3rd International Workshop for Regulation of Animal Biotechnology
June 26-30, 2017 - Charlottesville, Virginia, USA
International Organizing Committee: Eric Hallerman (Virginia Tech, USA), Diane Wray-Cahen (USDA), Yanina Petracca (Argentine Ministry of Agroindustry), Hellen Mbaya Kajuju (Kenyan National Biosafety Authority), Bruce Whitelaw (Roslin Institute, UK), Mark Walton (Yorktown Technologies, USA), Bill Hallman (Rutgers University, USA), S.R. Rao (Indian Ministry of Science & Technology)
- Introduction and Welcome – Eric Hallerman - Virginia Tech, Diane Wray-Cahen, USDA-FAS
- Communication as a cross-cutting theme - Bill Hallman – Rutgers University
- Animal breeding systems: Structure of different animal breeding sectors and regions.
- Animal breeding systems: Dairy and beef – Jay Weiker, National Association of Animal Breeders, US
- Global pig breeding - Dan Kovich, National Pork Producers Council, US
- Animal breeding systems for small ruminants – David Notter, Virginia Tech
- Tropical livestock – Marcos Medina, Ministry of Agriculture and Livestock, Paraguay
- Poultry (broiler) breeding – Rachel Hawken, Cobb-Vantress
- Animal breeding systems: aquaculture – Eric Hallerman, Virginia Tech University
- Science and technological advances in animal biotechnologies
- Genomic selection – Alison Van Eenennaam, University of California-Davis, US
- Genetically engineered animals – Jim Murray, University of California –Davis, US
- Genome editing in agricultural animals: Opportunities and challenges – Bhanu Telugu, University of Maryland, US
- Gene drives – Keith Hayes, CSIRO, Australia
- My thoughts on science communication – Alison Van Eenennaam, University of California –Davis, US
- Potential for Animal Biotechnologies in Different Animal Industry and Production Sectors
- Era of rewriting the livestock genome – Bruce Whitelaw, Roslin Institute, UK
- Biotechnology opportunities and challenges in poultry production – Mark Tizard, CSIRO Health & Biosecurity, Australia
- Biotechnology for the advancement of aquaculture – Rick Peterson, Intrexon
- Insect biotechnology: Current uses and future developments – Max Scott, North Carolina State University, US
- Role of Biotechnology in Africa – Steve Kemp, ILRI
- Psychology of risk perception – Meghnaa Tallapragada, University of Pennsylvania, US
- Selected regulatory frameworks and updates:
- United States: Modernizing the U.S. regulatory system for biotechnology products – Ritu Nalubola, Food and Drug Administration (FDA); Animal biotechnology and FDA regulation – Laura Epstein, FDA
- Brazil: Regulatory systems for GMOs in Brazil – the CTNBio – Maria Dagli, University of Sao Paulo
- Canada: Canadian regulatory oversight of genetically engineered animals – Stephen Dugan, Health Canada
- India: Regulatory framework in India for risk assessment, public engagement and post release management – S.R. Rao and A.K. Rabat
- China: Biosafety administration in China - Chang Zhijie, Tsinghua University
- GMOs in New Zealand: Recent changes in the “not GMO” regulations – Tim Strabala, Environmental Protection Authority
- Argentina: Regulation of GM animals in Argentina – Yanina Petracca, Argentine Ministry of Agroindustry
- Australia: Regulation of GMOs in Australia - Review of the Gene Technology Regulations 2001 – Louisa Matthew, Office of the Gene Technology Regulator
- Livestock biotech in inclusive agricultural transformation – Donald Nkrumah, Bill and Melinda Gates Foundation
- Opportunities and Challenges; strategies for dissemination of GM animals
- Challenges and opportunities: strategies for dissemination of GM animals in Africa – Appolinaire Djikeng, Roslin Institute, UK
- Strategies for dissemination of GM animals in India – S.R. Rao, Indian Ministry of Science and Technology
- Opportunities and challenges of genome editing in livestock for Latin America – Luiz Sergio Camargo, EMBRAPA, Brazil
- Developing biosafety regulations in developing countries: Experiences from Africa – Margaret Karembu, ISAAA
- Concurrent Sessions
- A. Regional Regulatory Breakout groups: Focus on regional animal biotechnology oversight issues. (Africa, Latin America, Asia, US/Canada/NZ/Australia/EU)
- Potential topics of discussion and debate (regional topics developed by each group leader):
- Special features of animal biotechnology, which could benefit region
- Capacity and capability of countries in region to develop animal biotech products
- Challenges and prospects for developing biotech animals in region
- Training opportunities available for animal scientists/regulators
- Identifying capacity and challenges of developing new regulatory framework
- Creating regional public awareness and best communicate about biotechnology
- Barriers to trade and effects on uptake of biotechnology in region
- Potential follow-up activities that would be beneficial within region.
