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Regulatory status of
GLYPHOSATE

Richard Garnett
23 March 2010
Monsanto Company
Some history
Q: When was the first European registration of a glyphosate product?

A: 1974. The first sales of Roundup were in the UK for perennial weed
   control in autumn stubbles
Three consequences of that long history which affect regulatory status:
1. Over 2-3 generations of users, the major impact of the ability to control perennial
   weeds has been forgotten. Glyphosate is now a “tool” - benefits are underestimated
2. The considerable data generated on efficacy & benefits, and the years of successful
   use, are sometimes forgotten by regulators when they need to “tick boxes”
3. Glyphosate is one of the most researched pesticides or chemicals – efficacy, crop
   safety, fate, toxicity, environmental impact. It is targetted by “campaigning scientists”
Major regulatory reviews
• EU review completed 2001
   – All uses reviewed and considered “acceptable” for all exposures
   – Including on glyphosate tolerant crops (beet, maize, cotton)
• FAO/WHO JMPR (Joint Meeting on Pesticide Residues)
   – 2004 toxicology, 2005 residues
   – Short & long term dietary intake unlikely to present a public health
     concern
• WHO Environmental Health Criteria 159
   –   and WHO water criteria (5000 µg/L)
• Other major OECD countries including Japan, USA, Canada, Brazil,
  Australia
   – Many countries will review in the near future
Some broad challenges
• Addressing monitoring & findings in surface water
    – Below threshold of ecotoxicological risk (Environmental Quality Standard)
    – Removed by chlorination and ozonation for drinking water
    – Demonstrate reduced levels (Water Framework Directive)
• Address allegations of findings in ground water
    – Typically direct link to surface water or not a real finding
• Demonstration of practical weed resistance risk mitigation plans,
  effective monitoring and resistance management plans
• Questions not covered by standard regulatory requirements
    – Allegations derived from in vitro studies e.g. Seralini, Belle, Walsh
    – Claims from epidemiology studies e.g. US AgHealth study
    – Alleged impact on micro nutrient uptake e.g. Roemheld, Huber
• Studies are being undertaken to address these
Regulatory status in the EU
• Inclusion in Annex I of Directive 91/414/EC in November 2001
   – Thorough evaluation by Germany as rapporteur Member State
   – Peer reviewed by all Member States (MS)
   – Stakeholder inputs
   – No significant restrictions
       • maximum annual dose 4.32 kg a.s./ha

• Re-registration of all products by Member States (MS) by July 2006
   – Thorough evaluation now completed in most MS
   – Maintained broad range of uses
Registration of Roundup Ready herbicide
• Evaluated in Annex I inclusion process
• Roundup Ready herbicide is approved in RR crops:
   – Germany (beet 2003, maize 2006)
   – Czech Republic (beet 2003, maize 2007)
   – Slovakia (maize 2009)
   – Romania (soyabean)
   – Spain (maize: evaluation completed awaiting maize approval)
• Dossiers submitted in other major maize growing countries
• Covers events containing CP4
   – Alone and in stacks
Renewal of Annex I inclusion
• Under current legislation, inclusion expires June 2012
• Draft AIR2 Regulation (Annex I Renewal, 2nd list of active
  substances)
   – Includes glyphosate (and its salts)
   – Extension to end 2013?
• Glyphosate Task Force set up to submit a single notification
   – Interested companies are working together
   – New studies and risk assessments to meet latest requirements
   – Output = joint dossier
Regulatory timelines and process
            Schedule under draft AIR2 regulation

                                  Current expiry



                                     June 2012

    Nov 2010                   March 2012          Dec 2013


Formal notification?         Submit dossier?       Extension?
Looking ahead
• Active stewardship
  – Promotion of Risk mitigation
  – Demonstrate Risk management
• New legislation
  – Sustainable Use Directive
  – Water Framework Directive
  – New Pesticide Authorisation Regulation
• Common Agriculture Policy
Thank you




for your keen attention

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R Garnett

  • 1. Regulatory status of GLYPHOSATE Richard Garnett 23 March 2010 Monsanto Company
  • 2. Some history Q: When was the first European registration of a glyphosate product? A: 1974. The first sales of Roundup were in the UK for perennial weed control in autumn stubbles Three consequences of that long history which affect regulatory status: 1. Over 2-3 generations of users, the major impact of the ability to control perennial weeds has been forgotten. Glyphosate is now a “tool” - benefits are underestimated 2. The considerable data generated on efficacy & benefits, and the years of successful use, are sometimes forgotten by regulators when they need to “tick boxes” 3. Glyphosate is one of the most researched pesticides or chemicals – efficacy, crop safety, fate, toxicity, environmental impact. It is targetted by “campaigning scientists”
  • 3. Major regulatory reviews • EU review completed 2001 – All uses reviewed and considered “acceptable” for all exposures – Including on glyphosate tolerant crops (beet, maize, cotton) • FAO/WHO JMPR (Joint Meeting on Pesticide Residues) – 2004 toxicology, 2005 residues – Short & long term dietary intake unlikely to present a public health concern • WHO Environmental Health Criteria 159 – and WHO water criteria (5000 µg/L) • Other major OECD countries including Japan, USA, Canada, Brazil, Australia – Many countries will review in the near future
  • 4. Some broad challenges • Addressing monitoring & findings in surface water – Below threshold of ecotoxicological risk (Environmental Quality Standard) – Removed by chlorination and ozonation for drinking water – Demonstrate reduced levels (Water Framework Directive) • Address allegations of findings in ground water – Typically direct link to surface water or not a real finding • Demonstration of practical weed resistance risk mitigation plans, effective monitoring and resistance management plans • Questions not covered by standard regulatory requirements – Allegations derived from in vitro studies e.g. Seralini, Belle, Walsh – Claims from epidemiology studies e.g. US AgHealth study – Alleged impact on micro nutrient uptake e.g. Roemheld, Huber • Studies are being undertaken to address these
  • 5. Regulatory status in the EU • Inclusion in Annex I of Directive 91/414/EC in November 2001 – Thorough evaluation by Germany as rapporteur Member State – Peer reviewed by all Member States (MS) – Stakeholder inputs – No significant restrictions • maximum annual dose 4.32 kg a.s./ha • Re-registration of all products by Member States (MS) by July 2006 – Thorough evaluation now completed in most MS – Maintained broad range of uses
  • 6. Registration of Roundup Ready herbicide • Evaluated in Annex I inclusion process • Roundup Ready herbicide is approved in RR crops: – Germany (beet 2003, maize 2006) – Czech Republic (beet 2003, maize 2007) – Slovakia (maize 2009) – Romania (soyabean) – Spain (maize: evaluation completed awaiting maize approval) • Dossiers submitted in other major maize growing countries • Covers events containing CP4 – Alone and in stacks
  • 7. Renewal of Annex I inclusion • Under current legislation, inclusion expires June 2012 • Draft AIR2 Regulation (Annex I Renewal, 2nd list of active substances) – Includes glyphosate (and its salts) – Extension to end 2013? • Glyphosate Task Force set up to submit a single notification – Interested companies are working together – New studies and risk assessments to meet latest requirements – Output = joint dossier
  • 8. Regulatory timelines and process Schedule under draft AIR2 regulation Current expiry June 2012 Nov 2010 March 2012 Dec 2013 Formal notification? Submit dossier? Extension?
  • 9. Looking ahead • Active stewardship – Promotion of Risk mitigation – Demonstrate Risk management • New legislation – Sustainable Use Directive – Water Framework Directive – New Pesticide Authorisation Regulation • Common Agriculture Policy
  • 10. Thank you for your keen attention