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CORESTA Developments and Activities Dr Stphane Colard, Secretary General (Designate) Mr Lea Scott, President Scientific Commission (Universal Leaf) Dr Rob Stevens, Vice President Scientific Commission (ITG Brands) October 2 nd , 2019, FDA

  1. CORESTA Developments and Activities Dr Stéphane Colard, Secretary General (Designate) Mr Lea Scott, President Scientific Commission (Universal Leaf) Dr Rob Stevens, Vice President Scientific Commission (ITG Brands) October 2 nd , 2019, FDA Center for Tobacco Products

  2. Outline ❖ Introduction to CORESTA ❖ Key activities in the Study Groups ❖ The strengths of CORESTA COR-236-CXP FDA/CTP www.coresta.org 2 2 Oct, 20191002

  3. CORESTA Cooperation Centre for Scientific Research Relative to Tobacco A non-pro rofit o organisation cre reated i in 1956 governed b by Fre rench law Purpose* To promote cooperation in scientific research relative to tobacco and its derived products *Legally binding COR-236-CXP FDA/CTP www.coresta.org 3 2 Oct, 20191002

  4. The Vi Vision “ To be recognised by our members and relevant external bodies as an authoritative source of publicly available credible science and best practices ” related to tobacco and its derived products COR-236-CXP FDA/CTP www.coresta.org 4 2 Oct, 20191002

  5. Membership 162 members (September 2019) >600 participants across 26 Sub-Groups and Task Forces COR-236-CXP FDA/CTP www.coresta.org 5 2 Oct, 20191002

  6. Strategy and Policy: Governance & Structure re 14 elected/co-opted organisations Workshops & Administration General 3.5 people Annual Conferences Board Secretariat Agronomy & Leaf Integrity 26 subject or Phytopathology & product-specific Genetics Working Groups (Sub-Groups or Product Scientific Task Forces) Technology General Commission Smoke ~ 600 experts Assembly Science Technical Oversight: Agrochemical 162 Member 20 elected experts Advisory Committee organisations COR-236-CXP FDA/CTP www.coresta.org 6 6 2 Oct, 20191002

  7. Spectrum of Scientific Cooperation Topics • Integrated Pest Management • Routine Analytical Chemistry • Virus Diseases • Physical Test Methods • Extended Diagnostic Expert System • Cigar Smoking Methods • Efficacy of Biological & Eco-Friendly Crop Protection Agents • Tobacco and Tobacco Products Analytes • Collaborative Study Black Shank • E-Vapour • Tobacco Alkaloid Genetics • Cigarette Variability • Tobacco Biotechnology and Omics • Heated Tobacco Products • Agrochemicals Analysis • Pest and Sanitation Management in • Product Use Behaviour Stored Tobacco 26 26 • Smoke Analytes • Proficiency Testing for Detection of • In Vitro Toxicity Testing Transgenic Tobacco • Biomarkers Current • TSNA in Air-cured and Fire-cured Tobacco • Consumer Reported Outcome • Agrochemical Residue Field Trials Working Measures Consortium • Collaborative Study of Low Nicotine • 21st Century Toxicology for Groups Tobacco Agronomic Production Next Generation Tobacco and Practices Nicotine Products COR-236-CXP FDA/CTP www.coresta.org 7 2 Oct, 20191002

  8. The Pro rocess (Simplified) CORESTA Members Working Groups Scientific Commission Board General Secretariat COR-236-CXP FDA/CTP www.coresta.org 8 8 2 Oct, 20191002

  9. Publications Abstracts & Technical Presentations Reports ~ 9000 abstracts/presentations www.coresta.org Methods Guides COR-236-CXP FDA/CTP www.coresta.org 9 9 2 Oct, 20191002

  10. Agro ronomy & Leaf Integrity Phytopathology & Genetics Lea SCOTT President of the Scientific Commission

  11. Agr gronomy and Phytopathology Agronomy and Leaf Integrity ❖ Scientific study on the production of all tobacco leaf types ❖ Crop management practices and environmental factors that influence crop production ❖ Good Agricultural Practices for efficient, sustainable tobacco production and leaf supply ❖ Guidance on pest & sanitation of stored tobaccos Phytopathology and Genetics ❖ Study of tobacco pests and diseases and plant breeding ❖ Integrated Pest Management (IPM) ❖ Genetic mapping, molecular markers and genetic diversity COR-236-CXP FDA/CTP www.coresta.org 11 2 Oct, 20191002

