SecondInternationalWorkshopforRegulationofAnimalBiotechnology:

PreparingMarketsforNewAnimalProductOpportunities

(August18‐21,2014‐Brasilia,Brazil)

Day 1: Monday, August 18, 2014

8:30Registration

9:00 Opening Remarks and Welcome

SESSION 1: Introduction to Animal Biotechnologies(moderator: Luiz Sergio Camargo, Brazil)

9:30 – 10:15Needs and Opportunities for Animal Biotechnology(JimMurray,US)

10:15 – 10:45Coffee Break

10:45 – 1:15Status 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;MarkTizard,Australia;JimMurray,US)
  • Dialog/questions

1:00 - 2:15Lunchand Posters

SESSION 2: Harmonization of RegulatoryApproaches(moderator: Diane Wray-Cahen, US)

2:15 – 2:45Need for Harmonization - Lessons learned from the regulation of plant biotechnologies (Marcus Coelho, Brazil)

2:45 – 3:15Policy and Trade: Innovation, Regulation and Economic Performance ‐The Impact of Asynchronicity on the Chain (Alejandro Silva, Argentina)

3:15 – 3:45Coffee Break

3:45 – 5:00Panel: 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 – 6:00Industry 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 – 10:15Animal 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 – 10:45Coffee Break

SESSION 4: Technology and Science-directed Regulation(moderator: Luciana Bertolini, Brazil)

10:45 – 12:45Panel: Science-based regulations and challenges associated with animal biotechnologies

  • Using science to informrisk 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 – 2:00Lunch 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 – 3:25Panel: 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 – 3:55Coffee Break

3:55 – 5:00Panel: 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 (co-facilitators: 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 – 9:30Engaging and Persuasive Science Communication (Tamar Haspel, Journalist, US)

9:30 – 10:00Role of Trust in Advancing Animal Biotechnology (Guillherme Trivellato, Oxitec, Brazil)

10:00 – 11:00Addressing Concerns and Issues through Communication (Mahaletchumy Arujanan, Malaysian Biotechnology Information Center, Malaysia)

11:00 – 11:30Coffee Break

11:30 – 12:30Panel: Approaches to ImproveCommunication 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: LucBourbonnière)

2:00 – 2:30Regulatory Coordination: Domestic and International Challenges (Larisa Rudenko, FDA, US)

2:30 –5:30CONCURRENT 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 – 6:00Report out on Breakout Dialogs - Sessions 6 and 8

7:00Workshop 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 – 9:30Regulation in a Rapidly Evolving Environment: Balancing Risk and Innovation (Jennifer Kuzma, North Carolina State University, US)

9:30 – 11:15Dialog 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 – 11:45Coffee Break

11:45 – 12:30Break-out session report out

12:30 – 1:00Closing Speaker(Mark Walton, Recombinetics, US)

1:00 Workshop Ends