UNDER ATTACK PARTNERED WITH UNDER ATTACK 30 000

UNDER ATTACK PARTNERED WITH:

UNDER ATTACK • 30. 000 species of Weeds • 10. 000 species of Insects • 3. 000 species of Nematodes • Bacteria, Water molds, Fungi, Viruses

UNDER ATTACK • Plant pests & diseases account for est. 30%-40% of global crop production losses UNDER ATTACK • FAO: $85 billion caused by pathogens • FAO: $46 billion caused by insects • Insect pests affect > 85 million ha of forests WW.

UNDER ATTACK • PLANT BREEDING has provided • • RESISTANCE BREEDING • UNDER ATTACK => 10. 000 s of resistant varieties => major breeding goal

CROP PROTECTION Interviewed 9 people from 6 companies & organizations Part 1: History & recent changes Part 2: Challenges in CPP development Part 3: Future Trends and Outlook UNDER ATTACK

CROP PROTECTION – PART 1 Interviewed 9 people from 6 companies & organizations Part 1: History & recent changes Part 2: Challenges in CPP development Part 3: Future Trends and Outlook UNDER ATTACK

CPP - 1 : HISTORY & RECENT CHANGES • Earliest records: 4500 yrs ago • Tried: rotation, removing morning dew, tillage, magic, prayer, virtuous life, rituals etc => reliance on CPP • Application rates & toxicity levels down • Development costs up (>200 mio€/230 mio$, of which >70 mio€/80 mio$ is on toxicology => safety) UNDER ATTACK

HISTORY SEED TREATMENT - 1 • 4000 yrs ago: Oldest known proof of seed treatment • 2000 BC: Onion or cypress sap used on seeds in Egypt, Greece and parts of the Roman Empire • mid-1600 s: Salt water treatments UNDER ATTACK

HISTORY SEED TREATMENT - 2 • mid 1700 s: First copper products were introduced. • 1740 – 1808: Introduction & use of arsenic • 1915 - 1982: Introduction & use of mercury UNDER ATTACK

HISTORY SEED TREATMENT - 3 • Until the 1960 s seed treatments were only surface disinfectants and protectants. • 1968: First systemic fungicide product launched UNDER ATTACK

CROP PROTECTION – PART 2 Interviewed 9 people from 6 companies & organizations Part 1: History & recent changes Part 2: Challenges in CPP development Part 3: Future Trends and Outlook UNDER ATTACK

CPP - 2: CHALLENGES IN CPP DEVELOPMENT • 11 yrs research & >200 mio € (> 230 mio$) • Very low amount A. I. approved (<5) • Unpredictable regulation WW • Public scrutiny by activist campaigns • Biologicals: on-seed survival • Understanding future needs UNDER ATTACK

CROP PROTECTION – PART 2 Interviewed 9 people from 6 companies & organizations Part 1: History & recent changes Part 2: Challenges in CPP development Part 3: Future Trends and Outlook UNDER ATTACK

CPP - 3: FUTURE TRENDS AND OUTLOOK • Biologicals & RNA(i)/DNA • Digital & Technological advances • =>more precise diagnosis • Improved nutritional support • Patent expiration => generics • Public trust UNDER ATTACK

UNDER ATTACK

CPP CONCLUSIONS • 40% of potential harvest = lost to damaging pests • New tech with improved profiles (biologically & environmentally) • Integrated approach / prevent resistance • Adequate reliable food supply cannot be guaranteed without CPP • Science, not politics to drive decision making UNDER ATTACK

NEONICS IN EU • 2013: restrictions on Clothianidin, imidacloprid, thiamethoxam & fipronil • Court cases by Bayer, Syngenta & BASF • 17 May 2018: EU General Court confirmed restrictions and did not object to non-official use of Bee-Guidance document UNDER ATTACK

NEONICS – A WORLD WITHOUT INTRODUCTION TO PLANT BREEDING

NEONICS EC FAILED: • To properly apply Art. 21 on renewal of approval • To prove that neonics & fipronil caused unacceptable risks for honeybees at colony level EFSA • EFSA did not consider all available scientific data • EFSA based its RA on lab data, not on monitoring studies • Data gaps identified but ignored UNDER ATTACK

BEE GUIDANCE DOCUMENT • 2013: published by EFSA • (RA on honeybees, bumblebees and solitary bees) • Dec. 2013: EC, EFSA & MS: • =>Revision necessary: No result • Not approved by EU member States UNDER ATTACK

BEE GUIDANCE DOCUMENT INDUSTRY: Significant revision necessary. PROBLEM: document not adopted & in need of revision, but used & influencing policy proposals

BEE GUIDANCE DOC – MAJOR CHALLENGES • Based on extremely conservative assumptions • Linked to unrealistic protection goals • Tiered risk assessment: trigger values too conservative • Requirements for higher tier testing studies not workable • Internationally validated test guidelines/methodologies not yet available. • Not enough testing capacity available in EU UNDER ATTACK

EU ON THE SIDELINES • Political pressure • Public hostility Strong barrier to invest in R&D for new PPPs NEAR FUTURE: • Less profitable or loss making PPPs withdrawn • No new AS’s forthcoming • EU left with only old PPPs • Trend already evident =>several herbicides & insecticides from 60 ies & 70 ies still marketed Source: N. Punja, “The impact of Regulation (EC) No 1107/2009 on innovation and development of alternatives and new plant protection products, Sept. 2018 – European Parliament UNDER ATTACK

RECOMMENDATIONS - 1 1. Raise Tier 1 threshold 2. Harmonize data requirements globally 3. Focus on ‘risk’, not on ‘hazard’ 4. Regulatory judgement based on good, peer-reviewed science UNDER ATTACK

RECOMMENDATIONS - 2 5. Allocate funds for training regulatory staff 6. Hire expert consultants to assist in evaluation of submitted dossiers 7. Organize liaison (regulators, academic, industry) when setting new guidelines 8. Re-instate provisional authorization UNDER ATTACK

THANK YOU FOR YOUR ATTENTION – QUESTIONS? UNDER ATTACK