Global Regulatory Impacts of the IARC Glyphosate Classification Dan Jenkins Monsanto

What is IARC? The International Agency for Research on Cancer is a branch of the World Health Organization. The objective of the IARC is to promote international collaboration in cancer research. IARC does a great deal of important and highly valuable work http://www.iarc.fr/

EPSPS is found in some protozoa as well as plants and bacteria, so “microbes” is a better term than bacteria. hence the patent on glyphosate to control malaria because it can be used to reduce the malarial plasmodia in the blood

IARC Classification has Substantially Increased Negative Social Perception Undue confusion Cannot “unring the bell”

IARC Classification Resulted in Immediate Confusion and Growing calls for Bans Colombia Ban illicit crops (not a labeled use) France Ecology Minister asked garden stores to stop selling herbicides containing glyphosate Japan residue determination delay (ADI) (want to wait for monograph) US EPA, German BfR, Canada PMRA, Australia, APVMA, others… China CCM proposal to ban and w/draw Germany state consumer protection ministers called on the German federal government to immediately ban all non-professional uses of glyphosate. CA Prop 65, OSHA, HHP, GM Crop approvals… Canada request for review of continued sale/use in Ontario 20 March 2015 IARC 2A classification July 2015 IARC monograph April May June Bermuda suspends imports Switzerland Supermarket stop sales there are positive/reactive statements from other regulators but a/ while somewhat reassuring they often await the Monograph b/ they have minimal impact in the media compared to the NGO statements etc. Many governments have defended against calls for bans by NGOs by defending the science and their process. Brazil public prosecutor requests ban of ANVISA and revoking of GMO crop approvals Argentina FESPROSA request for ban in row crops EU ISDE requested a ban of EU Parliament Germany Retail Giant REWE removes from shelves Korea RDA will request in-country exposure assessment for local operators RDA will not receive any new registration applications Production cap based on what was done in 2014 Dark Outline = Gov’t action

Undercut the Science of Existing National Pesticide Risk Assessment Processes Added lot of work to regulators workload

Negative Significance for Agricultural Trade If glyphosate based herbicides are restricted or banned, it could significantly disrupt global agricultural trade. A ban or restriction would go against the Maximum residue levels (MRLs) of glyphosate established by Codex Alimentarius, the international standard recognized by the WTO.

Threatens GM Contribution to Global Food Security IARC conclusion is being leveraged by critics of GM crops Food production capacity is faced with a growing number of challenges, including a world population expected to grow to nearly 9 billion by 2050 and falling ratio of arable land to population. Between 1996 and 2012, crop biotechnology was responsible for an additional 122 million tons of soybeans and 231 million tons of corn. The technology has also contributed an extra 18.2 million tons of cotton lint and 6.6 million tons of canola. If crop biotechnology had not been available to the (17.3 million) farmers using the technology in 2012, maintaining global production levels at the 2012 levels would have required additional plantings of 4.9 million ha of soybeans, 6.9 million ha of corn, 3.1 million ha of cotton and 0.2 million ha of canola. Report available to download at www.pgeconomics.co.uk

IARC Classification Resulted in Immediate Confusion and Growing calls for Bans Colombia Ban illicit crops (not a labeled use) France Ecology Minister asked garden stores to stop selling herbicides containing glyphosate Japan residue determination delay (ADI) (want to wait for monograph) US EPA, German BfR, Canada PMRA, Australia, APVMA, others… China CCM proposal to ban and w/draw Germany state consumer protection ministers called on the German federal government to immediately ban all non-professional uses of glyphosate. CA Prop 65, OSHA, HHP, GM Crop approvals… Canada request for review of continued sale/use in Ontario 20 March 2015 IARC 2A classification July 2015 IARC monograph April May June Bermuda suspends imports Switzerland Supermarket stop sales there are positive/reactive statements from other regulators but a/ while somewhat reassuring they often await the Monograph b/ they have minimal impact in the media compared to the NGO statements etc. Many governments have defended against calls for bans by NGOs by defending the science and their process. Brazil public prosecutor requests ban of ANVISA and revoking of GMO crop approvals Argentina FESPROSA request for ban in row crops EU ISDE requested a ban of EU Parliament Germany Retail Giant REWE removes from shelves Korea RDA will request in-country exposure assessment for local operators RDA will not receive any new registration applications Production cap based on what was done in 2014 Dark Outline = Gov’t action

