FULL AGENDA

Day 1 – Monday, September 12

Opening Remarks & Welcome   (8:30am – 8:45am)

Maria Dagli – introduce Paulo Barroso

Paulo Barroso (EMBRAPA, President of CTNBio, Brazil)                                    

Session 1 (8:45am – 12:35pm) Introduction to Animal breeding

Moderator: Luiz Sergio Camargo

Animal breeding systems and biotechnologies

• • From Galton to Machine Learning: a brief account of quantitative methods in animal genetic improvement (Dan Gianola, University of Wisconsin, USA)

  • Application of Genomics on Brazilian Dairy Farms (Marcos Vinicius G. B Silva, EMPRAPA, Brazil)

• Impact of animal reproductive biotechnologies (Pietro Sampaio Baruselli, USP, Brazil)

• Breed association (Ana Granados, European Forum of Farm Animal Breeders)

• Impact of genomics for Sustainable Intensification of Beef Production in the Tropics (Fernando Baldi, UNESP, Brazil)

Q&A Panel 1: Dairy/ beef - superior male/semen distribution

• • Genomic selection and trait discovery (Mike Paustian, Iowa Pork Producers past president, USA)

• Breeding challenges faced by small holders and need for access to improved genetics (Sharon Andeyo Tsigadi, Farmers Choice, Africa)

• Setting the standard for Sustainable Animal Breeding - viewed by Hendrix Genetics (Gosse Veninga, Hendrix)

• Aquaculture (Alan Tinch, Center for Aquaculture Technologies, USA) Q&A Panel 2: Aquaculture/small rum/poultry/ swine/small holders – Ana Granados; Mike Paustian; Sharon Andeyo Tsigadi; Gosse Veninga; Alan Tinch

Q&A Panel 2: Aquaculture/small rum/poultry/ swine/small holders – Ana Granados; Mike Paustian; Sharon Andeyo Tsigadi; Gosse Veninga; Alan Tinch   

Session 2 (1:30pm – 5:15pm) Animal genetic biotechnologies in the pipeline and future possibilities

Moderator: Alison Van Eenennaam

• • Livestock Biotechnology – why and how? (Simon Lillico, UK)

Genome Editing, focusing on:

• Animal health (Christine Tait-Burkard, Roslin Institute, UK)

• Nutritional Enhancement and Animal Biotechnology: Gene adding and gene editing (Mark Tizard, CSIRO, Australia)

• Animal welfare – “Application of genome engineering to facilitate point of lay sex-sorting in the poultry industry” (Caitlin Cooper, Hendrix)

• Breeding climate smart cattle for sub-tropical and tropical zones (Tad Sonstegard, Acceligen)

• Protecting, preserving and restoring African poultry biodiversity (Christian Tiambo, ILRI, Africa)

• Non-profit development - genome editing solutions to address animal agriculture issues (Brantley Browning, BMGF, USA)

• Combining genomic selection and genome editing to drive genetic improvement (Elena Rice, Genus)

• Genome editing for service (Jon Oatley, APYSbio)

• Livestock Tick Friendly Technology (Hellen Abreu, Oxitec, UK/LATAM)

• Reproductively confined aquaculture (Anna Wargelius, Institute of Marine Research, Norway)

• Biotechnology Development for use in Ecosystem Conservation- Podcast Version ( (Royden Saah, Island Conservation)

PANEL: How regulations shape decisions as to what to edit, what traits to pursue, etc. – developer perspectives – (not recorded or live streamed)

Moderator: Mark Tizard

• • Elena Rice (large breeding company, Genus), Debbie Plouffe (small developer/company, CAT), Brantley Browning (NGO/non-profit, BMGF), Jon Oatley (small developer and dean of research role), Christian Tiambo (researcher in developing country), Mike Paustian (Iowa Pork Producers past president)

Day 2 - Tuesday, September 13

Session 2 (continued) (8:30am – 8:50am) Animal biotechnologies in the pipeline and future possibilities

•   Agricultural applications in China to enhance sustainability (Kui Li, China)

Session 3 (8:50am – 10:10am) Biosafety and conventionally-bred animals

Moderator: Maria Dagli, CTNBio, Brazil

• • Biosafety on the Farm (Viviani Gomes, Brazil)

• Food Safety at Slaughter (Christyn Stumps, FSIS) – what measures are in place for protecting human and animal health for conventional products? – USDA/FSIS

• How do agencies/ministries with shared responsibility work together? (Maria Dagli, UFSP, Brazil)

• Protecting the genetics in the breeding population, using genomics (Sofía Ortega, University of Wisconsin, USA)                    

