Comments of Monsanto Company for

EPA FIFRA SAPReview of Glyphosate

PRESENTED BY:Donna Farmer, PhDSenior Toxicologist, Monsanto CompanyDecember 13-16, 2016

Experts to Review and Address EPA’s Charge Questions

Name Affiliation Title Topic

Donna Farmer, Ph.D.Monsanto

CompanySenior Toxicologist Opening Remarks

Caroline Harris, Ph.D. Exponent

Corporate Vice President,

Center Director and Principal

Scientist

Dietary Exposure

John Acquavella, Ph.D.,

FACE, FISPE

Aarhaus

University

Professor, Department of

Clinical EpidemiologyEpidemiology (Q2)

James Bus, Ph.D., DABT,

ATSExponent Senior Managing Scientist Animal Bioassay (Q3)

Joseph Haseman, Ph.D.J.K. Haseman

ConsultingPresident Biostatistics

David Kirkland, Ph.D.Kirkland

Consulting

Genetic Toxicology ConsultantGenotoxicity (Q4)

Rick Reiss, Sc.D. ExponentGroup Vice President and

Principal Scientist

Carcinogenicity

Classification (Q5) &

Closing Remarks

40 Year History of Safe Use

3

• Key Factors in the adoption

of glyphosate-based

herbicides

- Broad spectrum of weeds

- Benefits

- Safety profile

How Glyphosate Works in the Plant

Glyphosate inhibits an enzyme

present in plants that people

and animals do not produce

Glyphosate is applied to a plant,

absorbed and travels to the roots

where it blocks this specific plant

enzyme

Glyphosate is not an

organophosphate and does not

inhibit cholinesterase activity

Agricultural Biotechnology

5

Glyphosate-tolerant Crops

Corn Cotton Soybean

Benefits: Conservation Tillage

6

Benefits: Other Crop Uses

7

Orchards

Vineyards

Cover Crops

Benefits: Non-Agricultural Uses

8

Roadways Railways Utilities

Waterways

40 Year History of Safe Use

Glyphosate is supported by one of the most

extensive worldwide human health and

environmental effects databases ever

compiled for a pesticide product

7 Complete Regulatory Data Packages

• Have consistently concluded that comprehensive

toxicology studies demonstrate that glyphosate:

- Has low oral, dermal and inhalation toxicity

- Is not:

• genotoxic

• neurotoxic

• immunotoxic

• an endocrine disruptor

• reproductive or developmental toxic

- does not produce malformations

Regulatory Reviews over 40 Years

10

Regulatory Reviews over 40 Years

Have consistently

concluded that

glyphosate is not a

carcinogenic hazard

to humans

2016 US EPA Registration Rev. Issue Paper (ongoing)

2016 Australia APVMA

2016 New Zealand EPA

2016 WHO/JMPR

2016 Japan FSC

2015 US EPA CARC Report

2015 EU Annex I Renewal (BFR; draft)

2015 Canada PMRA Registration Rev. (draft published)

2013 Australia

2012 US EPA Human Health RA

2008 US EPA Effects Determination

2007 Brazil ANVISA (pending)

2007 OEHHA

2005 WHO/Water Sanitation Health

2004 WHO/JMPR

2002 EU Annex I

2000 FAO Specifications

1999 Japan FSC

1994 WHO/IPCS

1993 US EPA RED

1991 Canada PMRA

1987 WHO/JMPR

Country Activity/Review Outcome Completion

US EPA’s OPP Glyphosate Issue Paper - Evaluation

of Carcinogenic Potential

Glyphosate is “not likely to be carcinogenic to

humans”Sept 2016

Australia Australian Pesticides and Veterinary Medicines

Authority (APVMA) evaluation of the IARC

monograph and other international assessments

(JMPR, EFSA, ECHA and New Zealand)

Glyphosate does not pose a cancer risk to humans Sept 2016

New

Zealand

Review of the Evidence Relating to Glyphosate

and Carcinogenicity

Glyphosate is unlikely to be genotoxic or

carcinogenic to humansAug 2016

JMPR Joint Food and Agriculture Organization (FAO)

and World Health Organization (WHO) Meeting -

Review of Carcinogenicity

Glyphosate is unlikely to pose a carcinogenic risk

to humans from exposure through the dietMay 2016

Japan Food Safety Commission (FSC) reviewed

glyphosate acceptable daily intake (ADI)

No neurotoxicity, carcinogenicity, reproductive

effect, teratogenicity or genotoxicity was observedMar 2016

EU European Food Safety Authority (EFSA) Renewal

Assessment Report and Proposed Decision

Glyphosate is unlikely to pose a carcinogenic

hazard to humans and is not proposed to be

classified as carcinogenic under the EU regulations

for classification, labelling and packaging

Nov 2015

US EPA’s Cancer Assessment Review Committee

(CARC) - Evaluation for Carcinogenic Potential

Glyphosate is classified as “not likely to be

carcinogenic to humans”Oct 2015

US EPA’s Endocrine Disruptor Screening Program

(EDSP) - Weight of Evidence Analysis -

Glyphosate

No convincing evidence of potential interaction

with the estrogen, androgen or thyroid pathwaysJun 2015

Canada Pest Management Regulatory Agency (PMRA) Glyphosate is unlikely to pose a human cancer risk Apr 2015

Recent Glyphosate Regulatory Reviews

12

12

“Once-In-A-Century Herbicide”Duke and Powles, Pest Manag Sci 64:319-325 (2008)

Glyphosate’s versatility, effectiveness and safety have transformed

vegetation control across a wide range of environments worldwide

13

Experts to Review and Address EPA’s Charge Questions

Name Affiliation Title Topic

Donna Farmer, Ph.D.Monsanto

CompanySenior Toxicologist Opening Remarks

Caroline Harris, Ph.D. ExponentCorporate Vice President, Center

Director and Principal ScientistDietary Exposure

John Acquavella, Ph.D.,

FACE, FISPE

Aarhaus

University

Professor, Department of Clinical

EpidemiologyEpidemiology (Q2)

James Bus, Ph.D., DABT,

ATSExponent Senior Managing Scientist Animal Bioassay (Q3)

Joseph Haseman, Ph.D.J.K. Haseman

ConsultingPresident Biostatistics

David Kirkland, Ph.D.Kirkland

Consulting

Genetic Toxicology ConsultantGenotoxicity (Q4)

Rick Reiss, Sc.D. ExponentGroup Vice President and

Principal Scientist

Carcinogenicity

Classification (Q5) &

Closing Remarks