Given High Likelihood of Negative Downstream Impacts IARC Must Communicate Responsibly Monographs and Q & A clarifying their meaning and process at the time of announcement http://www.iarc.fr/en/media-centre/iarcnews/pdf/Monographs-Q&A.pdf What is the difference between risk and hazard? What do classifications in Groups 2A and 2B mean? Should IARC distinguish substances that are highly regulated versus substances that are not?

THANK YOU

Back Up

GM Contributions to Food Security Between 1996 and 2012, crop biotechnology was responsible for an additional 122 million tonnes of soybeans and 231 million tonnes of corn. The technology has also contributed an extra 18.2 million tonnes of cotton lint and 6.6 million tonnes of canola; GM crops are allowing farmers to grow more without using additional land. If crop biotechnology had not been available to the (17.3 million) farmers using the technology in 2012, maintaining global production levels at the 2012 levels would have required additional plantings of 4.9 million ha of soybeans, 6.9 million ha of corn, 3.1 million ha of cotton and 0.2 million ha of canola. This total area requirement is equivalent to 9% of the arable land in the US, or 24% of the arable land in Brazil or 27% of the cereal area in the EU (28); Crop biotechnology helps farmers earn reasonable incomes for their work. The net economic benefit at the farm level in 2012 was $18.8 billion, equal to an average increase in income of $117/hectare. For the 17 year period (1996-2012), the global farm income gain has been $116.6 billion; The highest yield gains were obtained by farmers in developing countries, many of which are resource-poor and farm small plots of land; The total farm income gain of $116.6 billion was divided equally between farmers in developing and developed countries; Crop biotechnology continues to be a good investment for farmers around the world. The cost farmers paid for accessing crop biotechnology in 2012 ($5.6 billion (4)(5) payable to the seed supply chain) was equal to 23% of the total gains (a total of $24.4 billion inclusive of the $18.8 billion income gains). Globally, farmers received an average of $3.33 for each dollar invested in GM crop seeds; Footnotes (1) Report available to download at www.pgeconomics.co.uk. Also contents available as two papers (with open access), separately, covering economic and environmental impacts, in the peer review journal GM Crops at www.landesbioscience.com/journal/gmcrops. GM Crops 5:1, p 1-11 Jan-March 2014 (economic impact paper) and vol 5.2, 1-11, April-June 2014 forthcoming for environmental impact paper. (2) As measured by the Environmental Impact Quotient (EIQ) indicator (developed at Cornell University). (3) By facilitating the adoption of no tillage production systems this effectively shortens the time between planting and harvest of a crop. (4) The cost of the technology accrues to the seed supply chain including sellers of seed to farmers, seed multipliers, plant breeders, distributors and the GM technology providers. (5) A typical ‘equivalent’ cost of technology share for non GM forms of production (eg, for new seed or forms of crop protection) is 30%-40%

Monsanto isn’t the only one that manufacturers glyphosate Monsanto isn’t the only one that manufacturers glyphosate. There are numerous companies and formulators.

In 1974, Monsanto developed a new herbicide called Roundup® In 1974, Monsanto developed a new herbicide called Roundup®. The original Roundup® formulation and the Roundup brand herbicides that followed were developed to control a wide variety of weeds, grasses and broadleaf plants. The active ingredient in the herbicide is called glyphosate. A majority of Roundup brand herbicides contain three components – the active ingredient glyphosate, water and a soap-like surfactant blend. Over the years, various formulations of Roundup brand products and other glyphosate-based herbicides have been developed by Monsanto and other companies, and these formulations are used throughout the world by farmers, landowners and homeowners.