................................... 7
D. Data Requirements

............................................... 9
E. Regulatory History

............................................... 9 

### III. SCIENCE ASSESSMENT

........................................... 9
A. Product Chemistry

............................................... 9
B. Human Health Assessment

....................................... 10
1. Toxicology Assessment

....................................... 10

a. Acute Toxicity

......................................... 10 b. Subchronic Toxicity

.................................... 11

c. Chronic Toxicity

....................................... 12 d. Carcinogenicity

........................................ 13

e. Developmental Toxicity

................................. 15G LYPHOSATE RED September 1993

iii

f. Reproductive Toxicity

................................... 16
g. Mutagenicity

.......................................... 17
h. Metabolism

........................................... 17
i. Neurotoxicity

.......................................... 18 j. Other Toxicological Endpoints

........................... 19
k. Reference Dose

....................................... 19
2. Exposure Assessment

........................................ 20

a. Dietary Exposure

...................................... 20 b. Occupational and Residential

............................ 21
3. Risk Assessment

............................................ 23

a. Dietary

............................................... 23
b. Occupational and Residential

............................ 24

c. Dietary Exposure References

............................ 24 C. Environmental Assessment

....................................... 30
1. Environmental Fate

.......................................... 30

a. Environmental Fate and Transport

........................ 30 b. Environmental Fate and Groundwater Assessment

.......... 37
2. Ecological Effects

........................................... 37

a. Ecological Hazard

..................................... 37 b. Ecological Effects Risk Assessment

...................... 53 

### IV. RISK MANAGEMENT AND REREGISTRATION DECISION

........ 57G LYPHOSATE RED September 1993

iv A. Determination of Eligibility

........................................ 57
1. Eligibility Decision

........................................... 57
2. Eligible and Ineligible Uses

................................... 58
B. Regulatory Position

.............................................. 58
1. Tolerance Re-assessment

.................................... 58
2. Labeling Rationale

........................................... 70
3. Endangered Species Statement

............................... 70 

### V. ACTIONS REQUIRED BY REGISTRANTS

.......................... 70
A. Manufacturing-Use Products

...................................... 70
1. Additional Generic Data Requirements

.......................... 70
2. Labeling Requirements for Manufacturing-Use Products

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

................................................ 71
1. Additional Product-Specific Data Requirements

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

.................... 72

a. Nonaquatic

........................................... 72 b. Aquatic

.............................................. 72 C. Existing Stocks

.................................................. 74 

### VI. APPENDICES

........................................................ 74 Appendix A- Use Patterns Subject to Reregistration Appendix B - Table of the Generic Data Requirements and Studies Used to Make the

Reregistration DecisionG LYPHOSATE RED September 1993

v Appendix C - Citations Considered to be Part of the Data Base Supporting the

Reregistration of Glyphosate Appendix D - List of Available Related Documents Appendix E - Pesticide Reregistration Handbook Appendix F - Generic and Product-Specific Data Call-In
! Attachment 1 - Chemical Status Sheet ! Attachment 2 - Generic Data Call-In and Product Specific Data Call-In Response

Forms with Instructions ! Attachment 3 - Generic Data Call-In and Product Specific Data Call-In

Requirements Status and Registrants' Response Forms with Instructions ! Attachment 4 - EPA Grouping of End Use Products for Meeting Acute Toxicology

Data Requirements. ! Attachment 5 - EPA Acceptance Criteria ! Attachment 6 - List of all Registrant(s) sent this Data Call-In ! Attachment 7 - Cost Share/Data Compensation FormsG LYPHOSATE RED September 1993

vi



### GLOSSARY OF TERMS AND ABBREVIATIONS
a.i. Active Ingredient CAS Chemical Abstracts Service CFR Code of Federal Regulations CSF Confidential Statement of Formula EEC Estimated Environmental Concentration. The estimated pesticide concentration

in an environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FFDCA Federal Food, Drug, and Cosmetic Act
FR Federal Register
HDT Highest Dose Tested LC 50 Median Lethal Concentration. A statistically derived concentration of a

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

cause death in 50% of the test animals when administered by the route indicated (oral or dermal). It is expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
LD lo Lethal Dose-low. Lowest Dose at which lethality occurs
LEL Lowest Effect LevelG LYPHOSATE RED September 1993

vii MATC Maximum Allowable Toxicant Concentration: A range at which the pesticide

causes no effect (NOEL) and the lowest dose at which an effect was observed (LOEL).
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking

studies submitted. N/A Not Applicable NPDES National Pollutant Discharge Elimination System NOEL No Observed Effect Level OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
ppm Parts Per Million
REI Restricted Entry Interval RfD Reference Dose RS Registration Standard
TD Toxic Dose. The dose at which a substance produces a toxic effect. TC Toxic Concentration. The dose at which a substance produces a toxic effect. TMRC Theoretical Maximum Residue Contribution. WPS Worker Protection StandardG LYPHOSATE RED September 1993

viii 

### EXECUTIVE SUMMARY This document addresses the reregistration eligibility of the pesticide glyphosate. There are 63 glyphosate-containing products registered for use in the United States. The isopropylamine salt of glyphosate, the active ingredient in 53 of these registrations, is used as a herbicide to control a number of broadleaf weeds and grasses. The principal food use sites include corn, wheat, sorghum, citrus and stone fruits, potatoes and onions, asparagus, coffee, peanuts, and pineapples. There are also a number of non-food use sites including ornamental, turf, forestry, and industrial rights-of-way. Two registrations contain the sodium salt of glyphosate and are used in sugarcane fields. In addition there are seven herbicide/plant regulation products containing the monoammonium salt of glyphosate which were registered subsequent to the development of List A and are not a subject of this RED. Except where explicitly noted otherwise, the term "glyphosate," when used in this document, refers to either the technical acid or the isoproplyamine and sodium salts of glyphosate. However, the monoammonium salt is included in the tolerance expression. Available data have been sufficient to allow re-assessment of existing tolerances, which includes the monoammonium salt of glyphosate. In June 1986, the Agency issued the document "Registration Standard for Pesticide Products Containing Glyphosate as the Active Ingredient" (NTIS #PB87-103214). The Registration Standard required scientific studies in the areas of phytotoxicity, environmental fate, toxicology, product chemistry, and residue chemistry. With the exception of a few waived studies, all of the data required have been submitted. After completing its review for reregistration, the Agency now concludes that the data base on glyphosate is substantially complete. Based on the results of its reregistration review, EPA has concluded that all registered uses of glyphosate are eligible for reregistration. The Agency has classified glyphosate as a Group E carcinogen (signifies evidence of non-carcinogenicity in humans). A Reference Dose of 2 mg/kg/day has been recommended. This proposal is based on a maternal NOEL of 175 mg/kg/day from a rabbit developmental toxicity study and an uncertainty factor of 100. The dietary risk assessment is based on a worst-case scenario, assuming treatment of 100% of acreage and highest legal residue values which likely result in an overestimation of exposure and risk. Even with these values, however, dietary exposure is expected to be minimal. There are 85 tolerances established for various crops and crop groups as well as Federal Food, Drug, and Cosmetic Act §409 tolerances for processed food and animal feed and animal tolerances. A re-assessment of tolerances is included in this document and there are no major changes in the previously-established tolerances. Studies show that glyphosate is no more than slightly toxic to birds and is practically non-toxic to fish and honeybees. However, a toxic inert in glyphosate end use products necessitates the labelling of someG LYPHOSATE RED September 1993

ix products "toxic to fish" since some glyphosate products are applied directly to aquatic environments. The Agency does have concerns regarding the potential hazard to endangered plant species and the Houston toad. However, the Agency is not requiring any modification of use or label changes in this document. A Federal Register Notice on the Endangered Species Protection Plan and subsequent guidance to registrants will impose appropriate exposure mitigation measures for areas where endangered plant species and the Houston toad may be encountered. In addition, there have been a number of reported incidents of spray drift damage to non-target crops. Spray drift studies are required as is a Tier II Vegetative Vigor study. These studies are not part of the target data base for reregistration of glyphosate. Before reregistering each product, the Agency is requiring that product specific data in the areas of product chemistry and acute toxicology, revised Confidential Statements of Formula, and revised labeling be submitted within eight (8) months of the issuance of this document. In an effort to reduce the time, resources, and number of animals needed to fulfill the acute toxicology data requirements for glyphosate-containing end use products, the Agency has "batched" products considered to be similar with respect to acute toxicity testing requirements. After reviewing these data and the revised labels, the Agency will determine whether to re-register a product based on whether or not that product meets the requirements in Section 3(c)(5) of FIFRA. End use products containing glyphosate in combination with other active ingredients will not be re-registered until the Reregistration Eligibility Decisions for all active ingredients contained in that product are issued and all the active ingredients contained in the product are also eligible for reregistration. However, product specific data for these products are being called in at this time.G LYPHOSATE RED September 1993

1 EPA's reviews of data on the set of registered uses considered for EPA's analysis may be obtained from the OPP Public Docket, Field Operations Division (H7506C), Office of Pesticide Programs, EPA, Washington, DC 20460.

1 

### I. INTRODUCTION

In1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended to accelerate the reregistration of products with active ingredients registered prior to November 1, 1984. The amended Act provides a schedule for the reregistration process to be completed in nine years. There are five phases to the reregistration process. The first four phases of the process focus on identification of data requirements to support the reregistration of an active ingredient and the generation and submission of data to fulfill the requirements. The fifth phase is a review by the U.S. Environmental ProtectionAgency (referred to as "the Agency") of all data submitted to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine whether pesticides containing such active ingredient are eligible for registration" before calling in data on products and either re-registering products or taking "other appropriate regulatory action." Thus, reregistration involves a thorough review of the scientific data bas e underlying a pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards arising from the currently registered uses of the pesticide; to determine the need for additional data on health and environmental effects; and to determine whether the pesticide meets the "no unreasonable adverse effects" criterion of FIFRA.
Thisdocument presents the Agency's decision regarding the reregistration eligibility of the registered uses of the isopropylamine salt and the sodium salt formulations of glyphosate. Except where explicitly noted otherwise, the term "glyphosate," when used inthis document, refers to either the technical acid or the isoproplyamine and sodium salts of glyphosate but does not cover the monoammonium salt productssince the compound was not included in the Federal Register publication of List A. The document consists of six sections. Section I is the introduction. Section II describes glyphosate, its uses, data requirements and regulatory history. Section III discusses the human health and environmental assessment based on the data available to the Agency. Section IV presents the reregistration decision for glyphosate. Section V discusses the reregistration requirements for glyphosate. Finally, Section VI is the Appendices which support this Reregistration

Eligibility Document. Additional details concerning the Agency's review of applicable data are available on request. 1G LYPHOSATE RED September 1993

2 

### II. CASE OVERVIEW
A. Chemical Overview

The following active ingredient(s) are covered by this Reregistration Eligibility Document: Common Name: glyphosate Chemical Name: N-phosphonomethyl glycine CAS Registry Number: 38641-94-0 OPP Chemical Codes: 103601 (isopropylamine salt) 103603 (sodium salt) Empirical Formula: C 3 H 8 NO 5 P Trade Names: Roundup, Rodeo, Shackle Basic Manufacturer: Monsanto Company 800 N. Lindbergh Blvd. St. Louis, MO 63167
B. Use Profile

The following is information on the current registered uses with an overview of use sites and application methods. A detailed table of the uses of glyphosate is given in Appendix A. Chemical: glyphosate, isopropylamine salt (103601) Type of Chemical: herbicide Mechanism of Action: not known at this time, but it appears to inhibit the aromatic amino acid biosynthesis pathway and may inhibit or repress chlorismate mutase and/or prephenate hydratase.G LYPHOSATE RED September 1993

3

Use groups and sites: AQUATIC FOOD CROP: ag ricultural drainage systems, irrigation systems, lakes/ponds/reservoirs (with human or wildlife use), streams/rivers/channeled water. AQUATIC NON-FOOD INDUSTRIAL: aquatic areas/water, drainage systems, sewage systems. AQUATIC NON-FOOD OUTDOOR: aquatic areas/water FORESTRY: conifer release, forest plantings (reforestation programs), forest trees (all or unspecified). GREENHOUSE FOOD CROP: greenhouses-in use. INDOOR NON-FOOD: greenhouse-empty. OUTDOOR RESIDENTIAL: household/domestic dwellings outdoor premises. TERRESTIAL FEED CROP: alfalfa,barley, beans, buckwheat, corn, grass forage/fodder/hay, lentils, millet (proso), nongrass forage/fodder/straw/hay, oats, pastures, rye, sorghum, wheat. TERRESTRIAL FOOD CROP: acerola (West Indies Cherry), apricot, artichoke (Jerusalem), asparagus, atemoya, avocado, banana, beech nut, beets, blackberry, blueberry, boysenberry, brazil nut, breadfruit

(breadnut), broccoli, brussels sprouts, butternut, cabbage, cabbage (Chinese), carambola (jalea), carrot (including tops), cashew, cauliflower, celery, chard (swiss), cherimoya, cherry, chestnut, chicory, cocoa, coffee, collards, cranberry, cress (water), cucumber, currant, date, dewberry, eggfruit tree (canistel), eggplant, elderberry, endive (escarole), fig, filbert (hazelnut), garlic, gooseberry, gourds, groundcherry (strawberry tomato/tomatillo), guava, hickory nut, horseradish, huckleberry, jaboticaba, jackfruit, kale, kitembilla (ceylon gooseberry), kiwi fruit, kohlrab i, leek, lettuce, litchi nut, loganberry, longan, loquat, macadamia nutG LYPHOSATE RED September 1993

4

(bushnut), mamey (mammee apple), mango, marmaladebox (genipapo), mayhaw (hawthorn), melons, melons (cantaloupe), melons (honeydew), melons (mango), melons (musk), melons (water), melons winter (casaba/crensha w/honeydew/persian), mustard, nectarine, okra, olive, onion, papaya, parsley, passion fruit, peach, pear, pecan, pepper, persimmon, pistachio, plantain, plum, pomegranate, prune, pumpkin, quince, radish, raspberry (black, red), rhubarb, rutabaga, sapodilla, sapota (white), soursop, spinach, squash (summer), squash (winter), sugar apple (custard apple), sweet potato, tamarind, taro, tea, walnut (English/black), yam. TERRESTRIAL FOOD + FEED CROP: agricultural

fallow/idleland, almond, apple, barley, beans, beets (unspecified), buckwheat, calamondin, citron (citrus), citrus hybrids other than tangelo, corn (unspecified), corn (field), cotton (unspecified), grapefruit, grapes, kumquat, lemon, lentils, lime, millet proso (broomcorn), mustard, oats, orange, parsnip, peanuts (unspecified), peas (unspecified), pineapple, potato (white/irish), pummelo (s haddock), rape, rice, rice (wild), rye, sorghum, soybeans (unspecified), sugar beet, sugarcane, tangelo, tangerines, tomato, triticale, turnip, wheat. TERRESTRIAL + GREENHOUSE NON-FOOD CROP: ornamental and/or shade trees, ornamental woody shrubs and vines. TERRESTRIAL NON-FOOD CROP: agricultural

fallow/idleland, agricultural rights-of-way/fencerows/hedgerows, agricultural uncultivated areas, airports/landing fields, christmas tree plantations, golf course turf, industrial areas (outdoor), nonagricultural outdoor buildings/structures, nonagricultural rights-of-way/fencerows/hedgerows, nonagricultural

uncultivated areas/soils, ornamental and/or shade trees, ornamental lawns and turf, ornamental woody shubs and vines, paths/patios, paved areas (private roads/sidewalks), recreational areas, urban areas. TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL: ornamental and/or shade trees, ornamental herbaceous plants, ornamental lawns and turf, ornamental woody shubs and vines.G LYPHOSATE RED September 1993

