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Innovation and U.S. Regulation of the Products of Agricultural Biotechnology - Sally McCammon

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Innovation and U.S. Regulation of the Products of Agricultural Biotechnology - Sally McCammon

  1. 1. OECD Conference on Genome Editing: Applications in Agriculture—Implications for Health, Environment and Regulation Session 3: Regulatory aspects Innovation and U.S. Regulation of the Products of Agricultural Biotechnology June 30, 2018 Sally L. McCammon, U.S. Department of Agriculture Kathleen M. Jones, U.S. Food and Drug Administration Mike Mendelsohn, U.S. Environmental Protection Agency
  2. 2.  Modernizing the Coordinated Framework  Report of the Task Force on Rural Prosperity  USDA- U.S. Department of Agriculture  FDA-U.S. Food and Drug Administration  EPA-U.S. Environmental Protection Agency Presentation Outline
  3. 3. U.S. Coordinated Framework for Regulation of Biotechnology Products • Describes federal regulatory system for evaluating products of biotechnology • Based on existing laws that provide basic network of agency jurisdiction • Established formal policy in 1986; updated in 1992 and 2017 3
  4. 4. Ongoing effort initiated in 2015 Goal: Ensure public confidence in regulatory system and improve transparency, predictability, coordination, and efficiency of the regulatory system Two key documents: 1. 2017 Update to the Coordinated Framework - Published in January 2017 - Clarifies roles and responsibilities of agencies that regulate biotechnology products 2. National Strategy for Modernizing the Regulatory System for Biotechnology Products - Published in September 2016 - Identifies agency activities to ensures the regulatory system is well- prepared for the future products of biotechnology “Modernizing the Regulatory System for Biotechnology Products” 4
  5. 5.  USDA-Animal and Plant Health Inspection Service (APHIS)  Protection of Plant Health  Safety of Veterinary Biologics  U.S. Environmental Protection Agency (EPA)  Regulation of Plant Incorporated Protectants (PIPs) as bio-pesticides  Safe Use of New Pesticides  Safe Use of Chemicals  U.S. Food and Drug Administration (FDA)  Safety of Food, Food Additives and Feed  Safety of Veterinary and Human Drugs, and Human Biologics Agency Responsibility
  6. 6.  National Strategy for Modernizing the Regulatory System for Biotechnology Products – September 2016.  https://obamawhitehouse.archives.gov/sites/default/files/microsite s/ostp/biotech_national_strategy_final.pdf  2017 Update of the Coordinated Framework – January 2017.  https://www.epa.gov/sites/production/files/2017- 01/documents/2017_coordinated_framework_update.pdf  Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System – National Academy of Sciences – March 2017  http://nas-sites.org/biotech/ Coordinated Framework Documents
  7. 7. Authoritative Scientific Reports 2017 2017 2016 77
  8. 8. TASK FORCE ON AGRICULTURE AND RURAL PROSPERITY Purpose and function: To identify legislative, regulatory, and policy changes to promote agriculture, economic development, job growth, infrastructure improvements, technological innovation, energy security, and quality of life in rural America. -October, 2017
  9. 9. TASK FORCE ON AGRICULTURE AND RURAL PROSPERITY Call to Action: • e-Connectivity for Rural America • Supporting a Rural Workforce • Improving Quality of Life • Harnessing Technological Innovation • Economic Development
  10. 10. TASK FORCE ON AGRICULTURE AND RURAL PROSPERITY Call to Action #4: Harnessing Technological Innovation • Stream-lined, science-based Regulatory Policy for Biotechnology – Coordinate Federal regulation of biotech products – Coordinate Interagency action through the Office of Science and Technology Policy • Small and mid-sized innovators • Protect consumers – Expedite Commercialization of Biotech Products
  11. 11. Current USDA-APHIS biotech regulation Plant Protection Act (2000)  Regulates movement* of regulated articles o Importation o Interstate movement o Environmental Release (confined) *Permit or Notification is required Organism (living) 1. Genetically engineered and 2. Plant pest involved (donor, recipient, vector)
  12. 12. * 2017 data collected through September 2017. 0 50 100 150 200 250 300 350 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 Cumulative Number of APHIS-Authorized Permits/Notifications CRISPR TALEN ZFN *
  13. 13. “Am I Regulated” (AIR) Process • Am I Regulated by USDA/APHIS? • Developers submit “Letter of Inquiry” to APHIS 64 Letters and responses (July, 2011- May 18, 2018) http://www.aphis.usda.gov/biotechn ology/am_i_reg.shtml
  14. 14. Case-by-Case Genetic Modification –Deletion –Substitution –Insertion *FDA, EPA, APHIS-PPQ Plant Pest Component –Donor –Vector • Agrobacterium –Vector Agent •TALENS
  15. 15. Genome Editing “Am I Regulated” Requests Site Directed Nuclease Number of Inquires Number Pending Number of Responses * Meganuclease 4 0 4 Zinc Finger 1 0 1 TALEN 9 0 9 CRISPR 10 2 8 TOTAL 24 2 22 * All are SDN-1, All Responses = Not Regulated
  16. 16. Plants • Ornamental plants • Baby’s breath • Tobacco • Corn • Apple • Grapevine • Pineapple • Plum • Potato • Soybean • Arabidopsis • Loblolly pine • Grasses – Kentucky Blue Grass – Switchgrass – St. Augustine Grass – Tall Fescue – Bahia Grass – Setaria • Wheat • Rice • Sorghum • Camelina • Moss
  17. 17. USDA Need for Change Bring regulation into alignment with the U.S. Coordinated Framework for the Regulation of Biotechnology – Prepare U.S. regulation for products of emerging technologies of tomorrow – Focus on GE organisms that pose a risk to Plant Health – Regulatory Relief – Regulatory Experience
  18. 18. Secretary Perdue Issues USDA Statement on Plant Breeding Innovation Washington, D.C., March 28, 2018 Clarification of USDA’s oversight of plants produced through innovative new breeding techniques, including techniques called genome editing.
  19. 19. • Does not change the existing USDA-APHIS biotech regulation (7 CFR Part 340). • Many genome edited plants do not meet the regulation criteria to be subject to this regulation. • Maintain a science-based approach to plant breeding innovation USDA Statement on Plant Breeding Innovation (continued) Secretary Perdue Statement on Plant Breeding Innovation
  20. 20. Approach to Plant Breeding Innovation: Avoid additional regulation of plants indistinguishable to those developed by traditional techniques or Organisms that are created using techniques that could otherwise have been produced using: - Traditional breeding techniques - Chemical-based mutagenesis - Radiation based mutagenesis
  21. 21. What does this mean in practice? Organisms with the following alterations would not be considered regulated under the USDA proposed approach: – Deletions – Single base-pair substitution – Introduction of sequences from sexually compatible plant relatives – Complete null segregants
  22. 22. Why issue the clarification statement now? Clarity about regulatory treatment of plant breeding innovations is important: ...to help promote international regulatory compatibility, which is important to minimize trade disruption …and other countries are already forming policies on plant breeding innovations such as genome editing …and engage with stakeholders
  23. 23. Thank you!RS http://www.aphis.usda.gov/biotechnology/index.shtml

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