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  • 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