5

Pests: many broadleaf and grass weeds Formulation types registered: SINGLE ACTIVE INGREDIENT: Form Not Identified/Liquid 53.50 % glyphosate, isopropylamine salt 41.00 % glyphosate, isopropylamine salt Form Not Identified/Solid 76.00 % glyphosate, isopropylamine salt Liquid-Ready to Use 19.70 % glyphosate, isopropylamine salt 18.30 % glyphosate, isopropylamine salt 15.80 % glyphosate, isopropylamine salt 1.00 % glyphosate, isopropylamine salt 0.96 % glyphosate, isopropylamine salt 0.50 % glyphosate, isopropylamine salt Manufacturing Use 94.00 % glyphosate, isopropylamine salt Pelleted/Tableted 83.50 % glyphosate, isopropylamine salt 60.00 % glyphosate, isopropylamine salt Pressurized Liquid 0.96 % glyphosate, isopropylamine salt 0.75 % glyphosate, isopropylamine salt Soluble Concentrate/Liquid 62.00 % glyphosate, isopropylamine salt 53.80 % glyphosate, isopropylamine salt 41.50 % glyphosate, isopropylamine salt 41.00 % glyphosate, isopropylamine salt 28.60 % glyphosate, isopropylamine salt 25.10 % glyphosate, isopropylamine salt 18.00 % glyphosate, isopropylamine salt 10.00 % glyphosate, isopropylamine salt 8.20 % glyphosate, isopropylamine salt 7.00 % glyphosate, isopropylamine salt 5.00 % glyphosate, isopropylamine salt Soluble Concentrate/Solid 93.96 % glyphosate, isopropylamine saltG LYPHOSATE RED September 1993

6

MULTIPLE ACTIVE INGREDIENT: Liquid-Ready to Use 12.40 % glyphosate, isopropylamine salt + 1 other A.I. 7.70 % glyphosate, isopropylamine salt + 1 other A.I. 0.50 % glyphosate, isopropylamine salt + 1 other A.I. 0.25 % glyphosate, isopropylamine salt + 1 other A.I. Soluble Concentrate/Liquid 16.50 % glyphosate, isopropylamine salt + 1 other A.I. 14.80 % glyphosate, isopropylamine salt + 1 other A.I. 13.30 % glyphosate, isopropylamine salt + 1 other A.I. 12.90 % glyphosate, isopropylamine salt + 1 other A.I. Methods and rates of application (Given in maximum active (acid equivalent (ae)) rates, except as otherwise noted): Broadcast or spray; for example as needed: Form Not Identified/Liquid - rates were not specified in Appendix A dated 8/12/93; Form Not Identified/Solid - rates were not specified in Appendix A dated 8/12/93; Liquid-Ready to Use - applied at rate of 3.08 lb ae/A; Pelleted/Tableted - applied as a spot treatment, for example from a hand held sprayer; Pressurized Liquid - applied as a spot treatment, for example from an aerosol can; Soluble Concentrate/Liquid - applied at rate of 7.5 lb ae/A; Soluble Concentrate/Solid - applied at rates of 0.09 gal ae/A;

Chemical: glyphosate, sodium salt (103603) Type of Chemical: plant regulator Mechanism of Action: modifies plant growth; hastens fruit ripeningG LYPHOSATE RED September 1993

7

Use Groups and Sites: TERRESTRIAL FOOD + FEED CROP: peanuts (unspecified); sugarcane Formulation Types Registered: SINGLE ACTIVE INGREDIENT: soluble concentrate/solid 75.0% glyphosate, sodium salt Methods and Rates of Application: soluble concentrate/solid - applied as ground spray at peanut bloom stage at 0.0375 lb a.i./A in 10 gal water;
soluble concentrate/solid - applied as aerial spray at sugarcane ratoon stage at 0.525 lb a.i./A in 5 gal water. Use Limitations: sugarcane - 21 days preharvest interval; peanuts - 84 days preharvest interval. Do not apply this product through any type of irrigation system. C. Estimated Usage of Pesticide

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

**Glyphosate Usage**
**Site Multiple Acres** 

**Treated (x1000) Pounds AI** 

**(x1000)**
non-ag areas unknown 3000-7000 almonds 350-390 500-550G LYPHOSATE RED September 1993

8 apples 75-275 65-200 barley 550-600 275-325 cherries 15-95 20-125 corn, field 1,300-1,700 1,100-1,200
cotton 300-1,000 225-375 hay/pasture 3,000-3,500 1,500-1,700 dry edible beans/peas 50 20 grapefruit 70-140 183-375
grapes 45-550 25-265 lemons 5-75 10-70 other ag sites 3,000-3,500 1,000-1,500
oranges 300-600 650-1,300 peaches 10-150 10-110 peanuts 10-30 5-10
pears 15-50 15-65
pecans 5-300 5-150 plums/prunes 5-80 5-40 rice 30-55 25-30 sorghum 450-550 100-150 soybeans 2,600-4,800 2,200-2,400 spring wheat 200-225 50-60
sugarcane 10-70 5-35 potatoes 20-40 25-30 sunflowers 60-70 25-40
sweet corn 10-30 5-15
tomatoes 30-40 15-30 green beans/peas 20-40 5-20 walnuts 150-175 100-125 winter wheat 350-1,150 250-450G LYPHOSATE RED September 1993

9 **TOTAL 12,985-20,280**  **11,398-18,745**

Ina typical year between 1989 and 1991, approximately 13-20 million acre treatmentswere made with 18.7 million pounds active ingredient. Hay/pasture (20%) , soybeans (20%), field corn (9%), and other agricultural areas (20%) comprise 71% of the total acreage treated with glyphosate. Non-agricultural areas (33%), soybeans (15%), hay/pasture (11%), and corn (8%) comprise 67% of the total pounds of active ingredient applied.
D. Data Requirements

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

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

assessment of all data which were submitted in response to the Registration Standard. 

### III. SCIENCE ASSESSMENT
A. Product ChemistryG LYPHOSATE RED September 1993

10 Empirical Formula: C 3 H 8 NO 5 P Molecular Weight: 169.07 CAS Registry No.: 38641-94-0 Shaughnessy No.: 103601 (isopropylamine salt, IPA)

103603 (sodium salt) The glyphosate (N-phosphonomethyl glycine) salts are nonselective herbicides and plant growth regulators. The technical isopropylamine salt (IPA) is a white crystalline solid with a melting point of 200 E C and a bulk density of 1.74 lb/ft 3

. It is 1% soluble in water at 25 E C and insoluble in ethanol, acetone, or benzene.The technical sodium salt is a white crystalline solid which decomposes at 140 E C with a bulk density of 30 lb/ft 3

. B. Human Health Assessment
1. Toxicology Assessment

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

a. Acute Toxicity

The table below summarizes the toxicity results and categories for technical grade glyphosate. The acute inhalation study was waived by the Agency since glyphosate technical is a nonvolatile solid and adequate inhalation studies were conducted on the end-use product formulations.

**Acute Toxicity**
**Test Result**  **Category** Acute Oral (rat) ( 1 ) > 4320 mg/kg III Acute Dermal (rabbit)( 1 ) > 2 g/kg III Acute Inhalation ( 1 ) Not Required N/A 1 - MRID 00067039
The following table is derived from MPs considered

toxicologically similar to glyphosate technical.G LYPHOSATE RED September 1993

11 **Acute Toxicity**
**Test Result**  **Category** Eye Irritation ( 1 ) mild irritation, clears in 7 days III
Dermal Irritation ( 2 ) slight irritation IV Skin Sensitization ( 3 ) negative N/A 1 - MRID 41400603 2 - MRID 41400604 3 - MRIDs 00137137, 00137138, 00137139, 00137140 Other studies submitted to the Agency give similar results. They are acceptable for reregistration (MRIDs 41400601, and 41400602) b. Subchronic Toxicity

Ina 90-day feeding study Sprague-Dawley rats were fed diets containing 0, 1000, 5000 or 20000 ppm of glyphosate for three months. These doses were equivalent to 0, 63, 317 and 1267 mg/kg/day, respectively (males) and 0, 84, 404 and 1623 mg/kg/day, respectively

(females). The following findings were regarded as possiblytreatment-related: (1) increased serum phosphorus and potassium in all treated groups, males and females; (2) increased serum glucose in the mid-dose and high-dose males; (3) increased blood urea nitrogen

(BUN) and serum alkaline phosphatase in the high-dose males; and (4) occurrence of pancreatic lesions in the high-dose males (pancreas was not examined in the low-dose and mid-dose groups). Based on these findings, the systemic NOEL is < 1000 ppm (not determined definitively) for both sexes. (MRIDs 40559401, and 00093879) In a second 90-day feeding study CD-1 mice were fed diets containing 0, 250, 500 or 2500 mg/kg/day of glyphosate for three months. Body weight gains of the high-dose males and females were about 24% and 18% lower, respectively, than those of the controls. Body weight gains of the low-dose and mid-dose groups were comparable to those of the controls. Based on the reducedG LYPHOSATE RED September 1993

12 body weight gains in both sexes, the NOEL for systemic toxicity is 500 mg/kg and the LOEL is 2500 mg/kg. (MRID 00036803) In a 21-day dermal study glyphosate was applied to the skin of New Zealand white rabbits using 10 rabbits/sex/dose (5 with intact and 5 with abraded skin). The levels of glyphosate tested were 10, 1000 or 5000 mg/kg/day. The rabbits were exposed for three consecutive weeks, 6 hours/day, 5 days/week. Treatment-related e ffects observed only in the high dose groups included: (1) very sl ight erythema and edema in intact and abraded skin of both sexes; (2) decreased food consumption in males; and (3) decreased serum lactic dehydrogenase in both sexes. Based on these effects, the NOEL for

males and females is 1000 mg/kg/day and the LOEL is 5000 mg/kg/day. (MRID 00098460)
The required 90-day feeding study in dogs is satisfied by the one-year dog feeding study. (MRID 00153374)

c. Chronic Toxicity

A chronic feeding/carcinogenicity study was conducted using male and female Sprague-Dawley rats which were fed diets containing 0, 30, 100 or 300 ppm of glyphosate for 26 months. Theselevels were equivalent to 0, 3, 10 and 31 mg of glyphosate/kg/day, respectively, for the males and 0, 3, 11 and 34 mg of glyphosate/kg/day, respectively, for the females. There were no effects based on any of the parameters examined (toxic signs, mortality, body weights, food consumption, hematology, clinical chemistry, urinalysis, organ weights and organ/tissue pathology). Therefore,the NOEL for systemic toxicity is $300 ppm (HDT; males: 31 mg/kg/day and females: 34 mg/kg/day). (MRID 00093879)
A second chronic feeding/carcinogenicity study was conducted using male and female Sprague-Dawley rats which were fed diets containing 0, 2000, 8000 or 20000 ppm of glyphosate for 2 years. These levels were equivalent to 0, 89, 362 or 940 mg/ kg/day, respectively, for the males and 0, 113, 457 or 1183 mg/kg/day, respectively, for the females. Treatment-related effects observed only in the high-dose group included: (1) In the females: decreased body weight gains; and (2) In the males: increased incidence of cataracts and lens abnormalities, decreased urinaryG LYPHOSATE RED September 1993

13 pH, increased absolute liver weight and increased liver weight/brain weightratio (relative liver weight). No significant systemic effects were observed in the low-dose and mid-dose male and female groups. Therefore, the NOEL for systemic toxicity is 8000 ppm (males: 362 mg/kg/day and females: 457 mg/kg/day) and the LOEL is 20000 ppm (HDT; males: 940 mg/kg/day and females: 1183 mg/kg/day). (MRID 41643801)
A chronic study was conducted using male and female beagle dogs which were given glyphosate in gelatin capsules containing 0, 20, 100 or 500 mg/kg/day for one year. There were no effects based on all parameters examined, in all groups. Therefore, the NOEL for

systemic toxicity is $500 mg/kg/day, for both sexes. (MRID 00153374) d. Carcinogenicity

A chronic feeding/carcinogenicity study was conducted using Sprague-Dawley

rats which were fed diets containing glyphosate (males: 0, 3, 10 or 31 mg/kg/day and females: 0, 3, 11 or 34 mg/kg/day) for 26 months. The following findings were observed in the high-dose groups when compared with the concurrent controls: (1) increased incidence of thyroid C-cell carcinomas in females; and (2) increased incidence of interstitial cell (Leydig cell) testicular tumors. However, the Agency concluded that these neoplasms were not treatment- related and glyphosate was not considered to be carcinogenicin this study because the incidence of thyroid carcinomas was not statistically significant and the incidence of testicular tumors was within the historical incidence. The Agency also concluded that this study was not conducted at high enough dose levels for an adequate negative carcinogenicity. (MRID 00093879)
A chronic feeding/carcinogenicity study was conducted using Sprague-Dawley rats fed diets containing glyphosate (males: 0, 89, 362 or 940 mg/kg/day and females: 0, 113, 457 or 1183 mg/kg/day) for 2 years. The study showed a slightly increased incidence of (1) pancreaticislet cells adenomas in the low-dose and high-dose males; (2) hepatocellular (liver) adenomas in the low-dose and highdose males; and (3) thyroid C-cells adenomas in the mid-dose and high-dose males and females. The Agency concluded that theseG LYPHOSATE RED September 1993

14 adenomas were not treatment-related and glyphosate was not considered to be carcinogenic in this study. With respect to pancreaticislet cells adenomas, there was no statistically significant pos itive dose-related trend in their occurrence; there was no progressionto carcinomas; and the incidence of pancreatic hyperplasia(non-neoplastic lesion) was not dose-related. With respectto hepatocellular adenomas, the increased incidence of these neoplasms was not statistically significant in comparison with the controls; the incidence was within the historical control range; therewas no progression to carcinomas; and the incidence of hyperplasia was not compound-related.With respect to thyroid Ccell adenomas, there was no statistically significant dose-related trend in their occurrence; the increased incidence was not statistically

significant; there was no progression to carcinomas; and therewas no significant dose-related increase in severity or incidence of hyperplasia in either sex. (MRID 41643801)
A carcinogenicity study in mice was conducted with CD-1 mice fed diets containing 0, 150, 750 or 4500 mg/kg/day of glyphosate for 18 months. No effects were observed in the low-dose and mid-dose groups. The following findings were observed in the high-dose group: (1) decreased body weight gain in males and females; (2) increased incidence of hepatocellular hypertrophy, hepatocellular

necrosis and interstitial nephritis in males; (3) increased incidence of proximal tubule epithelial basophilia and hypertrophy in

females; and (4) slightly increased incidence of renal tubular adenomas, a rare tumor, in males. Based on these effects, the systemic NOEL and LOEL were 750 mg/kg/day and 4500 mg/kg/day, respectively. The Agency concluded that the occurrence of these adenomas was spontaneous rather than compound-induced because the incidence of renal tubular adenomas in males was not statistically significant when compared with the concurrent controls. Anindependent group of pathologists and biometricians also conducted extensive evaluations of these adenomas and reached the same conclusion. Therefore, glyphosate was not considered to be carcinogenic in this study. (MRIDs 00130406, and 00150564) OnJune 26, 1991, the Agency classified glyphosate in Group E (evidence of non-carcinogenicity for humans), based on a lack of convincing evidence of carcinogenicity in adequate studies with two animal species, rat and mouse.G LYPHOSATE RED September 1993