- Industry/Developers Breakout group: Developer Best Practices - Market Communication
- Livestock value chain perspectives
- Developer case Studies
- Glo-ing the distance in animal biotechnology – Alan Blake, Yorktown Technologies
- Theory of Change – Nick Manson, Change Through Partnership UK
- Best Practices Roundtable – Panelists and discussion leaders: Jamie Jonkers, National Milk Producers; Courtney Knupp, National Pork Producers Council; Jay
- Weiker, National Association of Animal Breeders; Alan Blake, Yorktown Technologies; Nick Manson, Change Through Partnership UK
- Potential topics of discussion and debate (regional topics developed by each group leader):
- A. Regional Regulatory Breakout groups: Focus on regional animal biotechnology oversight issues. (Africa, Latin America, Asia, US/Canada/NZ/Australia/EU)
- Biosafety communication experiences in Africa – Margaret Karembu, CGIAR, ISAAA
- Overview of risk assessment-management framework – Eric Hallerman, Virginia Tech
- GM food safety assessment and data transportability – Masami Takeuchi, UNFAO
- Codex Alimentarius supporting documents
- Principles for the Risk Analysis of Foods Derived from Modern Biotechnology
- Guideline for the Conduct of Food Safety Assessment of Food Derived from Recombinant-DNA Plants
- Guideline for the Conduct of Food Safety Assessment of Foods Produced using Recombinant-DNA Microorganisms
- Guideline for the Conduct of Food Safety Assessment of Food Derived from Recombinant-DNA Animals
- What might a risk assessment for a genetically modified food producing animal look like? – Kevin Greenlees, USFDA
- Environmental release of animals developed via biotechnology – Paulo Andrade, Federal University of Pernambuco, Brazil
- Risk assessment for theoretical gene drive – Keith Hayes, CSIRO, Australia
- Panel: GE fishes: Challenges in the process, environmental issues, food safety issues, lessons learned, prospects.
- AquaAdvantage salmon: A regulatory odyssey – Ron Stotish, AquaBounty
- GloFish – Alan Blake, Yorktown Technologies
- Regulators – (AquAdvantage salmon – Kevin Greenlees, USFDA; Panel on GE fish – Stephen Dugan, Health Canada; Marco Mastellari, Ministry of Agricultural Development, Panama)
- Panel: GE insects, including mosquitos, crop and animal pests, silkworms: Regulatory process, communication with public, lessons learned, prospects.
- Regulation of insect biotechnologies: an industry perspective – Brad Shurdut, Intrexon Corp.
