FULL AGENDA

AGENDA

Second International Workshop for Regulation of Animal Biotechnology: 

Preparing Markets for New Animal Product Opportunities

August 18-21, 2014 - Brasilia, Brazil

International Organizing Committee: Dr. Luciana Bertolin (UNIFOR, Brazil), Dr. Luiz Sergio Camargo (EMBRAPA, Brazil), Prof. Martín Lema (MAGyP, Argentina),  Prof. Jim Murray (University of California-Davis, USA), Dr. Jose Luiz Rodrigues (UFRGS, Brazil),  Dr. Mark Tigard (CSIRO, Australia), Dr. Mark Walton (Recombinetics, USA), Dr. Diane Wray-Cahen (USDA, USA)

Rationale:

Animals that have been produced using biotechnologies and are intended for commercial production are approaching the market.  As a result, international organizations and the national authorities of a number of countries are developing frameworks for the food and environmental safety assessment of products of animal biotechnology.  As animal biotechnologies mature and grow, we need to evaluate where we are today and plan for where we will need to be tomorrow. 

Building on the first international animal biotechnology regulatory workshop in Argentina (2011), this workshop reviewed the emerging elements of regulatory frameworks for the food and environmental safety assessment of products from animals produced using animal biotechnologies, including cloning, genetic engineering, and gene editing. It was intended primarily for a global exchange among professionals working for regulatory agencies, biosafety specialists and animal biotechnology and production experts.

Day 1: Monday, August 18, 2014 

Session 1: Introduction to Animal Biotechnologies

     Needs and Opportunities for Animal Biotechnology (Jim Murray, US)

      Status Reports - Science and Technology Advances in Animal Biotechnologies 

• • Livestock cloning (Flavio Meirelles, Brazil)

  • Gene editing in food animals (Scott Fahrenkrug, US)

  • Regulation of genetically modified animals in China (Chang Zhijie, China)

  • Precision genome engineering in the chicken (Mark Tizard, Australia)

  • Transgenic animals for agriculture (Jim Murray, US)

Session 2: Harmonization of Regulatory Approaches 

       Need for Harmonization - Lessons learned from the regulation of plant biotechnologies (Marcus Coelho, Brazil)

       Policy and Trade: Innovation, regulation, and economic performance - The impact of asynchronous regulation on international trade (Alejandro Silva, Argentina)

       Panel: Challenges and Opportunities for Regulatory Harmonization in Animal Biotechnology

• • Regulatory approaches in different countries (Eric Hallerman, US)  

  • International organizations: Implications for rDNA animals (Luc Bourbonniere, Jim Louter, Canada)

  • Challenges and opportunities for harmonization of regulatory animal biotechnology (Luiz Antonio Barreto de Castro, Brazil)

       Industry Panel: Impact of Differential Regulatory Approaches and Asynchrony on the use of Livestock Cloning

• • Regulatory harmonization and global trade (Claudo Bisioli, Argentina)

  • Differential impact of regulatory approaches and asynchrony of livestock cloning (Marc Masserati, Jr., Brazil) 

  • Cloning value in bovine and animal agriculture (David Thorbahn, US)

Day 2: Tuesday, August 19, 2014

Session 3: Potential for Animal Biotechnologies in Different Sectors

        Potential impact of animal biotechnology on food and economic security in developing economies (Steve Kemp, Kenya)

        Animal Industry Perspectives on Animal Biotechnology:

• • Biotechnology investment (David Thorbahn, US)

  • Genetically engineered models of disease (John Swart, US)

Session 4: Technology and Science-directed Regulation

         Panel: Science-based regulations and challenges associated with animal biotechnologies

• • Using science to inform risk assessment and regulation (Eric Hallerman, US)

  • Canadian Assessment of Foods and Feeds derived from rDNA animals: teamwork approach (Luc Bourbonniere, Canada)

  • Regulatory frameworks from an emerging economy perspective: Indian regulatory approach to biotechnologies (S.R. Rao, India)

  • Technology and science-directed regulation: Product-based vs. process-based regulation (Harlan Howard, Brinda Dass, and Larisa Rudenko, US)

  • Food animals versus public health applications (Maria Lucia Zaidan Dagli, Brazil)

  • Environmental Risk Assessment for release of animals developed via biotechnology in Canada (Jim Louter, Canada)

         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

        Panel - GE mosquito (Regulatory process, communication with public, lessons learned):

• • Genetically engineered self-limiting Aedes aegypti mosquito (Beech and Gianoto, UK)

  • The Aedes transgenic project (Margareth de Lara Capurro-Guimaraes, Brazil)

  • Malaysian experiences with transgenic mosquito (Letchtummanan Ramatha, Malaysia)

  • Regulatory experience with the GE mosquito release in Panama (Judith Ivette Vargas, Panama)

         Panel - GE salmon (Coordination among regulatory agencies in different countries, challenges in the process, lessons learned):

• •  AquAdvantage salmon (Ron Stottish, US)

  •  Regulatory process of the GE salmon development in Panama (Judith Ivette Vargas, Panama)

  •  GE salmon oversight in Canada (Jim Louter, Canada)

         Concurrent Sessions (breakout dialogs)

• • Advancing opportunities for harmonization

  • Building coalitions within the animal biotechnology sector to affect change 

  • Capacity building needs for emerging markets/less developed regulatory systems

 DAY 3: Wednesday, August 20, 2014

Session 6: Building Trust through Communication and Transparency

         That can’t possibly be true! The science of science communication (Tamar Haspell, US)

         Role of trust in advancing animal biotechnology (Guilharme Trivellato, Brazil)

         GMOs: Addressing concerns and issues through communication (Maha Arujanan, Malaysia)

         Panel:  Approaches to Improve Communication and Improve/Increase Acceptance of Animal Biotechnology

• • Guilharme Trivellato (Brazil)

  • Tamar Haspell (US)

  • Maha Arujanan (Malaysia)

 Session 7: Working Towards Coordination and Harmonization

        Regulatory coordination relevant to GE animals and their products: Domestic and international challenges (Larisa Rudenko, Brinda Dass, and Harlan Howard, US)

          Concurrent Sessions (breakout dialogs)

• • Hypothetical Case Study for Risk Assessment (Yanina Petracca, Argentina)

  • Industry and Policy Makers - Working Together to Set the Stage for Global Harmonization 

Day 4: Thursday, August 21, 2014

Session 8: Science, Regulation and Policy - Working Together to Balance Innovation and Safety

         Innovation in GEOs Governance (Jennifer Kuzma, US)

        Breakout sessions:

        Dialog on guidance gaps, capacity building needs and strategies:

• • Food safety assessment

  • Environmental biosafety assessment

  • Handling of socioeconomic issues

  • Opportunities for harmonization

        Animal health (Gianluco Donelli, Brazil)

        Enough: The fight for a food-secure future (Karla Camargo, Brazil)