15

e. Developmental Toxicity

A developmental toxicity study was conducted with pregnant Charles River COBS CD rats which were administered 0, 300, 1000 or 3500 mg/kg/day of glyphosate by gavage during gestation days 6 through 19. Treatment-related effects observed only in the highdose dams included: (1) diarrhea; (2) decreased mean body weight gain; (3) breathing rattles; (4) inactivity; (5) red matter around the nose and mouth, and on forelimbs and dorsal head; (6) decreases intotal implantations/dam and inviable fetuses/dam; and (7) deaths (6/25 or 24% of the group). Treatment-related developmental effects observed only in the high-dose group included: (1) increased number of litters and fetuses with unossified sternebrae; and (2) decreased mean fetal body weights. Therefore, the NOEL and LOELfor maternal toxicity are 1000 mg/kg/day and 3500 mg/kg/day, respectively. The NOEL and LOEL for developmental toxicity are 1000 mg/kg/day and 3500 mg/kg/day, respectively. (MRID 00046362)
Ina second study, pregnant Dutch Belted rabbits were administered 0, 75, 175 or 350 mg/kg/day of glyphosate by gavage during gestation days 6 through 27. Treatment-related findings were observed only in the high-dose group and included: (1) diarrhea; (2) nasa l discharge; and (3) death (10/16 or 62.5% of does died by gestation day

21). Developmental toxicity was not observed at any dose tested. Therefore, the NOEL and LOEL for maternal toxicity are 175 mg/kg/day and 350 mg/kg/day, respectively. The NOEL for developmental

toxicity is $175 mg/kg/day. Due to high maternal mortality at the 350 mg/kg/day dose level, too few litters (only 6) were available to assess adequately developmental toxicity at that level. (MRID 00046363)
f. Reproductive Toxicity

A reproduction study was conducted with male and female Sprague-Dawley rats which were administered 0, 3, 10 or 30 mg/kg/day

of glyphosate continuously in the diet for three successive generations. The only effectobserved was an increased incidence of focal tubular dilation of the kidney (both unilateral and bilateral combined) in the high-dose male F 3b pups. Therefore, the NOEL for systemicand reproductive toxicity is $30 mg/kg/day (HDT). TheG LYPHOSATE RED September 1993

16 NOEL and LOELfor developmental toxicity are 10 mg/kg/day and 30 mg/kg/day, respectively. (MRID 00105995)
Anotherreproduction study was conducted with SpragueDawley rats which were administered 0, 100, 500 or 1500 mg/kg/day of glyphosate continuously in the diet for two successive generations. Treatment-related effects observed only in the highdose group included: (1) soft stools, very frequent, in the F o and F 1 males and females; (2) decreased food consumption and body weightgain of the F o and F 1 males and females during the growth (premating) period; and (3) decreased body weight gain of the F 1a , F 2a and F

2b male and female pups during the second and third weeks of lactation. Focal tubular dilation of the kidneys, observed in the previous study (00105995), was not observed at any dose level in this study. Based on the above findings, the systemic NOEL and LOEL are 10000 ppm (500 mg/kg/day) and 30000 ppm (1500 mg/kg/ day), respectively. The reproductive NOEL is 30000 ppm (1500 mg/kg/day; HDT); and the developmental NOEL and LOEL are 10000 ppm (500 mg/kg/day) and 30000 ppm (1500 mg/kg/day), respectively. (MRID 41621501) Since the focal tubular dilation of the kidneys was not observed at the 1500 mg/kg/day level (HDT) in the 2-generation rat reproduction

study but was observed at the 30 mg/kg/day level (HDT) in the 3-generation rat reproduction study (00105995), the Agency concluded that the latter was a spurious rather than glyphosate-related effect.G LYPHOSATE RED September 1993

17

g. Mutagenicity

A Gene mutation assay in an Ames Test was conducted using glyphosate, both with and without metabolic activation. The strains of Salmonellatyphimurium used were TA98, TA100, TA1535 and TA1537. No increases in reverse mutations were observed at any concentration. (MRID 00078620)
A gene mutation assay in mammalian cells was conducted using glyphosate in the Chinese hamster ovary (CHO) cells/hypoxanthine - guanine -phosphoribosyl transferase (HGPRT) assay, with and without metabolic activation. No mutagenic response was observed either with or without metabolic activation up to the limit of cytotoxicity (10 mg/Ml). (MRID 00132681)
A Structural Chromosomal Aberration Assay was conducted using a single dose of glyphosate administered intraperitoneally (i.p.) to male and female Sprague-Dawley rats. The dose used was 1 g/kg of body weight and the bone marrow cells were examined for clastogenic (chromosome-damaging) effect. No significant clastogenic effects were observed. (MRID 00132683)
Ina fourth study, glyphosate was tested in two assays: the rec-as say using B. subtilis H17 (rec + ) and M45 (rec - ); and the reverse mutation assays using E. coli WP2 hcr and Salmonella typhimurium strains TA98, TA100, TA1535,TA1537 and TA1538, with and without metabolic activation. No increases in mutations were observed in either study. (MRID 00078619)
h. Metabolism

Two metabolism studies with rats are available. In the first study, single or repeated doses of radiolabeled 14 C-glyphosate were administered orally to male and female Sprague-Dawley rats. Following a single oral dose of 14 C-glyphosate,30 to 36% of the dose was absorbed and less than 0.27% of the dose was eliminated as CO2 . Ninety-seven

point five percent of the administered dose was excreted in the urine and feces as the parent compound, gl yphosate. Amino methyl phosphonic acid (AMPA) was the only metabolite found in urine (0.2-0.3% of the administered dose) and feces (0.2-0.4% of the administered dose). Less than 1.0% of theG LYPHOSATE RED September 1993

18 absorbed dose remained in tissues and organs, primarily in bone tissue. Repeated dosing at 10 mg/kg did not significantly change the metabolism, distribution or excretion of glyphosate. (MRIDs 40767101, and 40767102)
Ina second study, male and female Sprague-Dawley rats received single intraperitoneal injections of radiolabeled 14 Cglyphosate.The dose level of glyphosate used for male and female rats was 1150 mg/kg.Blood samples were collected 0.25, 0.50, 1, 2, 4, 6 and 10 hoursafter injection. Femoral bone marrow samples were collected from one third of the male and female rats sacrificed at 0.5, 4, or 10 hours after injection. Thirty minutes after injection of glyphosate, the concentration of radioactivity in the bone marrow of male and female rats was equivalent to 0.0044% and 0.0072%, respectively, of the administered dose. Assuming first order kinetics, the decrease in radioactivity in bone marrow occurred with a half-life of 7.6 and 4.2 hours for males and females, respectively. Similarly, the half-lives of the radioactivity in plasma were approximately

1 hour for both sexes. These findings indicate that very little glyphosate reaches bone marrow, that it is rapidly eliminated from bone marrow and that it is even more rapidly eliminated from plasma. (MRID 00132685)
i. Neurotoxicity

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

19

j. Other Toxicological Endpoints

A dermal penetration study (guideline 85-2) with technical grade glyphosate is not being required because there are no toxicological endpoints to indicate this study is necessary. DomesticAnimal Safety Studies (86-1) are not being required for the use patterns of glyphosate (a plant growth regulator and herbicide). Technical

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

k. Reference Dose

OnAugust 27, 1992, the Agency's Office of Pesticide Programs Reference Dose (RfD) Peer Review Committee recomm ended that the RfD for glyphosate be established at 2 mg/kg/day. This value was based on the maternal NOEL of 175 mg/kg/day from the rabbit developmental toxicity study (00046363) and an uncertainty factor (UF) of 100. This RfD has not yet been confirmed by the Agency RfD Work Group.
InSeptember of 1986, the Joint Food and Agricultural Organization

of the United Nations (FAO)/World Health Organization (WHO) on Pesticides Residues [JMPR] proposed an Allowable DailyIntake (ADI) of 0.3 mg/kg body weight for glyphosate per se

. The ADI wasbased on a 26-month feeding study in the rat yielding a NOEL of > 31 mg/kg body weight per day and and uncertainty factor of 100. The Agency places more importance on the developmental

rabbit study since no effect was observed in the 26- month study whereas maternal mortality was observed in the d evelopmental rabbit study in the high dose group. JMPRG LYPHOSATE RED September 1993

20 acknowledged that there is no effect at the highest dose tested in the 26-month rat study.
2. Exposure Assessment

a. Dietary Exposure

The qualitative nature of the residue in plants is adequately understood.Studies with a variety of plants including corn, cotton, soybeans, and wheat indicate that the uptake of glyphosate or its metabolite, aminomethyl phosphonic acid (AMPA), from soil is lim ited. The material which is taken up is readily translocated. Foliarly applied glyphosate is readily absorbed and translocated throughout

the trees or vines to the fruit of apples, coffee, dwarf citrus (calamondin), pears and grapes. Metabolism via N-methylation yields N-methylated glycines and phosphonic acids. For the most part, the ratio of

glyphosate to AMPA is 9 to 1 but can approach 1 to 1 in a few cases (e.g., soybeans and carrots). Much of the residue data for crops reflects a detectable residue of parent (0.05 - 0.15 ppm) along with residues below the level of detection (<0.05 ppm) of AMPA. The terminal residue to be regulated in plants is glyphosate per se

. The qualitative nature of the residue in animals is adequately understood . Studies with lactating goats and laying hens fed a mixture of

glyphosate and AMPA indicate that the primary route of elimin ation was by excretion (urine and feces). These results are consistentwith metabolism studies in rats, rabbits, and cows. The terminal residues in eggs, milk, and animal tissues are glyphosate a nd its metabolite AMPA; there was no evidence of further metabolism. The terminal residue to be regulated in livestock is glyphosate per se

. Anadequate enforcement method is available for analysis of residues of glyphosate and its metabolite AMPA in or on plant commodities and inwater. This method utilizes GLC (Method I of PAM Vol. II; limit of detection is 0.05 ppm). For enforcement of tolerances in animal commodities, an HPLC method with fluorescence detection is available; the reported limits of detection are 0.01 ppm for glyphosate and 0.012 ppm for AMPA.G LYPHOSATE RED September 1993

21 The available storage stability data indicate that residues of glyphosate and its metabolite AMPA are stable under frozen storage conditions (-20 E C ): in or on plant commodities for a period of 1 year, in animal commodities for 2 years, and in water for 1 year. No additional storage stability data are needed. All data requirements for magnitude of the residue in plants have been evaluated and deemed adequate. Additional potato processing data are being generated. All data requirements for magnitude of the residue in plants as a result of irrigation with glyphosate-treated water have also been submitted and are adequate to support registered use and applicable tolerances. No additionaldata are required for magnitude of the residue in animals, potable water, and fish. A list of residue chemistry study references is provided on page 24.

b. Occupational and Residential

Occupational

and residential exposure can be expected based on the currently registered uses of products containing glyphosate.However, due to the low toxicity (acute category III) of glyphosate and the lack of other toxicological concerns (i.e carcinogenicity) occupational and residential exposure data are not required. Glyphosate is a non-selective herbicide applied to terrestrialfood and non-food crops, turf, greenhouse crops, and noncrop areas where total vegetation control is desired. Glyphosate, when applied at lower rates, is also a plant growth regulator. Although glyphosate meets the Agency's exposure criteria for post-application/reentry and/or mixer/loader/applicator exposure monitoring data, glyphosate does not meet the Agency's toxicity criteria for these data requirements. Acute oral and dermal toxicity data for the technical material are in Toxicity Category III and IV. In a ddition, glyphosate is poorly absorbed dermally. The acute inhalation

toxicity study for the technical material was waived because glyphosate is non-volatile and because there were adequate inhalation studies with end-use products showing low toxicity. Therefore, occupational and residential exposure data are not required to support the reregistration of glyphosate. (For theseG LYPHOSATE RED September 1993

22 sa me reasons, these data were not required in the 1986 Registration Standard.)
The following information is product-specific related, but is presented here for informational purposes. Some glyphosate enduse products are in Toxicity Category I and II based on primary eye irritation or dermal irritation. In California, where physicians are required to report pesticide poisonings, glyphosate was ranked third out of the 25 leading causes of illnesses or injury due to pesticides used between 1980 and 1984. These mixer/loader/applicator reported incidents consisted of eye and skin irritation. In reports issued by California since then (1987 and 1988), glyphosate continued to be a leading cause of illnesses or injuries (primarily eye and skinirritation). In the 1986 Registration Standard, the Agency recommended personal protective equipment, including protective eyewear for mixer/loader/applicators using end-use products that could cause eye or skin irritation. At that time, it was determined that mixer/loaders were at risk of eye or skin injury from splashes during mixing and loading. The Agency did not require personal protective equipmentfor users of "homeowner" products (containing up to 10% glyphosa te) because of the low concentration of glyphosate and because the products are "ready-to-use", requiring no mixing; therefore, the potential for eye or dermal exposure is minimized. The Agency, at this time, is not adding any additional personalprotective equipment requirements to the labels of end-use products; however, any existing personal protective equipment on those labels must be retained. The Worker Protection Standard (WPS) for Agricultural Pesticides -- 40 CFR Parts 156 and 170 -- established an interim restricted entry interval (REI) of 12 hours for glyphosate because the acute toxicity categories of glyphosate for acute dermal toxicity, skin irritation potential, and eye irritation potential are Toxicity Category III or IV. The Agency has determined that the 12-hour REI for all WPS sites should be retained as a prudent measure to mitigate risk to workers entering treated areas after application. Furthermore, give n the known irritation-effects concerns for glyphosate, the Agency considers the additional protections offered by the requirements in the WPS essential to its decision that a 12-hour REI for this chemical will offer sufficient risk mitigation to workers.G LYPHOSATE RED September 1993

23 Therefore,during the REI the Agency will allow workers to enter areas treated with glyphosate during the REI only in the few narrow exceptions allowed in the WPS.
The Agency has determined that, at this time, the entry restrictions discussed in this section need not apply to uses of glyphosate ouside the scope of the Worker Protection Standard for Agricultural

Chemicals, including out-of-scope commercial uses and h omeowner uses. The predicted frequency, duration, and degree of exposure due to post-application as the result of such uses should not warrant the risk

mitigation measures being required for persons engaged in the production of agricultural plants for commercial or research purposes.
3. Risk Assessment

a. Dietary

The chronic dietary risk analysis used tolerance level residues and assumed all acreage, of the crops considered, was treated with glyphosate to estimate the Theoretical Maximum Residue Contribution (TMRC) for the overall U.S. population and 22 population

subgroups. These exposures (TMRCs) were then compared to the RfD for glyphosate to estimate chronic dietary risk. The calculated TMRC for the overall U.S. population from food uses of

glyphosate is 0.025 mg/kg bwt/day, which represents 1.2% of the RfD. The subgroup most highly exposed, non-nursing infantsless than one year old, has a TMRC of 0.058 mg/kg bwt/day, or 2.9% of the RfD. Over one third of the dietary exposure and risk from glyphosate is due to the proposed tolerances on wheat. Thisanalysis was meant to be a "worst case" scenario of risk. The inclusion of recommended tolerances for reregistration as well as tolerances recommended for revocation; the use of the highest existing, pending, or recommended residue value for each com modity; and the assumptions of tolerance level residues and treatment of 100 percent of the crops for every commodity considered result in an overestimation of exposure and risk values for glyphosate (though there is some underestimation due to the lack of consumption information for some of the commodities to whichG LYPHOSATE RED September 1993

24 glyphosate is expected to be applied). Nonetheless, given the risk valuesarrived at by this analysis, EPA concludes that the chronic dietary risk posed by this pesticide on these food uses is minimal. b. Occupational and Residential

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

c. Dietary Exposure References

Thistable references the residue data used to support the reregistrationof glyphosate and includes the commodities eligible for reregistration.

