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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 wer...
Major regulatory reviews
• EU review completed 2001
   – All uses reviewed and considered “acceptable” for all exposures
 ...
Some broad challenges
• Addressing monitoring & findings in surface water
    – Below threshold of ecotoxicological risk (...
Regulatory status in the EU
• Inclusion in Annex I of Directive 91/414/EC in November 2001
   – Thorough evaluation by Ger...
Registration of Roundup Ready herbicide
• Evaluated in Annex I inclusion process
• Roundup Ready herbicide is approved in ...
Renewal of Annex I inclusion
• Under current legislation, inclusion expires June 2012
• Draft AIR2 Regulation (Annex I Ren...
Regulatory timelines and process
            Schedule under draft AIR2 regulation

                                  Curre...
Looking ahead
• Active stewardship
  – Promotion of Risk mitigation
  – Demonstrate Risk management
• New legislation
  – ...
Thank you




for your keen attention
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Transcript of "R Garnett"

  1. 1. Regulatory status of GLYPHOSATE Richard Garnett 23 March 2010 Monsanto Company
  2. 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. 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. 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. 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. 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. 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. 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. 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. 10. Thank you for your keen attention
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