  12. Agr gronomy and Phytopathology Current activities ❖ Proficiency testing of multi-residue analytical methods for agrochemical residues and for detection of transgenic tobacco ❖ Agrochemical residue field trials to support setting/review of Guidance Residue Levels ❖ Investigation of low nicotine tobacco agronomic practices ❖ Regular Infestation Control Conferences ❖ Identification and evaluations of biological control products and methods ❖ Sharing of tobacco genetic materials for disease resistance ❖ Defining biotechnology terminology for non-scientists ❖ Data contribution to Di@gnoplant COR-236-CXP FDA/CTP www.coresta.org 12 2 Oct, 20191002

  13. Agr grochemical A Advisory Committee ❖ Objectives ➢ To address matters relating to agrochemicals* and topics associated with product stewardship and integrity in tobacco by gathering relevant information and disseminating guidance to stakeholders. ❖ Guidance documents ➢ No. 1 - Agrochemical Guidance Residue Levels (GRLs) ➢ No. 3 - Good Agricultural Practices (GAP) Guidelines ➢ No. 19 - Responsible Use of Crop Protection Agents (CPAs) in Tobacco Leaf Production ➢ No. 21 - Best Practices and Crop Protection in Cigar Dark Air-Cured Tobacco ➢ No. xx - Technical Aspects of CPA Usage (underway) * Agrochemicals are those substances used in farming to manage pests or to regulate plant growth. They are also referred to as crop protection agents (CPAs) and plant protection products (PPPs), including biopesticides. COR-236-CXP FDA/CTP www.coresta.org 13 2 Oct, 20191002

  14. Smoke Science Pro roduct Technology Rob STEVENS Vice-President of the Scientific Commission

  15. Smoke S Science a and Product T Technology Smoke Science ❖ Responsible for the scientific study of emissions from, and exposure to, tobacco and related products. ❖ Development of specific chemical and biological methods and investigation of means to assess exposure and use. Product Technology ❖ Concerned with the study of processes and procedures relating to tobacco processing and manufacturing facilities. ❖ Description of tobacco and tobacco products in terms of physical properties, chemical properties and quality. ❖ Development of Reference Materials. COR-236-CXP FDA/CTP www.coresta.org 15 2 Oct, 20191002

  16. Smoke S Science a and Product T Technology ❖ Recommended Methods*, Guides and Reports on tobacco, product and smoke analysis (biological, chemical and physical) ⚫ Since 1956, 93 CORESTA Recommended Methods (CRMs) produced, of which 43 ISO standards based on CRMs ⚫ + 3 CRMs currently in the process of becoming ISO standards ⚫ Regular collaborative studies/proficiency trials to support member labs’ accreditation (agrochemicals, TNCO, physical…) ⚫ Protocols for in vitro toxicity testing of mainstream smoke ❖ Developed Reference Materials ⚫ ‘ CORESTA Monitor test piece’ for smoking machine set -up + 1 for LIP testing ⚫ 4 smokeless tobacco products *71 out of 92 CRMs are currently active, due to obsolescence/replacement of older ones COR-236-CXP FDA/CTP www.coresta.org 16 2 Oct, 20191002

  17. Development o of Recommended Methods ➢ Consensus-based process Paper-based Preliminary Define assessment of Method practical available purpose optimisation assessment methods Collaborative study: draft CRM Publish Data evaluation CRM using ISO 5725 10-20 labs multiple products ➢ Discussions during process provide insight into causes/reduction of intra- and inter-laboratory variability ➢ Methods and Reports are made available on the CORESTA website COR-236-CXP FDA/CTP www.coresta.org 17 2 Oct, 20191002

  18. Smoke S Science a and Product T Technology Current activities ❖ Ongoing contribution to ISO TC126 standards development (CORESTA is a Liaison A member) ❖ Experimental evaluation of commercial cigarette variability over short term (one production week), medium term (production over one year), and long term (production over three years) ❖ Regular collaborative studies and proficiency tests ❖ E-cigarette and Heated Tobacco Product working groups ❖ Analytical methods for cigars ❖ Working groups on Consumer Reported Outcomes and 21 st Century Toxicology (NGPs) COR-236-CXP FDA/CTP www.coresta.org 18 2 Oct, 20191002

  19. The Stre rengths of CORESTA

  20. The stre rengths of CORESTA ❖ Transparent and inclusive ways of working ➢ global inter-disciplinary participation ➢ non-member expertise welcomed ➢ annual meetings open to all interested parties ❖ Focus on sharing and advancing scientific knowledge ❖ Proficiency testing activity supports laboratory accreditation ❖ Track record supporting development of International Standards COR-236-CXP FDA/CTP www.coresta.org 20 2 Oct, 20191002

  21. Thank you COR-236-CXP FDA/CTP www.coresta.org 21 2 Oct, 20191002

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