Guideline/Commodity References 1
§171-4 (a): Plant Metabolism 00038771, 00039141, 00051983, 00065753, 00108097, 00108129, 00108133, 00108140, 00108151, 00111945
§171-4 (b): Animal Metabolism 00094971, 00108098, 00108099, 00108100, 00108101, 00108116, 00108099, 00108200, 40541301-40541304 §171-4 (c) and (d): Residue Analytical Methods 00028853, 00036222, 00036223, 00036231, 00037688, 00038770, 00038979, 00044423, 00051982, 00053002, 00053005, 00060108, 00061559, 00063714, 00065751, 00065752, 00067425, 00076805, 00078823, 00078824, 00108133, 00108144, 00108149, 00108151, 00108175, 00108176, 00108186, 00108231, 00111945, 00111949, 00122715, 00159419, 00164729, 40502601, 40541304 §171-4 (e): Storage Stability 00039142, 00040083, 00051980, 00053002, 00061553, 00061555, 00108129, 00108132, 40502605, 40532004, 41940701G LYPHOSATE RED September 1993

Guideline/Commodity References 1

25 §171-4 (k) (l): Magnitude of the Residue in Plants Root and Tuber Vegetables Group - Artichokes, Jerusalem N/A - Beets, garden 00108159 - Carrots 00108159 - Chicory N/A - Horseradish N/A - Parsnips N/A - Potatoes 00108151, 41947001

- Radish 00108159 - Rutabagas N/A - Salsify N/A - Sugar beets 00039381, 00108151
- Sweet potato 00108151 - Turnips 40835201

Leaves of Root and Tuber Vegetables Group - Beets, greens N/A - Chicory leaves N/A - Sugar beet tops 00039381, 00108151 - Turnip tops 40835201 Bulb Vegetables Group - Garlic N/A - Onions (green and dry bulb) 40783101 Leafy Vegetables (except Brassica) Group - Celery N/A - Lettuce (head and leaf) 00108159 - Spinach N/AG LYPHOSATE RED September 1993

Guideline/Commodity References 1

26 Brassica Leafy Vegetables Group - Broccoli 40802801, 40802801 - Cabbage 00108159 - Cauliflower N/A - Kale N/A - Mustard greens 40802801, 40802801 Legume Vegetables (Succulent/Dried) Group - Beans (succulent and dried) 00108159 - Lentils 00108159 - Peas (succulent and dried) 00108159 - Soybeans 00015759, 00015760, 00015761, 00015762, 00015763, 00015764, 00015765, 00015766, 00015767, 00024503, 00033954, 00038908, 00040084, 00061555, 00108153, 00108203 (processed commodities) 00061555, 00108153, 00156793 Foliage of Legume Vegetables (Succulent/Dried) Group - Bean vines and hay 00108159 - Lentil forage and hay 00108159 - Pea vines and straw - Soybean forage and hay 00015759, 00015760, 00015761, 00015762, 00015763, 00015764, 00015765, 00015766, 00015767, 00033954, 00038908, 00040084, 00061555, 00108153, 00108203 Fruiting Vegetables Group Cucurbit Vegetables Group Citrus Fruits Group 00039142 (processed commodities) 40159401 Pome Fruits Group 00108129 Stone Fruits Group 00111949G LYPHOSATE RED September 1993

Guideline/Commodity References 1

27 - Plums (fresh prunes) 00111949

Small Fruits and Berries Group - Blackberries - Blueberries - Cranberries 00053002 - Grapes 00038770, 00108132 (processed commodities) 40785303 - Raspberries
Tree Nuts Group 00111945 - Almond hulls 00111945 Cereal Grains Group - Barley 00038908, 00040087, 00044422, 00108203 (processed commodities) N/A - Corn (field and fresh) 00023336, 00023512, 00037687, 00038908, 00040085, 00048284, 00108203, 40502602 (processed commodities) 40502604, 41478101 - Oats 00038908, 00040087, 00044422, 00108203 (processed commodities) N/A - Rice 00038908, 00040087, 00044422 (processed commodities) N/A - Rye N/A (processed commodities) N/A - Sorghum 00038908, 00040087, 00044422, 00108203, 00109271, 40502601 (processed commodities) 40502603 - Wheat 00038908, 00040086, 00044426, 00108203, 00122715, 41484301 (processed commodities) 00150835 Forage, Fodder, and Straw of Cereal Grains Group - Barley forage, hay, and straw 00038908, 00040087, 00044422, 00108203G LYPHOSATE RED September 1993

Guideline/Commodity References 1

28 - Corn forage and fodder 00023336, 00023512, 00037687, 00038908, 00040085, 00048284, 00108203, 40502602 - Oat forage, hay, and straw 00038908, 00040087, 00044422, 00108203 - Rice straw 00038908, 00040087, 00044422 - Rye forage and straw N/A - Sorghum forage and fodder 00038908, 00040087, 00044422, 00108203, 00109271, 40502601 - Wheat forage and straw 00038908, 00040086, 00044426, 00108203, 00122715 Grass Forage, Fodder, and Hay Group 00076805, 00108147 Non-grass Animal Feeds (forage, fodder, straw, and hay) Group 00076805, 00108147

- Alfalfa seed 40541304

Miscellaneous Commodities - Acerola - Atemoya - Asparagus 00108144, 40642401 - Avocados 00108149 - Bananas 00108175 - Breadfruit 40149401 - Canistel 40149401 - Carambola - Cherimoya - Cocoa beans - Coconut - Coffee beans 00051980, 00051981 - Cotton 00060103, 00061553, 00108176, 00108153, 00108203 (processed commodities) 00061553, 00108176, 00108153 - Dates 40149401 - Figs - Genip - Guavas 00059050 - Jaboticaba 40149401 - Jackfruit 40149401G LYPHOSATE RED September 1993

Guideline/Commodity References 1

29 - Kiwi fruit - Litchi Nut (Lychee) - Longan - Mamey Sapote (Mammee Apple) - Mangoes 40580401 - Okra N/A - Olives 00108175, 42398401 (processed commodities) 00108175, 42398401 - Palm oil - Papayas 00063713 - Passion Fruit - Peanuts 00144341, 00028852 (processed commodities) 00144341, 00028852 - Persimmons 40149401 - Pineapple N/A - Pistachio 00111945 - Sapodilla - Sapote (black and white) 40149401 - Soursop 40149401 - Sugar apple - Sugarcane 00108140 (processed commodities) 00108168 - Tamarind 40149401 - Tea 00078823, 00078824 - Watercress N/A §171-4 (h): Magnitude of the Residue in Plants Resulting from the Use of Irrigation Water 00039381, 40541305

§171-4 (j): Magnitude of the Residue in Meat, Milk, Poultry, and Eggs 00108115, 40532001-03

§171-4 (g): Magnitude of the Residue in Fish 00036229, 00076491, 00154311, 00155120G LYPHOSATE RED September 1993

Guideline/Commodity References 1

30 §171-4 (f): Nature and Magnitude the Residue in Drinking and Irrigation Water 00039377, 00039381, 00077227, 00077228, 00077229, 00077230, 00077231, 00077232, 00077233, 00077234, 00077235, 00077236, 00077237, 00077238, 00077301, 00108173, §171-4 (i): Magnitude of the Residue in Food Handling Establishment
§171-5: Reduction of Residues
1 N/A means not available by MRID number. Those guidelines/commodities which do not list a MRID reference number, additional reference information can be provided from Table A in the Product and Residue Chemistry Chapters by R.B. Perfetti, Chemistry Branch Reregistration Support (CBRS# 10665) in the Health Effects Division dated 10/27/92 through FOI.
C. Environmental Assessment
1. Environmental Fate

a. Environmental Fate and Transport (1) Hydrolysis

Glyphosate is stable at pH 3, 6, 9 at 5 and 35 E C. (Accession 00108192) (2) Photodegradation in Water

Glyphosate isstable to photodegradation in pH 5, 7, and 9 buffered solutions under natural sunlight. (MRID 41689101) (3) Photodegradation on Soil

Glyphosate is stable to photodegradation on soil. (MRID 41335101) (4) Aerobic Soil MetabolismG LYPHOSATE RED September 1993

31 Data indicate half-life values of 1.85 and 2.06 days in Kickapoo sandy loam and Dupo silt loam respectively. Aminomethyl phosphonic acid (AMPA) was the major degradate. (MRID 42372501) (5) Anaerobic Aquatic Metabolism

Glyphosate has a half-life of 8.1 days in anaerobic (flooded plus nitrogen atmosphere) silty clay loam sediment. AMPA was the major degradate. (MRID 42372502) (6) Aerobic Aquatic Metabolism

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

K d values of 62, 90, 70, 22, and 175 were reported for Drummer silty clay loam, Ray silt, Spinks sandy loam, Lintoniasandy loam, and Cattail Swamp sediment respectively. After (aged) leaching 7 soils with 20" of water, the recovered radioactivity in the soils was 93-100% of the applied material. (Accessions 00108192, 00076493, 00108140) (8) Terrestrial Field Dissipation

The Agency has received an interim report on a terrestria l field dissipation study in progress by Monsanto Company. (MRID 42607501)
Thisreport contains data from eight different field sites. Some of the data from the individual field sites are deficient; however, the Agency may use the data from the eightfield sites together to satisfy the terrestrial field dissipation 164-1 data requirement.G LYPHOSATE RED September 1993

32 The interim report results from the first 12 months of bareground field dissipation trials from eightsites show that the median half-life (DT 50 ) for glyphosate applied at maximum annual use rates (7.95 lb a.e./acre, 10.7 lb a.i./acre) was 13.9 days with a range of 2.6 (Texas) to 140.6 (Iowa) days. Acceptable aerobic soil, aerobic aquatic and anaerobic aquaticmetabolism studies demonstrate that under those conditions at 25 E C in the laboratory glyphosate degrades rapidlywith half-lives of approximately 2, 7 and 8 days respectively. The reported half-lives (DT 50 ) from the field s tudies conducted in the coldest climates, ie. Minnesota, New York and Iowa, were the longest at 28.7, 127.8, and 140.6 days respectively indicating that glyphosate residues in the f ield are somewhat more persistent in cooler climates as opposed to milder ones (Georgia, California, Arizona, Ohio, and Texas). Glyphosate (as well as AMPA) was shown to remain predominantly in the 0-6 inch soil layer throughout the duration of the study

at all field sites. Iowa was the individual testsite to have average glyphosate residues, at all sampling times, greater than

0.01 ppm in the 6-12 inch depth. There were a number of detections from 0.01 to 0.09 ppm in the 6- 12 inch layer in Minnesota, New York and Texas, and glyphosate was detected at generally <0.05 ppm at the other 5 field sites (6-12 inch depth). Glyphosate was detected at three different sites below 12 inches. In California, at 0 DAT, average glyphosate residues were 0.21 ppm and 0.10 ppm in the 12-18 and 18- 24 inch soil horizons respectively. Soil core contamination was attributed to these detections since movement of residues to this depth on the first day of sampling is unlikely. In Arizona at 21 DAT the average glyphosate residues were 0.06, in the 18-24 inch soil layer. There were no glyphosate residues in the 6-12 or 12-18 inch soil layer in Arizona on 21 DAT and in subsequent samples below 12 inches which may indicate a problem with sampling technique. In Iowa at 190 DAT the average glyphosate residues were 0.05 ppm in the 12-18 inch soil layer. Since there were no glyphosate residues detected in the 6-12 inch soil layer at 190 DAT, andG LYPHOSATE RED September 1993

33 the lack of a significant amount of rainfall between sampling intervals in combination with the amount of time between sampling intervals and the high adsorptive characteristics of glyphosate give an indication that there may have been a problem with sampling technique.
AMPAwas also shown to remain predominantly in the 0-6 inch soil layer. AMPA was found at every test site on Day 0 samples indicating the rapid degradation of parent glyphosate.The AMPA levels generally reached a maximum between day

14 and day 30. Where the field half-lives were longer (Iowa, Minnesota, New York), the maximum average AMPAlevels occurred between 62 and 95 DAT. The maximum average AMPA levels found in the 0-6 inch soil layer were 0.6 ppm and occurred in Ohio and Georgia at 21 DAT and 61 DAT respectively. The AMPA levels at those sites had decreased to 0.12 and 0.44 ppm at 12 months after treatment. Inall samples but three, AMPA residue levels were <0.05 ppm in the 6-12 inch soil layer. In New York at 14 and 30 DAT average residues were detected at 0.06 ppm. In Iowa at the 92 DAT sample average AMPA residues were 0.08 ppm. Iowa and New York also exhibited 50% dissipation times of 140.6 and 127.8 days respectively.
AMPAlevels were detected at 0.06 ppm in the 18-24 inch soil layer on 21 DAT in Arizona and 0.04 and 0.03 ppm inthe 12-18 inch soil layer at 90 and 180 DAT respectively in New York.
A final report on the terrestrial field dissipation study showed the median

half-life (DT

50 ) (of eight sites) of AMPA was 240 days with a range of 119 (Ohio) to 958 (California) days. The half-lives for the dissipation of AMPA for seven of the eight test sites were:
! Arizona 142 days ! California 958 days ! Georgia 896 days ! Minnesota 302 daysG LYPHOSATE RED September 1993

34 ! New York 240 days ! Ohio 119 days ! Texas 131 days Iowa was not calculated because recharging of AMPA residues was greater than degradation. AMPA was shown to remain predominantly in the 0-6 inch soil layer throughout the duration of the study at all eight field sites. AMPA was detected three times (at a concentration greater than 0.05 ppm) at depths greater

than 12 inches. The three detections were attributed to contamination during sampling rather than vertical mobility. (9) Aquatic Field Dissipation

