Second International Workshop for Regulation of Animal Biotechnology: Preparing Markets for New Animal Product Opportunities (August 18‐ 21, 2014 ‐ Brasilia, Brazil) Day 1: Monday, August 18, 2014 8:30 Registration 9:00 Opening Remarks and Welcome SESSION 1: Introduction to Animal Biotechnologies (moderator: Luiz Sergio Camargo, Brazil) 9:30 – 10:15 Needs and Opportunities for Animal Biotechnology (Jim Murray, US) 10:15 – 10:45 Coffee Break 10:45 – 1:15 Status Reports - Science and Technology Advances in Animal Biotechnologies Livestock cloning (Flavio Meirelles, Brazil) Gene editing in food animals (Scott Fahrenkrug, US) Genetically engineered animals: reports from different countries (Chang Zhijie, China; Mark Tizard, Australia; Jim Murray, US) Dialog/questions 1:00 - 2:15 Lunch and Posters SESSION 2: Harmonization of Regulatory Approaches (moderator: Diane Wray-Cahen, US) 2:15 – 2:45 Need for Harmonization - Lessons learned from the regulation of plant biotechnologies (Marcus Coelho, Brazil) 2:45 – 3:15 Policy and Trade: Innovation, Regulation and Economic Performance ‐The Impact of Asynchronicity on the Chain (Alejandro Silva, Argentina) 3:15 – 3:45 Coffee Break 3:45 – 5:00 Panel: Challenges and Opportunities for Regulatory Harmonization in Animal Biotechnology (moderator: Joshua J Malago, Tanzania) Regulatory approaches in different countries (Eric Hallerman, Virginia Tech, US) International organizations and guidances (Luc Bourbonnière, Health Canada; Jim Louter, Environment Canada) Challenges & Opportunities for Harmonization (Luiz Antônio Barreto de Castro, SBBiotec, Brazil) 5:00 – 6:00 Industry Panel: Impact of Differential Regulatory Approaches and Asynchrony on the use of Livestock Cloning (moderator: Chuck Long; Panel: Claudio Bisioli, Cabaña Nuevo Milenium, Argentina; Marc Maserati, Jr., InVitro Brasil Clonagem Animal; David Thorbahn, Select Sires Inc., US) DAY 2: Tuesday, August 19, 2014 SESSION 3: Potential for Animal Biotechnologies in Different Sectors (moderator: Mark Tizard, Australia) 9:00 – 9:30 Potential impact of animal biotechnology on food and economic security in developing economies (Steve Kemp, ILRI, Kenya) 9:30 – 10:15 Animal Industry Perspectives on Animal Biotechnology (David Thorbahn, World Wide Sires, US; John Swart, US) Opportunities/Needs for biotechnology Barriers to adoption of new technologies Impact of regulations on industry adoption/utilization of new technologies 10:15 – 10:45 Coffee Break SESSION 4: Technology and Science-directed Regulation (moderator: Luciana Bertolini, Brazil) 10:45 – 12:45 Panel: Science-based regulations and challenges associated with animal biotechnologies Using science to inform risk assessment and regulation (Eric Hallerman, US) Building multi-disciplinary teams (Luc Bourbonnière, Health Canada) Process-based versus product-based regulation (Harlan Howard, FDA, US) Food animal versus public health applications ((Flavio Finardi, CTNBio, Brazil) Environmental release of animals developed via biotechnology (Jim Louter, Environment Canada) 12:45 – 2:00 Lunch with Speaker (industry-sponsored; moderator: Scott Fahrenkrug, US) – “What can we learn from 20 years of genomic research regarding the risk of modifying genomes” (Perry Hackett, US) SESSION 5: Case Studies: Regulatory experiences with GE animals and insects 2:00 – 3:25 Panel: GE mosquito (moderator: Brinda Dass, US; Panel: Camilla Beech, Oxitec, UK; Dr. Margareth de Lara Capurro-Guimarães, University of Sao Paulo; Letchumanan Ramatha, Dept. of Biosafety, Malaysia; Ivette Vargas, Committee on Livestock Biosecurity, Panama) Regulatory process; Communication with public; Lessons learned, thus far 3:25 – 3:55 Coffee Break 3:55 – 5:00 Panel: GE Salmon (moderator: Yanina Petracca, Argentina; Panel: Ron Stotish, AquaBounty, US; Ivette Vargas, Committee on Livestock Biosecurity, Panama; Jim Louter, Environment Canada) Challenges in the process; Environmental issues; Lessons Learned, thus far SESSION 6: CONCURRENT SESSIONS 5:00 – 6:00 (Breakout dialogs) Moving towards better harmonization: gaps and capacity-building needs (cofacilitators: Maria Lucia Zaidan Dagli, CTNBio, Brazil; Purity Nguhiu, Ministry of Agriculture, Livestock and Fisheries, Kenya ) Building coalitions within the animal biotechnology sector to affect change (facilitator: Mark Walton, Recombinetics, US) DAY 3: Wednesday, August 20, 2014 SESSION 7: Building Trust through Communication and Transparency (moderator: Jennifer Kumza) 9:00 – 9:30 Engaging and Persuasive Science Communication (Tamar Haspel, Journalist, US) 9:30 – 10:00 Role of Trust in Advancing Animal Biotechnology (Guillherme Trivellato, Oxitec, Brazil) 10:00 – 11:00 Addressing Concerns and Issues through Communication (Mahaletchumy Arujanan, Malaysian Biotechnology Information Center, Malaysia) 11:00 – 11:30 Coffee Break 11:30 – 12:30 Panel: Approaches to Improve Communication and Improve/Increase Acceptance of Animal Biotechnology (Guillherme Trivellato, Tamar Haspel, Mahaletchumy Arujanan) 12:30 – 2:00 Lunch SESSION 8: Working Towards Coordination and Harmonization (moderator: Luc Bourbonnière) 2:00 – 2:30 Regulatory Coordination: Domestic and International Challenges (Larisa Rudenko, FDA, US) 2:30 – 5:30 CONCURRENT SESSIONS (Breakout dialogs with Coffee Break at 3:30) Hypothetical Case Study for Risk Assessment (Yanina Petracca, Argentina) Industry and Policy Makers - Working Together to Set the Stage for Global Harmonization (Alejandro Silva, Argentina; Matt O’Mara, US) 5:30 – 6:00 Report out on Breakout Dialogs - Sessions 6 and 8 7:00 Workshop Dinner (Mangai) DAY 4: Thursday, August 21, 2014 SESSION 9: Science, Regulation and Policy - Working Together to Balance Innovation and Safety (moderator: Jim Murray) 9:00 – 9:30 Regulation in a Rapidly Evolving Environment: Balancing Risk and Innovation (Jennifer Kuzma, North Carolina State University, US) 9:30 – 11:15 Dialog on guidance gaps, capacity building needs and strategies (Breakout sessions): Food safety assessment (co-facilitators: Luiz Antônio Barreto de Castro and Harlan Howard; scribe - Martin Kiogora Mwirigi) Environmental biosafety assessment (co-facilitators: Judith Ivette Vargas and Jim Louter; scribe –Arlene Villalez) Handling of socioeconomic issues (co-facilitators: Mahaletchumy Arujanan and Tamar Haspel; scribe – Laura Geller) Opportunities for harmonization (co-facilitators: Eric Hallerman and Maria Lucia Zaidan Dagli; scribe – Demeteris Hale) 11:15 – 11:45 Coffee Break 11:45 – 12:30 Break-out session report out 12:30 – 1:00 Closing Speaker (Mark Walton, Recombinetics, US) 1:00 Workshop Ends