- Approach to the introduction of GM silkworms to sericulture farms for recombinant silk production in Japan – Keiko Kadono-Okuda, National Agriculture and Food Research Organization, Japan
- Transgenic strains for genetic control of the New World screwworm in Panama – Max Scott, North Carolina State University, US
- Regulators (APHIS, Brazil)
- Regulatory Experiences with Genetically Engineered Insects – Alan Pearson, Biotechnology Regulatory Services, APHIS-USDA
- Public perceptions about releasing genetically engineered mosquitoes in the context of Zika virus– Bob Lull, University of Pennsylvania
- Concurrent Sessions
- A. For regulators: Hypothetical case study: Confined release of cattle resistant to Trypanosome brucei rhodesiense in Kenya – Yanina Petracca, Argentine Ministry of Agroindustry; Ruth Mbabane, Michigan State University
- B. For Industry and Researchers: Developer and Value-Chain Views of Regulatory Actions to Encourage Innovation in Livestock Genetics
- Seed Industry Position on Regulation of New Breeding Technologies
- What do developers and the value chain want from regulatory oversight?
- Roundtable – Panelists and discussion leaders: Adrianne Massey, BIO; Tad Sonstegard, Recombinetics; Dan Jenkins, Genus; Mark Tizard, CSIRO; Dan Kovich, NPPC; Tim Kurt, FFAR; EFFAB = European branch organization for cooperatives, private companies and national associations in breeding and preproduction – Jan Venneman, EFFAB
- A. For regulators: Hypothetical case study: Confined release of cattle resistant to Trypanosome brucei rhodesiense in Kenya – Yanina Petracca, Argentine Ministry of Agroindustry; Ruth Mbabane, Michigan State University
- Psychology of food risks – Cara Cuite, Rutgers University
- Panel: Production and welfare related traits: Challenges in the process, lessons learned, prospects
- Biotechnology options for ethics and welfare in poultry production – Mark Tizard, CSIRO Health and Biosecurity, Australia
- Animal welfare and production traits in the pipeline – Tad Sonstegard, Recombinetics
- Engineering welfare traits in livestock –Bhanu Telugu, University of Maryland
- Use of precision genetics to advance beneficial traits for aquaculture species – Rick Peterson, Intrexon Corp.
- Panel: Disease resistant traits: Challenges in the process, lessons learned, prospects.
- Gene editing as applied to prevention of porcine reproductive and respiratory syndrome – Kristin Whitworth, University of Missouri, USA
- The Advance of GMO cattle in China – Chang Zhiijie, Tsinghua University, China
- Virus resistant transgenic silkworm, the status of its regulatory field trials, and progress towards regulatory approval – V.V. Satyavathi, Centre for DNA Fingerprinting and Diagnostics, India
- The Cartagena Protocol on Biosafety: What is it and why does it matter to you? – Fan-Li Chou, FAS USDA
- Regulating animal biotech in Africa, and lessons from crop biotechnology – Bernie Jones, Science Technology and Innovation for Development, UK
- Creating an enabling environment for innovation – past experiences and plans forward from the plant biotechnologies perspective – Fan-Li Chou, USDA-FAS
- OECD and harmonization – Sally McCammon, USDA-APHIS
- Understanding the World Trade Organization (WTO) Agreement on Sanitary and Phytosanitary Measures – Andrew Stephens, USDA-FAS
- Ethics and ideology in biotechnology: A practical approach – Margaret Foster Riley, University of Virginia, USA
- Socioeconomic considerations in regulatory decision-making – Patricia Zambrano, International Food Policy Research Institute
- Addressing public concerns in a science-based regulatory system – Bill Hallman, Rutgers University
- Breakout sessions: Dialog on guidance gaps, needs and strategies
- Food safety assessment
- Environmental biosafety assessment
- Handling of socioeconomic issues
- Opportunities for increasing regulatory consistency among countries
- Regulatory approaches and flexibility to account for emerging technologies
- Principles of risk communication – Cara Cuite, Bill Hallman (Rutgers University), Robert Lull and Meghnaa Tallapragada (University of Pennsylvania)
- “Hands-on” communication activities – Cara Cuite, Bill Hallman (Rutgers University), Robert Lull and Meghnaa Tallapragada (University of Pennsylvania), with subject matter experts Eric Hallerman (Virginia Tech), Jayne Raper (New York University), Max Scott (North Carolina State University), and Mark Tizard (CSIRO)