Glyphosate dissipated from water (irrigation source) with a calculated half-life of 7.5 days and 120 days from the sediment of the farm pond in Missouri. (MRID 40881601)
InMichigan, Georgia and Oregon pond and stream water, the maximum glyphosate concentrations were measured immediately posttreatment and dissipated rapidly. Glyphosate accumulated in the pond sediment, and to a lesser extent in the stream sediments; glyphosate was presentin pond sediment at $ 1 ppm in Michigan and Oregon at approximately 1 year posttreatment. (MRID 41552801) (10) Forestry Dissipation

When aerially applied at 3.75 lb/A to forested sites in Michigan, Oregon, and Georgia,glyphosate averaged 652- 1273 ppm in tree foliage immediately posttreatment. It then declined rapidlywith half-lives of <1 day at the Michigan and Georgia sites and <14 days at the Oregon site.
The forestry dissipation study results demonstrate that when used under normal silviculture practices according to labeldirections, the maximum combined glyphosate and AMPAresidue level in soil is less than 5 ppm. Glyphosate and AMPA residues in soil dissipate with time. The average half-life for

the dissipation of glyphosate was 100 days, andG LYPHOSATE RED September 1993

35 ranged from 35 to 158 days. The average half-life for the dissipationof AMPA was 118 days, and ranged from 71 days to 165 days. (MRID 41552801) (11) Accumulation in Confined Rotational Crops

Glyphosate residues (expressed as fresh weight) accumulated in lettuce, carrots, and barley planted 30, 119, and 364 days after sandy loam soil was treated with glyphosate at 3.71 lb ai/A. Accumulation decreased as the length of the rotation increased. In crops planted at 30 days, posttre atment, [ 14 C]residues at harvest were 0.097 ppm in lettuce,0.051 and 0.037 ppm in carrot tops and roots, respectively, and 0.188 and 0.175 ppm in barley grain and straw, respectively. In immature lettuce harvested at 40 and 60 days postplanting, [ 14 C]residues were 0.108 and 0.048 ppm, respectively. In crops planted at 119 days posttre atment, [ 14 C]residues at harvest were 0.037 ppm in lettuce,0.028 and 0.017 ppm in carrot tops and roots, respectively, and 0.078 and 0.056 ppm in barley grain and straw, respectively. In immature lettuce harvested at 28 and 48 days postplanting, [ 14 C]residues were 0.059 and 0.055 ppm, respectively. In crops planted at 364 days posttrea tment, [ 14 C]residues at harvest were 0.028 ppm in lett uce, 0.018 and 0.0096 ppm in carrot tops and roots, respectively, and 0.047 and 0.061 ppm in barley grain and straw, respectively. In immature lettuceharvested at 35 and 61 days postplanting, [ 14 C]residues were 0.057 and 0.043 ppm, respectively; in barley forage harvested at 48 days postplanting,[ 14 C]residues were 0.056 ppm. (MRID 41543201 and 41543202) (12) Accumulation in Irrigated Crops

Alfalfa,corn (grain and forage), grass (fescue or sudan) and lettuce were irrigated five to eight times during the 1987 growing season with glyphosate treated water containing a maximum of 21.3 ppm (on treatment day then fell to 0.46 ppm by 1 day after treatment) of glyphosate. Residues in the sediment beneath the treated water reached a maximum of 3.5 ppm at 14 days after treatment. ResiduesG LYPHOSATE RED September 1993

36 of glyphosate in the sprinkler water at the pond site were the highest 7 days after treatment at 0.12 ppm. One lettuce sample from the Missouri location (the pond site) at 29 days after treatment (of water source) and 5 irrigation events was found to contain 0.06 ppm glyphosate. (MRID 40541305) (13) Bioaccumulation in Fish

Maximum bioconcentration factors were 0.38X for edible tissues, 0.63X for nonedible tissues, and 0.52X for whole fish. (MRID 41228301)G LYPHOSATE RED September 1993

37 (14) Laboratory and Field Volatility

The requirement of these studies waswaived based on the low vapor pressure of glyphosate. b. Environmental Fate and Groundwater Assessment

Ingeneral, the available field and laboratory data indicate glyphosate adsorbs strongly to soil and would not be expected to move vertically below the 6 inch soil layer. Based on unaged batch equil ibrium studies glyphosate and glyphosate residues are expected to be immobile with Kd (ads) values ranging from 62 to 175. The mechanism of adsorption is unclear; however, it is speculated that it may be associated with vacant phosphate sorption sites or high levels of metallic soil cations. The data indicate that chemical and photochemical decomposition is not a significant pathway of degradation of

glyphosate in soil and water. However, glyphosate is readily degraded by soil microbes to aminomethyl phosphonic acid (AMPA), which is degraded to CO 2 , although at a slower rate than parent glyphosate. Even though glyphosate is highly water soluble it appears that parent glyphosate and AMPA have a low potentialto move to ground-water due to their strong adsorptive characteristics demonstrated in the laboratory and field studies. However, glyphosate does have the potential to contaminate surface waters due to its aquatic use patterns and erosion via transport of residues adsorbed to soil particles suspended in runoff water. If gly phosate were to reach surface water it would be resistant to hydrolysis and aqueous photolysis. Based on the low vapor pressure of glyphosate, volatilization from soils will not be an important dissipation mechanism. The low octanol/water

coefficient suggests that glyphosate will have a low tendency to accumulate in fish.
2. Ecological Effects

a. Ecological HazardG LYPHOSATE RED September 1993

38 (1) Effects to Nontarget Birds

To establish the toxicity of glyphosate to birds, tests were required using the technical grade material. (a) Avian Single-Dose Oral LD 50 - Technical

**Acute Oral Toxicity Findings Species**  **% AI LD** **50 (95% CL)**  **Conclusions**
Bobwhite quail 83% > 2000 mg/kg practically non-toxic to upland game birds

**One avian single-dose oral study on either a waterfowl species (preferably mallard duck) or an upland**  **species (preferably bobwhite quail) was required. These data indicate that technical glyphosate is**  **practically**

**non-toxic to an upland bird species on an acute oral basis. The guideline requirement for an avian acute oral study is fulfilled. (Study ID 234395)** 
(b) Avian Dietary - Technical
**Avian Subacute Dietary Toxicity Findings Species**  **% AI Reproductive**  **Impairment Conclusions** 

Mallard duck 98.5%

Tech > 4640 ppm no more than slightly toxic to upland game birds and waterfowl Bobwhite quail 98.% Tech > 4640 ppm

**Two subacute dietary studies, one study on a species of waterfowl (preferably mallard duck) and one on**  **an upland game bird species (preferably a bobwhite quail), were required. These data indicate that the**  **technical glyphosate is no more than slightly toxic to birds on a dietary basis. The guideline requirement**  **is fulfilled for both studies. (Study IDs 94171 and 00086492)**G LYPHOSATE RED September 1993

39 (c) Avian Reproduction
**Avian Reproduction Findings Species**  **% AI Reproductive**  **Impairment Conclusions** 

Mallard duck 83%

Tech No effects up to 1000

ppm not expected to cause reproductive impairment

Mallard duck 90.4%

Tech No effects up to 30

ppm Bobwhite quail 83%

Tech No effects up to 1000

ppm
**An avian reproduction test was required to support registration of the end-use products of glyphosate**  **since the following guideline criteria have been exceeded. The labeling for several use patterns contains**  **directions for use under which birds may be subject to repeated exposure to glyphosate. The labeling**  **allows repeat application for certain uses, such as alfalfa, barley, oats, apples, cherries, and oranges.**  **These data indicate that technical glyphosate is not expected to cause reproductive impairment. The**  **guideline requirements for an avian reproduction study on both upland game bird and waterfowl are**  **fulfilled. (Study IDs 235924, 00036328, and 235924)** (d) Summary of Findings

Glyphosate is practically non-toxic to bobwhite quailon the basis of acute oral toxicity. An LD 50 greater than 2000 mg/kg was determined for bobwhite quail given a single oral dose of technical glyphosate.Studies indicate that the 8-day dietary LC 50 of the chemical is greater than 4000 ppm for both mallard ducks and bobwhite quail. These data indicate that the chemical is slightly toxic to birds. Avianreproduction studies indicate reproductive impairmentwould not be expected at a dietary level of up to 1000 ppm. The available acute toxicity data do not indicate a requirement of precautionary labeling for birds on products containing glyphosate.G LYPHOSATE RED September 1993

40 (2) Effects on Non-Target Fish (a) Acute Toxicity to Freshwater Fish
**Acute Toxicity to Freshwater Fish Findings Species**  **% AI 48-hr LC**  **50 (95%CL)**  **Conclusions**

Bluegill sunfish 96.5% > 24 mg/l ranges in toxicity from slightly non-toxic to practically non-toxic to both cold water and warm water fish Fathead Minnow 87.3% 84.9 mg/l (72.9-99.3) Bluegill sunfish 83% 120 mg/l (111- 130) Rainbow Trout 83% 86 mg/l (70- 106) Rainbow Trout 96.7% 140 mg/l (120- 170) Fathead minnow 96.7% 97 mg/l (79- 120) Channel catfish 96.7% 130 mg/l (110- 160) Bluegill sunfish 96.7% 140 mg/l (110- 160) **The minimum data required for establishing the acute toxicity of glyphosate to freshwater fish are the**  **results of two 96-hour studies with the technical grade product. One study was to be performed on a cold**  **water fish species (preferably rainbow trout)**  **and one study was to be performed using a warm water**  **species (preferably bluegill sunfish). The results of these eight studies indicate that technical glyphosate**  **is slightly to practically**

**nontoxic to both cold water and warm water fish. The guidelines requirement for**  **acute toxicity testing of the technical on freshwater fish is fulfilled. (Study IDs 00108112, 00108171, 234395, 097661, and 249160)** G LYPHOSATE RED September 1993

41 (b) Chronic Toxicity to Freshwater Fish
**Chronic Toxicity to Freshwater Fish Findings Species**  **% AI Results**  **Conclusions**
Fathead Minnow 87.3%

tech MATC > 25.7 mg/l no effects at or below this level

**Due to the aquatic use of the chemical, its presence in water is likely to be continuous or recurrent**  **regardless of toxicity; therefore, chronic testing was required. This fish full life cycle study satisfies**  **the generic guideline requirement for chronic freshwater fish testing. (Study ID 00108171)**

**Acute Toxicity to Freshwater Fish Findings from Studies using Formulated Products**  **Species % AI** 

**(IPA salt) 96-hr LC**  **50**

**(95% CL) Conclusions** 

Bluegill sunfish 41.8% 5.8 mg/l (4.4-8.3) ranges in toxicity from moderately toxic to practically nontoxic to both warmwater and coldwater fish Rainbow Trout 41.8% 8.2 mg/l (6.4-9.0)

Channel catfish 41.36% 16 mg/l (9.4-26)

Rainbow Trout 41.36 11 mg/l (8.7-14)
Bluegill sunfish 41.36% 14 mg/l (8.7-24)

Fathead Minnow 41.36% 9.4 mg/l (5.6-16)

Rainbow Trout 62.4% >1000 mg/l
Bluegill sunfish 62.4% >1000 mg/l

Rainbow Trout *41.2% +

15.3 "AA" surfactant 120 mg/l (56-180)G LYPHOSATE RED September 1993

**Acute Toxicity to Freshwater Fish Findings from Studies using Formulated Products** 

42 Rainbow Trout *40.7% +

15% "W" surfactant 150 mg/l (100-

320)
Bluegill sunfish *40.7% +

15% "W" surfactant >100 mg/l

Bluegill sunfish *41.2% +

15.3% "AA" surfactant >180 mg/l

Rainbow Trout 7.03% +

0.5% "X77" 240 mg/l (180-320

mg/l)
Bluegill sunfish 7.03%+

0.5% "X77" 830 mg/l (620-

1600)

Rainbow Trout 51% 8.3 mg/l (7.0-9.9)

Fathead minnows 41% 2.3 mg/l (1.9-2.8)

Rainbow Trout 41% 9.0 mg/l (7.5-11)
Bluegill sunfish 41% 4.3 mg/l (3.4-5.5)

Channel catfish 41% 13 mg/l (11-16)
Bluegill sunfish 41% 5 mg/l (3.8-6.6)

Rainbow Trout 41% 1.3 mg/l (1.1-16)

**Testing of an end-use product is required if the pesticide will be introduced directly into an aquatic**  **environment**

**when used as directed by the label. Drainage systems would be included in such a category. Therefore,** **formulated product testing was required. According to the surfactant selected, the formulated product**  **toxicity ranges from moderately toxic to practically non-toxic. (Study ID 249159, 00070894,**G LYPHOSATE RED September 1993

43 **00070895,**

**00070897, 00070896, 00078661, 00078662, 00078658, 00078655, 00078656, 00078659, 00078664, 00078665, 249160)**  **Surfactant Test Findings Species**  **% AI 96-hour LC**  **50 (95% CL)**  **Conclusions**

Fathead minnow MONO818

Tech 100% 1.0 mg/l (1.2-

1.7) ranges in toxicity from highly toxic to slightly toxic to warmwater

and coldwater fish Rainbow trout MONO818

Tech 100% 2.0 mg/l (1.5-

2.7) Rainbow Trout MONO818 0.65 mg/l (.54- .78) Channel Catfish MONO8l8

Tech 100% 13 mg/l (10-17)
Bluegill sunfish MONO8l8

Tech 100% 3.0 (2.5-3.7)
Bluegill sunfish MONO818

Tech 100% 1 mg/l (.72-1.4)

**Testing of the surfactant may be required under unusual circumstances. When inerts are likely to be**  **toxic, testing can be required. These data indicate that MONO818 ranges from moderately toxic to very**  **highly toxic to both cold and warm water fish after 96 hour exposure. (Study ID 249160)** (c) Summary of Findings

Threetests on warm water species, one bluegill and two with fathead minnow, produced the 96-h our LC 50 s of 120 ppm, 84.9 ppm, and 97 ppm, respectively

(McAllister and Forbis 1978, ID #234395; EG & G Bionomics 1975, ID #00108171 and Folmar, Sanders, and Julin 1979, ID #249160). Two rainbow trout 96-hour LC 50 s provided values of 86 ppm and 140 ppm. Based on these tests, technical glyphosate ranges from slightly to practically non-toxic to freshwater fish species. Sur factant testing was performed with both cold water and warm water fish. In this case, the initial formulation

demonstrated an application rate muchG LYPHOSATE RED September 1993

44 lower than technical glyphosate. The LC 50 for rainbow trout was 1.3 mg/l or moderately toxic. The surfactant (MON0818) when tested alone produced an LC 5 0 value of 0.65 mg/l for rainbow trout indicating a highly toxiccategory (Folmar et al. 1979, ID #249160). In contrast, the formulation of 41.2 percent isopropylamine salt and 15.3 percent "AA" surfactant provided a rainbow trout LC 50 of 120 mg/l, indicating a practically non-toxic compound (Thompson and Griffen 1980, ID #00078658). Bluegill are in the same category of toxicity with an even higher LC 50 of greater than 180 mg/l (Thompson and Griffen 1980, ID #00078659). The bluegill and rainbow trout were similar in sensitivity to the formulation containing the "W" surfactant with LC 50 values of 150 and >100 mg/l, respectively. Also, neither rainbow trout (LC 50 240 mg/l) nor bluegill (LC 50 830 mg/l) were very sensitive to the x-77(.5) surfactant and glyphosate(7.03%). The surfactant MON0818 has been tested separately, producing an LC 50 of 13 mg/l on Chironomous

indicating it is a slightly toxic material. Forfish, the catfish appears to be the most tolerant with an LC 50 value of 13 mg/l, and rainbow trout the mostsensitive with an LC 50 value of 0.65 mg/l. Based upon available data products containing MONO8l8 must include the statement, "This pesticide is toxic to fish."G LYPHOSATE RED September 1993

45 (3) Effects on Aquatic Invertebrates (a) Acute Toxicity to Freshwater Invertebrates
**Acute Toxicity to Freshwater Invertebrates Findings Species**  **% AI 48-hr LC**  **50 (ppm)**  **Conclusions** Daphnia magna 83% tech 780 ranges in toxicity from slightly toxic to practically non-toxic to freshwater invertebrates Chironomus plumosus 96.7%

tech 55 (31-97)

**The minimum data requirement to establish the acute toxicity of glyphosate to freshwater invertebrates**  **is a 48-hour acute study using the technical material. Test organisms should be first instar**  Daphnia magna **or early instar amphipods, stone flies or mayflies. The results of these studies indicate that technical glyphosate is slightly toxic** **to** Chironomus plumosus **and is practically non toxic to** Daphnia magna **. The guideline requirement for acute testing on a freshwater invertebrate has been fulfilled.**  **(Study ID 00108172, and 249160)** (b) Chronic Toxicity to Freshwater Invertebrates

**Chronic Toxicity to Freshwater Invertebrates Findings Species**  **% AI Results**  **Conclusions** Daphnia magna 99.7%

tech MATC > 50 -<

96 mg/L caused reduced reproductive capacity

**Due to the aquatic use of the chemical its presence in water is likely to be continuous or recurrent**  **regardless of toxicity; therefore, chronic testing was required. This study satisfies the guideline**  **requirement for chronic freshwater invertebrate testing. (Study ID 249160)**

**Acute Toxicity to Freshwater Invertebrates Findings from Studies using Formulated Products**  **Species % AI** 

**(IPA salt) 48-hr LC**  **50**

**(ppm) Conclusions** 

Daphnia magna 62.4% 869 (703- 1019) ranges in toxicity from moderately toxic to practically non-toxic

to freshwater invertebratesG LYPHOSATE RED September 1993

**Acute Toxicity to Freshwater Invertebrates Findings from Studies using Formulated Products** 

46 Daphnia magna 7.03% +

X-77 surfactant @0.5% >1000

Daphnia magna 41.2% +

"AA" surfactant @ 15.3% 310 (250-

400)

Daphnia magna 40.7%

MON2139 + 15% "W" surfactant 72 (62-83)

Daphnia magna 41% 3 (2.6-3.4) Gammarus pseudolimnaeus 41% 62 (40-98)

Chironomus plumosus 41% 18 (9.4-32)
Daphnia pulex 51% MON

2139 242(224-

261.5) Daphnia magna 41.36% 5.3 (4.4-6.3) Gammarus pseudolimnaeus 41.83% 41.9 (30.7- 62) **Other results**  Ephemerella walkeri 41% Mayfly nymphs avoided glyphosate at concentratio ns of 10 mg/L but not at 1.0 mg/l.G LYPHOSATE RED September 1993

**Acute Toxicity to Freshwater Invertebrates Findings from Studies using Formulated Products** 

47 Chironomus plumosus 41% Significant increases in stream drift of midge larvae was observed after the 2.0 mg/l, but not at the 0.02 or 0.2 mg/l level. **Testing of an end-use product is required if the pesticide will be introduced directly into an aquatic**  **environment when used as directed by the label. Drainage systems (wet and dry) would be included in**  **such a category. Therefore, formulated product testing was required. According to the surfactant selected,**  **the formulated product toxicity ranges from moderately toxic to practically non-toxic. (Study ID 00078663, 00078666, 00078660, 00078657, 249160, 00108109, 00070893, and 249159)** 

**Surfactant Test Findings Species**  **% AI 48-hr LC**  **50 (95%CL)**  **Conclusions**

Daphnia magna 100%

MONO818 surfactant 13 mg/L

(7.1-24) slightly toxic to freshwater invertebrates

**Testing of the surfactant may be required under unusual circumstances. One test on the surfactant was**  **received and determined as acceptable for use in a risk assessment. (Study ID 249160)** (d) Summary of Findings

A 48-hour LC 50 of 780 ppm (mg/l) was found for Daphnia magnaexposed to technical glyphosate (McAllister and Forbis 1978, ID #00108172). The resultsof this study indicate that the chemical is practically non-toxic to aquatic invertebrates.
Inaddition to these acute studies, a fish lifecycle study indicates technical glyphosate has aG LYPHOSATE RED September 1993

48 MATC greater than 25.7 ppm. No effect was observed at the highest level tested. A Daphnia magna life cycle study with an MATC of >50 - <96 ppm reported reduced reproductive capacity, the most sensitive parameter. The available acute toxicity data indicate that precautionary labeling for freshwater intervertebrates is not required for products containing glyphosate.
Inorder to determine the effect of the three surfactants ("W", "AA", and "X-77") on invertebrates, additional Daphniastudies were conducted. The 7.03 percentisopropylamine salt of glyphosate with a surfactantat 0.5 percent identified as X-77 resulted in anLC 50 of greater than 1000 mg/l or practically nontoxiccategory for Daphnia . The second combination was 41.2 percent isopropylamine and 15.3 percent of a surfactant identified as "AA." This LC 50 was 310 ppm which would indicate it is practically non-toxic to Daphnia

. The third combination consisted of 40.7 percentisopropylamine and 15 percent of a surfactant identified as "W." The resultant LC 50 of 72 ppm reveals that this material is slightly toxic to Daphnia

. A glyphosate formulation was tested several times with different invertebrates. The LC 50 values ranged from 3 mg/l for Daphniato 62 mg/l for Gammarus

indicating a moderatelytoxic material for Daphniaand no more than slightly toxic for Gammarus

. (4) Effects on Marine/Estuarine OrganismsG LYPHOSATE RED September 1993

49 (a) Acute Toxicity

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

testing for estuarine and marine organism s on formulated glyphosate may be required when exposure to estuarine and marine water is expected. The use in

drainage systems (wet or dry) would allow this type of exposure. Minimum requirements are results from testing the technical on one estuarine fish (96 hrs LC 50 ) and either a 48 hrs oyster larvae study or a 96 hrs shell deposition study. Again, since there is such an extensive data set for thischemical, the Agency can determine that glyphosate demonstrates low toxicity to fish and oyster species, and therefore is waiving the marine fishand oyster acute toxicity studies on the formulated product.
**Acute Toxicity to Estuarine and Marine Organisms Findings Species**  **% AI Results**  **Conclusions** Grass shrimp 96.7%

tech LC 50281 ppm (207-381) ranges in toxicity from slightly to practically non-toxic to

marine organisms Fiddler crab 96.7%

tech LC 50934 ppm (555-1570) Atlantic oyster 96.7%

tech TL 50> 10 mg/L for 48 hours

**These data on marine/estuarine species are acceptable for use in a risk assessment. These data indicate**  **that technical glyphosate is practically non-toxic to grass shrimp, fiddler crab, and slightly toxic to the Atlantic** **oyster. Acute toxicity testing on an estuarine fish species is normally required. However, since ther**  **e is such an extensive data set for this chemical, the Agency can determine that glyphosate**G LYPHOSATE RED September 1993

50 **demonstrates low toxicity to fish species, and therefore is waiving the marine fish acute toxicity study.**  **(Study ID 00108110, and 00108111)** (b) Summary of Findings

A series of studies were performed on marine/ estuarine species. A 96-hour LC 50 of 281 ppm was de termined for grass shrimp ( Palaemonetas vulgaris). In a study on fiddler crabs ( Uca pugilator ), it was determined that the 96-hour LC 50 is 934 ppm glyphosate. Both of these studies indicate technical glyphosate is practically non-toxic to grass shrimp and fiddler crabs. An embryo-larvae 48-hour TL 50 for Atlanticoyster greater than 10 ppm indicating glyphosate is slightly toxic. (5) Effects on Non-Target Insects (a) Acute Toxicity Testing
**Acute Toxicity to Honeybees Data Species**  **AI % Results**  **Conclusions** Honeybee acute oral tech*CP67573 oral LD 50> 100μg/bee practically non-toxic to honeybees on an acute oral and

acute contact basis Honeybee acute oral 36 % MON2139 oral LD 50> 100μg/bee Honeybee acute contact tech*CP67573 contact LD 50> 100μg/bee Honeybee acute contact 36 % MON2139 contact LD 50> 100μg/bee * - The percentage of active ingredient used was not reported.

**The guidelines require acute toxicity testing to honeybees on the technical when a herbicide is registered**  **as a general use herbicide. Given the multitude of use patterns for which this chemical is registered,**  **acute honeybee toxicity studies are required. Based on these data, glyphosate (CP67573) is considered**  **practically nontoxic on the basis of acute contact toxicity, as well as on acute oral toxicity. These data**  **satisfy guideline requirements for nontarget insect studies when glyphosate is used as a general use**  **herbicide. (Fiche No. 00026489)**G LYPHOSATE RED September 1993

51 (b) Summary of Findings

Four studies were conducted, two on technical glyphosate and two on the formulation MON2139, consisting of 36 % active ingredient. Results from the honeybeeacute oral toxicity study indicates both technical and formulated glyphosate are practically nontoxic to the honey bee with LD 50 values greater than 100 μg/bee. Results from the honeybee acute contacttoxicity study indicates both technical and formulated glyphosate are practically nontoxic to the honey bee with LD 50 values greater than 100 μg/bee. (6) Effects to Non-Target Plants

When a herbicide is applied as a terrestrial nonfood use,aquatic nonfood use, or as a forestry use, Tier I nontarget phytotoxicity studies are required in order to evaluate the effects of the herbicide on nontarget plants. (a) Phytotoxicity Testing
**Effects on Non-Target Plant Findings Species**  **%AI Results** 
Selenastrum capricornutum 96.6 4 day EC 50= 12.5 mg/l Navicula pelliculosa 96.6 4 Day EC 50= 39.9 mg/l Skeletonema costatum 96.6 4 day EC 50= 0.85 mg/lAnabaena flosaquae 96.6 4 day EC 50= 11.7 mg/l
Lemna gibba 96.6 7 day EC 50= 21.5 mg/l

**Based on the results of the preceding studies, the data indicates that the 4 day EC**  **50 ranged from 0.85 mg/l**  **to 39.9 mg/l for four aquatic plant species, and a 7 day EC**  **50 of 21.5 mg/l for one aquatic species. Based** G LYPHOSATE RED September 1993

52 **on the data submitted, the requirements for Tier I and Tier II Aquatic Plant Growth Studies (122-2 and 123-2) have been fulfilled.** 
**A seed germination/seedling emergence study was conducted (MRID 40159301) on isopropylamine salt**  **of glyphosate CP-70139 (Tech) 50% acid basis. The results indicate that CP-70139 applied at a rate up**  **to 10.0 lb ai/A resulted in <25 % effect on the spectrum of monocots and dicots tested. Based on the**  **results of this study, Tier I data requirements for seed germination/seedling emergence guideline reference**  **122-1 have been satisfied. (MRIDs 40236901, 40236902, 40236903, 40236934, and 40236905)**  (b) Summary of Findings
Based on the results of the aquatic plant growth studies which were conducted on 5 species, the data indicates that the 4 day EC 50 ranged from 0.85 mg/l to 39.9 mg/l for four aquatic plant species, and a 7 day EC 50 of 21.5 mg/l for one aquatic species. A seed germination/seedling emergence study was conducted on isopropylamine salt of glyphosate CP-7 0139 (Tech) 50% acid basis. The results indicate that CP-70139 applied at a rate up to 10.0 lb ai/A resulted in <25 % effect on the spectrum of monocots and dicots tested. Based on the use patterns, the method of applicati on, and the chemical properties of glyphosate, additional studies are required to evaluate the effects on nontarget plants. The recommended labels do not preclude off-target movementof glyphosate by drift. Nor do they address the potential

off-target movement via terrestrial plants as well as aquatic plants. Therefore, the Agency is requiring terrestrial plant test data to assess potential riskto nontarget plants. The data required are the Tie r II Vegetative Vigor Guideline Reference No. 123- 1. In addition, droplet size spectrum (201-1) and drift field evaluation (202-1) data are required. Thesethree guideline studies, Vegetative Vigor , Droplet Size Spectrum, and Drift Field Evaluation are not considered partof the target data base for reregistration. These data do not affect theG LYPHOSATE RED September 1993

53 reregistration eligibility of glyphosate. If, upon review of the data from these studies, modification in use practices and/or precautionary measures are nece ssary, the Agency will require all registrants to make label changes as appropriate. b. Ecological Effects Risk Assessment

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

T he acute oral LD 50 found for bobwhite quail dosed with technical

glyphosate is greater than 3851 mg/kg. This indicates that the chemical is practically non-to xic to an upland game species. On a dietary basis, the available data indicate that, at most, technical glyphosate is slightly toxic to both mallards and bobwhite (LC 50 > 4640). The articles of Hoerger and Kenaga (1972) and Kenaga (1973) were consulted in order to estimate the maximum concentration

of glyphosate which may occur at the highest application rate for such sites as, cotton and corn. The following chart addresses the major vege tation categories upon which fauna are expected to feed.
**Feed Category Concentrations (ppm)**

**@ 5.0625 lbs ai/A** Short grass 1215G LYPHOSATE RED September 1993

54 Long grass 557 Leafy crops 632 Forage; small insects 294 Pods; large insects 61 Fruit 35
Comparing these residues to the dietary data for both bobwhite and mallards (LC 50 > 4640; 1/5th the LC 50 > 928), higher use rates may produce potentially toxic residues on short grass only (assumin g the LC 50 is just over > 4640). Wildlife ingesting significantamounts of insects, pods and/or fruits should not be affected by single applications. Directions for some of the use patterns do indicate that applications can be repeated.Multiple treatments could potentially increase residues on dietary items within an extended time period. Also, the available information suggest that glyphosate is relatively persistent. The half-life in soil is as high as 90.2 days. However, avian reproduction studies demonstrated no adverse effects at the highestlevel tested, 1000 parts per million. Similarly, 90-day dietary studies with dogs and rats indicate no significant abnormalities when the maximum level tested is 2000 parts per million. Based on this, minimal risk is expected.G LYPHOSATE RED September 1993

55 (b) Aquatic Species

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

A seed germination/seedling emergence study was conducted on

isopropylamine salt of glyphosate CP-70139 (Tech) 50% acid basis. The results indicate that CP-70139 applied at a rate up to 10.0 lb ai/A resulted in <25 % effect on the spectrum of monocots and dicots tested. Considering the use patterns that are terrestrial food crop and non-food crop the above EEC's were considered for evaluating the effectsto nontarget plants. The highest exposure of 0.404 lb a.i. (from aerial application, mist blower and sprinkler irrigation) is well below the 10.0 lb a.i./A rate which resulted in < 25 % effect on the monocots and dicots tested. Therefore, it has been determined that the use of glyphosate is not expected to cause adverse effects on seed germination/seedling emergence with the various registered use patterns. (MRID 40159301) No vegetative vigor (123-1) plant studies have beenconducted. Based on the use patterns, the method of application and the chemical properties ofG LYPHOSATE RED September 1993

56 glyphosate,additional studies are required to evaluate these effects on nontarget terrestrial plants. The recommended labeling precautions do not preclude off-target movement of glyphosate by drift. To assess potential risk to terrestrial plants the Agency is requiring additional terrestrial plant test data, including results from vegetative vigor testing, droplet size spectrum testing and drift field evaluation. Thesedata are not part of the target data base for reregistration. Risk reduction measures cannot be recomm ended until data are submitted and evaluated. If, upon review of the data from these studies, modifica tion in use practices and/or precautionary measures are necessary, the Agency will require all registrants to make label changes as appropriate. The aquatic EEC from direct application of 3.72 ppm was used to estimate exposure. Based on the results of the aquatic macrophyte toxicity data, the 4 day EC 50 was reported to be as low as 0.85 ppm indicating that there may be adverse effects to nontarget aquatic plant species. (2) Endangered Species

Based on the toxicity data and the estimated exposure,it is not expected that endangered terrestrial or aquaticorganisms will be affected from the use of glyphosate onthe registered uses since the EEC's are well below the endanger ed species criteria (birds= 1/10 LC 50 , aquatic organisms= 1/20 LC 50 ). However, many endangered plants may be at risk from the use of glyphosate on the registered use patterns. In addition, as discussed in the 1986 Glyphosate Registration Standard, it was determined that based on habitat, the Houston Toad may be at risk from the use of glyphosate on alfalfa. 

### IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of EligibilityG LYPHOSATE RED September 1993

57

Section4(g)(2)(A) of FIFRA calls for the Agency to determine, after submissionof relevant data concerning an active ingredient, whether products containing the active ingredients are eligible for reregistration. The Agency has previously

identified and required the submission of the generic (i.e. active ingredientspecific) data required to support reregistration of products containing glyphosate active ingredients. The Agency has completed its review of these genericdata, and has determined that the data are sufficient to support reregistrationof all products containing the isopropylamine and sodium salts of glyphosate. Appendix B identifies the genericdata requirements that the Agency reviewed as part of

its determination of reregistration eligibility of glyphosate, and lists the submitted studies that the Agency found acceptable. The data identified in Appendix B were sufficient to allow the Agency to assess the registered uses of glyphosate and to determine that glyphosate can be used without resulting in unreasonable adverse effects to man and the environment. The Agency therefore finds that all products containing glyphosate as the active ingredients are eligible for reregistration. The reregistration of particular products is addressed in Section V of this document.
The Agency made its reregistration eligibility determination based upon the target data base required for reregistration, the current guidelines for conducting acceptable studies to generate such data and the data identified in Appendix B. Although the Agency has found that all uses of glyphosate (isopropylamine and sodium salt formulations) are eligible for reregistration, it should be understood that the Agency may take appropriate regulatory action, and/or require the submission of additional data to support the registration of products containing glyphosate, if new information comes to the Agency's attention or if the data requirements for registration (or the guidelines for generating such data) change.
1. Eligibility Decision

Based on the reviews of the generic data for the active ingredient glyphosate,the Agency has sufficient information on the health effects of glyphosate and on its potential for causing adverse effects in fish and wildlife and the environment. The Agency concludes that products containing glyphosate for all uses are eligible for reregistration. The Agency hasdetermined that glyphosate products, labeled and used as specified in this Reregistration Eligibility Document, will not pose unreasonable risks or adverse effects to humans or the environment.G LYPHOSATE RED September 1993

58

2. Eligible and Ineligible Uses

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

The following is a summary of the regulatory positions and rationales for glyphosate. Where labeling revisions are imposed, specificlanguage is set forth in Section V of this document.
1. Tolerance Re-assessment

The Agency has determined that aminomethyl phosphonic acid (AMPA), the metabolite of glyphosate, no longer needs to be regulated and therefore this compound will be dropped from the tolerance expression. Also, although the monoammonium salt of glyphosate is not subject to reregistration, the available data are to allow re-assessment of existing tolerances for residues resulting from the application of the monoammonium salt of glyphosate. Tolerances Listed Under 40 CFR §180.364(a):
The toleranceslisted in 40 CFR §180.364(a) are for the combined residues of glyphosate and its metabolite AMPA resulting from application of the isopropylamine saltof glyphosate and/or the monoammonium salt of glyphosate. Sufficientdata are available to ascertain the adequacy of the established tolerances listed in 40 CFR §180.364(a) for: acerola; alfalfa, forage, seed, and hay; almonds, hulls; artichokes, Jerusalem; asparagus; a temoya; avocados; Bahiagrass; bananas; beets, garden, roots; Bermudagrass; bluegrass; Brassica leafy vegetables group; bromegrass; bulb vegetables group; carambola; carrots; cereal grains group; citrus fruits group;coffee beans, green; clover; cotton forage; cotton hay; cottonseed; cranberries; cucurbit vegetables group; fescue; figs; foliage of legume vegetables group; fruiting vegetables group; grapes; grass forage, fodder, and hay group; guavas; horseradish; kiwifruit; leafy vegetables group; leavesof the root and tuber vegetables group; legume vegetables group; longan fruit; lychee; mangoes; non-grass animal feeds group, forage and hay; orchardgrass; papayas; parsnips; passion fruit; peanuts; peanuts,G LYPHOSATE RED September 1993

59

vines; pineapple; pistachio; pome fruits group; radishes; rutabagas; ryegrass; sapodilla; sapote; small fruits and berries group; soybeans; soybean, forage; stone fruits group; sugar apple; sugar beets; sweet potatoes; timothy; tree nuts group; turnip roots; wheatgrass; and yams. Certaincommodity definitions of the above tolerances are not in accordance with the definitions listed in Table II of Subdivision O; see the tolerance re-assessment table on page 63 for modifications in commodity definitions. The established crop group tolerances for the now-obsolete "seed and pod vegetables" (0.2 ppm) and "seed and pod vegetables, forage and hay" (0.2 ppm) are inappropriate and are to be replaced with "legume vegetables group (except soybeans)" and "legume vegetables group, foliage of (except soybean forage and hay)," respectively. Soybeans must be excluded from the crop group tolerances because the use pattern for soybeans is different from other legume vegetables, and the established tolerance for soybeans and soybean forage and hay differ by a factor >5x from other legume vegetables. To achieve compatibility with Codex MRLs for selected commodities, the following actions must be taken (see the table onpage 68): (i) increase U.S. tolerance for legume vegetables group (except soybeans) from 0.2 ppm to 5 ppm; and (ii) increase U.S. tolerance for soybean hay from 15 ppm to 20 ppm. The individual tolerances for cranberries (0.2 ppm) and grapes (0.2 ppm) should be revoked since these fruits are covered by the crop group tolerance (0.2 ppm) for small fruits and berries. The tolerance for cotton hay is to be revoked since this is not a raw agricultural commodity of cotton.G LYPHOSATE RED September 1993

60 Tolerances for wheat, grain and wheat, straw at 4 and 85 ppm, respectively, have been proposed (PP0F3865/FAP2H5635). When these tolerances have been established, the tolerances for the cereal grains group and the cereal grains group, forage, fodder, and straw should be modified to "cereal grains group (except wheat)" and "cereal grains group, forage, fodder, and straw (except wheat straw)", respectively. To achieve compatibility

with the Codex MRL for wheat grain, the U.S. tolerance should be established at 5 ppm (see the table on page 68). The existing and conflicting tolerances for alfalfa (200 ppm), alfalfa fresh and hay (0.2 ppm), clover (200 ppm), and forage legumes (except soybeans and peanuts; 0.4 ppm) should be deleted. Concomitant with the deletion of these tolerances, a tolerance of 100 ppm for residues in or on the non-grass animal feeds group, forage and hay, is to be established. The available data from alfalfa, lespedeza, and trefoil will support this crop group tolerance. The established tolerances for "forage grasses" (0.2 ppm), "grasses, forage" (0.2 ppm), Bahiagrass (200 ppm), Bermudagrass (200 ppm), bluegrass (200 ppm), bromegrass (200 ppm), fescue (200 ppm), orchardgrass (200 ppm), ryegrass (200 ppm), timothy (200 ppm), and wheatgrass (200 ppm) is to be deleted.Concomitant with the deletion of these tolerances, a tolerance for residues in on or on the grass forage, fodder, and hay group is to be established at 100 ppm. The available data indicate that following registered use, residues in or on the grass forage, fodder, and hay group will not exceed 100 ppm. Individual tolerances exist for residues in or on salsify and the following tropical/subtropical crops: breadfruit; canistel; cherimoya; cocoa beans; coconut; dates; genip; jaboticaba; jackfruit; persimmons; sapote (black and white); soursop; and tamarind. There are currently no registered uses of glyphosate on these crop sites. These tolerances will be revoked.
A tolerance of 200 ppm has recently been established for residues in or on soybean straw (FR 42701,9/16/92). However, this tolerance is to be revoked since this is not a raw agricultural commodity of soybeans. The tolerance for soybeans, hay should be raised to cover this desiccant use. The expression negligible residues (N) should be deleted. For a complete listing of appropriate commodity definition changes and recommendations, see the table on page 63.G LYPHOSATE RED September 1993

61

Tolerances Listed Under 40 CFR §180.364(b):
The tolerances listed in 40 CFR §180.364(b) are for the combined residues of glyphosate and its metabolite AMPA resulting from application of the glyphosate isopropylamine salt and/or glyphosate monoammonium salt for herbicidal and plant growth regulator purposes and/or the sodium sesqui salt for plant regulator purposes. Sufficientdata are available to ascertain the adequacy of the established tolerances listed in 40 CFR §180.364(b) for: liver and kidney of cattle, goats, hogs, horses, poultry, and sheep; peanuts; peanuts, hay; peanuts, hulls; sugarcane; fish; and shellfish. See the table on page 63 for modifications in commodity definitions. Tolerances Listed Under 40 CFR §180.364(c): The tolerances listed in 40 CFR §180.364(c) are for the combined residues of glyphosate and its metabolite AMPA resulting from the use of irrigationwater containing residues of 0.5 ppm following applications on or around aquatic sites, and are established at 0.1 ppm. The Agency's Office of Water has established a maximum contaminant level (MCL) of 0.7 ppm for glyphosate per se

in drinking water (FR Notice: Vol. 57, No. 138, page 31776, dated July 17, 1992). Sufficientdata are available to ascertain the established tolerances liste d in 40 CFR §180.364(c) for the crop groupings Brassica leafy vegetables group; bulb vegetables group; cereal grains group; citrus fruits grou p; cucurbit vegetables group; foliage of legume vegetables group; forage, fodder, and straw of the cereal grains group; fruiting vegetables group;grass forage, fodder and hay group; leafy vegetables group; leaves ofthe root and tuber vegetables group; legume vegetables group; nongr ass animal feeds group, forage and hay; pome fruits group; root and tuber vegetables group; stone fruits group; tree nuts group; and the individual commodities avocados, cottonseed, and hops. See the table on page 63 for modifications in commodity definitions. Tolerances Listed Under 40 CFR §185.3500:
The tolerances listed in 40 CFR §185.3500(1) are for the combined residues of glyphosate and its metabolite AMPA resulting from theG LYPHOSATE RED September 1993

62

applicationof the glyphosate for herbicidal purposes and/or the sodium sesqui salt for plant regulator purposes. Sufficientdata are available to ascertain the adequacy of the established food additive tolerances listed in 40 CFR §185.3500(1) for sugarcane,molasses. See the table on page 63 for modifications in commodity definitions. The tolerances listed in 40 CFR §185.3500(2) are for the combined residues of glyphosate and its metabolite AMPA resulting from the applicationof the isopropylamine salt of glyphosate for herbicidal purposes. Sufficientdata are available to ascertain the adequacy of the est ablished food additive tolerances listed in 40 CFR §185.3500(2) for olives (imported), palm oil, dried tea and instant tea. See the table on page 63 for modifications in commodity definitions.
A 12-ppm food additive tolerance for wheat milling fractions (except flour) has been proposed (FAP2H5635). To achieve compatibility with the Codex MRL for wheat bran, unprocessed, the U.S. tolerance should be established at 40 ppm (see the table on page 68). Tolerances Listed Under 40 CFR §186.3500:
The tolerances listed in 40 CFR §186.3500(a) are for the combined residues of glyphosate and its metabolite AMPA. Sufficientdata are available to ascertain the adequacy of the establish ed feed additive tolerances listed in 40 CFR §186.3500(a) for dried citrus pulp and soybean hulls. See the table on page 63 for modifications in commodity definitions.
A tolerance has recently been established at 1.0 ppm for the combined residues of glyphosate and AMPA in citrus, molasses (FR 42701, 9/16/92).
Existing tolerances of glyphosate are currently established in the Title 40 of the Code of Federal Regulations, §180.364. The reassessment of the established tolerances is set forth in the Tolerance Reassessment Table as follows.G LYPHOSATE RED September 1993

63

Commodity Current Tolerance 1 (ppm) Tolerance 2

Reassessment (ppm) Comment/ Correct Commodity Definition
**Tolerances listed under 180.364(a):** Acerola 0.2 Alfalfa Alfalfa, fresh and hay Clover Forage legumes (except soybeans and peanuts) 200.0 0.2 200.0 0.4 Revoke and establish at 100 Non-grass animal feeds

group, forage and hay

Almond hulls 1 Almonds, hulls Artichokes, Jerusalem 0.2 Asparagus 0.5 Atemoya 0.2 Avocados 0.2 Bahiagrass Bermudagrass Bluegrass Bromegrass Fescue Forage grasses Grasses, forage Orchardgrass Ryegrass Timothy Wheatgrass 200.0 200.0 200.0 200.0 200.0 0.2 0.2 200.0 200.0 200.0 200.0 Revoke and establish at 100 Grass forage, fodder, and

hay group

Bananas 0.2 Beets 0.2 Beets, garden, roots Beets, sugar 0.2 Sugar beets Breadfruit 0.2 Revoke No registered uses Canistel 0.2 Revoke No registered uses Carambola 0.2 Carrots 0.2 Cherimoya 0.2 Revoke No registered uses Chicory 0.2 Chicory, roots Citrus fruits 0.2 Citrus fruits group Cocoa beans 0.2 Revoke No registered uses Coconut 0.1 Revoke No registered uses Coffee beans 1 Coffee beans, green Cotton, forage 15G LYPHOSATE RED September 1993

Commodity Current Tolerance 1 (ppm) Tolerance 2

Reassessment (ppm) Comment/ Correct Commodity Definition

64 Cotton, hay 15 Revoke Not in Table II, Subdivision O, PAG Cottonseed 15 Cranberries 0.2 Revoke Covered under small fruits and berries group Dates 0.2 Revoke No registered uses Figs 0.2 Forage grasses Grasses, forage 0.2 0.2 0.2 Forage, fodder, and straw of cereal grains group (except wheat straw) Fruits, small and berries 0.2 Small fruits and berries group Genip 0.2 Revoke No registered uses Grain crops 0.1 Cereal grains group (except wheat) Grapes 0.2 Revoke Covered under small fruits and berries group Guavas 0.2 Horseradish 0.2 Jaboticaba 0.2 Revoke No registered uses Jackfruit 0.2 Revoke No registered uses Kiwifruit 0.2 0.1 see Codex Harmonization Table Leafy vegetables 0.2 Leafy vegetables (except Brassica) group

and Leaves of root and tuber vegetables group Longan 0.2 Longan fruit Lychee 0.2 Mamy sapote 0.2 Sapote Mangoes 0.2 Nuts 0.2 Tree nuts group Olives 0.2 Papayas 0.2 Parsnips 0.2 Parsnips, roots Passion fruit 0.2 Peanut, forage 0.5 Peanuts, vines Persimmons 0.2 Revoke No registered usesG LYPHOSATE RED September 1993

Commodity Current Tolerance 1 (ppm) Tolerance 2

Reassessment (ppm) Comment/ Correct Commodity Definition

65 Pineapple 0.1 Pineapples Pistachio nuts 0.2 Pistachios Pome fruits 0.2 Pome fruits group Potatoes 0.2 Radishes 0.2 Radishes, root Rutabagas 0.2 Rutabagas, root Salsify 0.2 Revoke No registered uses Sapodilla 0.2 Sapote, black 0.2 Revoke No registered uses Sapote, white 0.2 Revoke No registered uses Seed and pod vegetables 0.2 5 see Codex harmonization Table; Legume vegetables group (except soybeans) Seed and pod vegetables, forage Seed and pod vegetables, hay 0.2
0.2 0.2 Foliage of legume vegetables group (except soybean forage and hay) Soursop 0.2 Revoke No registered uses Soybeans 20 Soybeans, forage 15 Soybeans, hay 15 200 Raised to cover desiccant use. Soybeans, straw 200 Revoke Not in Table II, Subdivision O, PAG Stone fruit 0.2 Stone fruits group Sugar apple 0.2 Sweet potatoes 0.2 Tamarind 0.2 Revoke No registered uses Turnips 0.2 Turnips, roots Vegetables, bulb 0.2 Bulb vegetables group Vegetables, cucurbit 0.5 Cucurbit vegetables group Vegetables, fruiting (except cucurbits) group 0.1 Fruiting vegetables group Vegetables, leafy, Brassica (cole) 0.2 Brassica leafy vegetables group Yams 0.2 Wheat, grain N/A 5.0 see Codex harmonization Table Wheat, straw N/A 85 (proposed)G LYPHOSATE RED September 1993

Commodity Current Tolerance 1 (ppm) Tolerance 2

Reassessment (ppm) Comment/ Correct Commodity Definition

66 **Tolerances listed under 40 CFR §180.364(b):** Cattle, kidney 0.5 2.0 see Codex harmonization Table Cattle, liver 0.5 2.0 see Codex harmonization Table Fish 0.25 Goats, kidney 0.5 Goats, liver 0.5 Hogs, kidney 0.5 1.0 see Codex harmonization Table Hogs, liver 0.5 1.0 see Codex harmonization Table Horses, kidney 0.5 Horses, liver 0.5 Peanuts 0.1 Peanut, hay 0.5 Peanuts, hay Peanut, hulls 0.5 Peanuts, hulls Poultry, kidney 0.5 Poultry, liver 0.5 Sheep, kidney 0.5 Sheep, liver 0.5 Shellfish 3.0 Sugarcane 2.0 **Tolerances listed under 40 CFR 180.364(c):** Avocados 0.1 Citrus 0.1 Citrus fruits group Cottonseed 0.1 Cucurbits 0.1 Cucurbit vegetables group Forage grasses 0.1 Grass forage, fodder, and hay group Forage legumes 0.1 Non-grass animal feeds group, forage and hay Fruiting vegetables 0.1 Fruiting vegetables group Grain crops 0.1 Cereal grains group and Forage, fodder, and straw of cereal grains group Hops 0.1G LYPHOSATE RED September 1993

Commodity Current Tolerance 1 (ppm) Tolerance 2

Reassessment (ppm) Comment/ Correct Commodity Definition

67 Leafy vegetables 0.1 Leafy vegetables (except Brassica) group

and Brassica (cole) leafy vegetables group Nuts 0.1 Tree nuts group Pome fruits 0.1 Pome fruits group Root crop vegetables 0.1 Root and tuber vegetables group and Leaves of root and tuber vegetables group

and Bulb vegetables group Seed and pod vegetables 0.1 Legume vegetables group and Foliage of legume vegetables group Stone fruit 0.1 Stone fruits group
**Tolerances listed under 40 CFR §185.3500(a)(1):** Molasses, sugarcane 30.0 Sugarcane, molasses **Tolerances listed under 40 CFR §185.3500(a)(2):** Oil, palm 0.1 Palm oil, refined Olives, imported 0.1 Tea, dried 1.0 Tea, instant 7.0 Revoke Not in Table II, Subdivision O, PAG Wheat milling fractions (except flour) N/A 40 see Codex harmonization Table

**Tolerances listed under 40 CFR §186.3500(a):** Citrus, pulp, dried 1.0 Citrus molasses 1.0 Citrus, molasses Soybean hulls 100 Soybeans, hulls 1 Tolerances are for the combined residues of glyphosate and its metabolite AMPA. 2 Tolerances are now for glyphosate per se .68 CODEX HARMONIZATION TABLE Severalmaximum residue limits (MRLs) for glyphosate have been established by Codex in various commodities. The Codex MRLs (currently expressed in terms of glyphosate per se) and applicable U.S. tolerances (expressed in terms of the combined residues of glyphosate and its metabolite AMPA) are listed in the table below. The Agency has determined that AMPA no longer needs to be regulated and therefore will be deleted from the tolerance expression. Based on this determination, the expressionof the U.S. tolerances and the Codex MRLs will be harmonized, and both will now be expressed in terms of glyphosate per se

. Codex MRLs and applicable U.S. tolerances. Recommendations for compatibility

are based on conclusions following reassessments of U.S. tolerances (see Tolerance Reassessment Table, above).

Commodity MRL (Step) (mg/kg) U.S. Tolerance (ppm) Recommendation
Barley 20 (CXL) 0.1 (Cereal grains group, except wheat) Beans (dry) 2 (CXL) 0.2 (Legume vegetables group, except soybeans) Cattle meat 0.1 (CXL) Cattle milk 0.1 (CXL) Cattle, edible offal 2 (CXL) 0.5 (Cattle, liver & kidney) increase U.S. tolerances Cottonseed 0.5 (CXL) 15
Eggs 0.1 (CXL) Hay or fodder (dry) of grasses 50 (CXL) 100 (Grass forage, fodder, and hay group) Kiwifruit 0.1 (CXL) 0.2 decrease U.S. tolerance

Maize 0.1 (CXL) 0.1

Oats 20 (CXL) 0.1 (Cereal grains group, except wheat) Peas (dry) 5 (CXL) 0.2 (Legume vegetables group, except soybeans) increase U.S. tolerance Pig meat 0.1 (CXL) Pig, edible offal 1 (CXL) 0.5 (Hogs, liver & kidney) increase U.S. tolerances Poultry meat 0.1 (CXL) Rape seed 10 (CXL) Rice 0.1 (CXL) 0.1 (Cereal grains group, except wheat)Commodity MRL (Step) (mg/kg) U.S. Tolerance (ppm) Recommendation

69 Sorghum 0.1 (CXL) 0.1 (Cereal grains group, except wheat)
Soya bean fodder 20 (Step 8) 15 (Soybeans, hay) Soya bean forage (green) 5 (Step 8) 15 (Soybeans, forage) Soya bean (dry) 5 (Step 8) 20 (Soybeans) Soya bean (immature seeds) 0.2 (CXL) Straw and fodder (dry) of cereal grains 100 (CXL) 0.2 (Forage, fodder, and straw of cereal grains group, except wheat straw) Sweet corn (corn-on-the-cob) 0.1 (CXL) 0.1 (Cereal grains group, except wheat)

Wheat 5 (CXL) 4 (proposed) increase U.S. tolerance proposal Wheat bran, unprocessed 40 (Step 6) 12 (proposed) increase U.S. tolerance proposal Wheat flour 0.5 (Step 8) Wheat whole meal 5 (Step 8) 12 (proposed)

The following conclusions can be made regarding efforts to harmonize the U.S. tolerances with the Codex MRLs: 

### Ë Compatibility

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

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

### Ë The level of the U.S. tolerance should be decreased to achieve compatibility

with the Codex MRLs in or on kiwifruit (from 0.2 to 0.1 ppm). 

### Ë The U.S. tolerances in or on the following commodities were based on registered use patterns in the U.S. and cannot be lowered to achieve compatibility

with the Codex MRLs: (i) grass forage, fodder, and hay group; (ii) soybeans; and (iii) soybeans, forage. 

### Ë Wh eat grain and wheat bran tolerances of 4 and 12 ppm, respectively, have been proposed. To achieve compatibility with Codex, these tolerance levels should be increased, toxicological and DRES considerations permitting, to 5 and 40 ppm, respectively.70 

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

### Ë No questions of compatibility exist with respect to commodities where: (i) no Codex MRLs have been established, but U.S. tolerances exist; and (ii) Codex MRLs have been established, but U.S. tolerances do not exist.
2. Labeling Rationale

While studies show

that glyphosate is no more than slightly toxic to birds and is practically

non-toxic to fish and honeybees, a toxic inert in glyphosate end use products necessitates the labelling of some products "toxic to fish" since some glyphosate products are applied directly to aquatic environments.
3. Endangered Species Statement

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

### V. ACTIONS REQUIRED BY REGISTRANTS
Thissection specifies the data requirements and responses necessary for the reregistration of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements71 The generic data base supporting the reregistration of glyphosate for the above eligible uses has been

reviewed and determined to be substantially complete. The Agency will be calling in data on processed potatoes in a separate DCI. However, the following additional generic data are required at this time. These additional generic data are not part of the target data base for glyphosate and do not affect the reregistration eligibility of glyphosate. (See Appendices for the Generic Data Call-In Notice.)
**Name of Study Guideline Number** 

Tier II Vegetative Vigor 123-1 Droplet Size Spectrum 201-1 Drift Field Evaluation 202-1

2. Labeling Requirements for Manufacturing-Use Products Effluent Discharge Labeling Statement
All manufacturing-use or end-use products that may be contained in an effluent discharged to the waters of the United States or municipal sewer systems must bear the following revised effluent discharge labeling statement. "Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans or other waters unless in accordance with the requirements of a National Pollutant Discharge Elimination System (NPDES) permit and the permitting authority has beennotified in writing prior to discharge. Do not discharge effluent containing this product to sewer systems without previously notifying the local sewage treatment plant authority. For guidance contact your State Water Board or Regional Office of the EPA." All affected products distributed or sold by registrants and distributors (supplemental registrants) must bear the above labeling by October 1, 1995. All products distributed or sold by persons other than registrants or supplemental registrants after October 1, 1997 must bear the correct labeling. Refer to PR Notice 93-10 or 40 CFR 152.46(a)(1) for additional information.
B. End-Use Products
1. Additional Product-Specific Data Requirements

Section 4(g)(2)B) of FIFRA calls for the Agency to obtain any needed productspecific data regarding the pesticide after a determination of eligibility has been72 made. The product specific data requirements are listed in Appendix G, the Product Specific Data Call-In Notice. Registrants must review previous data submissions to ensure that they meet current EPA acceptance criteria (Appendix F; Attachment E) and if not, commit to conductnew studies. If a registrant believes that previously submitted data meet current testing standards, then study MRID numbers should be cited according to the instructions in the Requirement Status and Registrants Response Form provided for each product.
2. Labeling Requirements for End-Use Products

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

a. Nonaquatic

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

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

c. Worker Protection Standard Compliance Any product whose labeling reasonably permits use in the commercial or researchproduction of an agricultural plant on any farm, forest, nursery, or greenhouse must comply with the labeling requirements of PR Notice 93-7, "Labeling Revisions Required by the Worker Protection Standard (WPS), and PR Notice 93-11, "Supplemental Guidance for PR Notice 93-7," which reflect the requirements of EPA's labeling regulations for worker protection statements (40 CFR part 156, subpart K). These labeling revisions are necessary to implementthe Worker Protection Standard for Agricultural Pesticides (40 CFR Part 170) and must be completed in accordance with, and within the deadlines73 spe cified in, PR Notices 93-7 and 93-11. Unless otherwise specifically directed inthis RED, all statements required by PR Notices 93-7 and 93-11 are to be on the product labeling exactly as instructed in those notices. After April 21, 1994, except as otherwise provided in PR Notices 93-7 and 93-11, all products within the scope of those notices must bear WPS PR-Noticecomplying labeling when they are distributed or sold by the primary registrant or any supplementally registered distributor. After October 23, 1995, except as otherwise provided in PR Notices 93-7 and 93-11, all products within the scope of those notices must bear WPS PRNotice-complying labeling when they are distributed or sold by any person. Personal Protective Equipment Do not add any additional personal protective equipment requirements to the labels of glyphosate end-use products, however, any existing personal protective equipment on those labels must be retained. Entry Restrictions Products not Primarily Intended for Home Use
Uses Within the Scope of the WPS: A 12-hour restricted entry interval (REI) is required for all uses within the scope of the WPS (see PR Notice 93-7) on all end-use products, except those intended primarily for home use (see tests in PR Notice 93-7 and 93-11). This REI should be inserted into the standardized REI statementrequired by PR Notice 93-7. The personal protective equipment for early entry should be the PPE required for applicators of glyphosate, except any applicator requirementfor an apron or respirator is waived. This PPE should be inserted into the standardized early entry PPE statement required by PR Notice 93-7." Sole-active-ingredient end-use products that contain glyphosate must be revised to adopt the entry restrictions set forth in this section. Any conflicting entry restrictions on their current labeling must be removed. Multiple-active-ingredient end-use products that contain glyphosate must compare the entry restrictions set forth in this section to the entry restrictions on their current labeling and retain the more protective. A specific time-period in hours or days is considered more protective than "sprays have dried" or "dusts have settled."74 U ses Not Within the Scope of the WPS : Do not add any additional entry restrictions for uses not within the scope of the WPS, however, any entry restrictions on the current product labeling for those uses must be retained. Products Primarily Intended for Home Use: For products primarily intended for home use (see tests in PR Notice 93-7 and 93-11), do not add any additional entry restrictions for such products, however, any entry restrictions on the current product labeling must be retained. C. Existing Stocks

Registrant s may generally distribute and sell products bearing old labels/labeling for 26 months from the date of the issuance of this RED. Persons other than the registrant may

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

### VI. APPENDICES75

1. **Bolded** references were reviewed on 4/26/90. Unbolded references were reviewed in the Residue Chemistry Science Chapter of the Reregistration Standard dated 7/15/85. Otherwise, references were reviewed as noted.