Session 4 (10:20am – 12:40pm) Concepts in biotech regulatory approaches

Moderator: Mahaletchumy Arujanan, ISAAA BioTrust

• • Codex Alimentarius (Andres Maggi, Argentina)

• Cartagena Protocol (Pedro Rocha, IICA)

• Familiarity – what can we learn from what we already know? Drawing from: experience with biotech plants, “conventional” food safety, animal breeding/sequencing data (Jose Fernando, Brazil)

PANEL: Off Target changes, conventional mutation and regulatory approaches for genome editing [regulator, academic, industry perspectives] (~11:30am – 12:40pm)

Moderator: Anastasia Bodnar

• • Luiz Sergio Camargo (Brazil), Florencia Goberna (Argentina), Simon Lillico (UK), Tad Sonstegard (USA)

Session 5 (1:30pm – 2:30pm) Risk Assessment

Moderator: Mariana Murrone, Argentina

• • Problem Formulation: Identification, evaluation, mitigation and control of risks (Andrew Roberts, AFSI, USA)

• Food safety and nutritional considerations (Marilia Nutti, EMBRAPA, Brazil)

• Environmental assessment - unique issues and potential risks for biotech animals (Eric Hallerman, VaTech, USA)  

Session 6 (2:30pm – 6:30pm) Putting Animal Biotechnology in Context (including Socioeconomic Considerations and Public Outreach/Communication)

Moderator: Caitlin Cooper 

• Animal Welfare - Video Version (Adroaldo Zanella, University of São Paulo, Brazil)

• Ethical issues: Genome editing of agricultural animals (Sarah Chan, University of Edinburgh, UK)

• Cost of disease burden, from different perspectives (Dustin Pendell, USA)

• Economic impact of regulatory approach (Gabriela Garrappa, Argentina)

• Trade perspectives and obligations (Andrew Devine, USTR, USA)

• Communicating with the general public about GMOs and genome edited organisms (Alison Van Eenennaam, University of California – Davis, USA)

• Government communication strategies (Anastasia Bodnar, USDA)

PANEL: Communication and public engagement (in-person only)

Moderator: Margaret Karembu

• • Alison Van Eenennaam, Anastasia Bodnar, Mahaletchumy Arujanan

Day 3 - Wednesday, September 14

Session 7 (8:30am – 12:55pm) Panel - Regulatory approaches (and GMO triggers) in different countries

Moderator: Rhodora (Olah) Romero-Aldemita, ISAAA Inc.

• • General overview from questionnaire - general global trends (Dan Kovich, US)

Panel – short talks from panelists first to set stage/give background

• Argentina - First country to publish GnEd approach; first non-GMO decision (Mariana Murrone, Florencia Goberna, Argentina) 

  • Argentina: regulatory framework for GM Animals, Mariana Murrone, Argentina

  • Argentina Regulatory - New Breeding Techniques (NBT), Florencia Goberna, Argentina

• Brazil - Non-GMO decisions for GnEd animals (Luiz Sergio Camargo, Brazil)

• Australia (OGTR) - Public comment process, GT Scheme (Heidi Mitchell)

• Kenya - Developing new animal biotech regulations and GnEd approach (Anne Muia, NBA, Kenya)

·         General discussion                          

Country updates (~10:00am – 12:55pm):

• Colombia (Yenny Catherine Pinilla Lopez)

• Ethiopia (Hailu Dadi Melka)

• Philippines (Claro Mingala)

• United States (Laura Epstein)

• Paraguay (Sandra Alvarez)

• United Kingdoms (Oana Georgescu and Caroline Povey)

[Note: Remaining sessions were not live streamed]

Session 8 (1:55pm – 2:55pm) Panel - Regulator-Developer dialog

Moderator: Simon Lillico

Developers:                      

• AquaBounty (Chantal March, AquAdvantage Salmon: The Regulatory Journey)

• Acceligen (Ana Maria Perez O’Brien)

•  Oxitec (Hellen Marilia Couto de Abreu, GM Spodoptera frugiperda Regulatory Approval Pathway in Brazil)

• Genus (Clint Nesbitt)

Regulators:

• • Argentina (Mariana Murrone, Florencia Goberna), Brazil (Maria Dagli), USA (Heather Lombardi)

Session B1 (3:00pm – 4:00pm) Break out exercise on regulatory triggers – Round tables in room (case studies)

Round table activities – Case studies

• Null-segregant (Mark Tizard)

• GnEd deletion (Maria Dagli)

Session B2 (4:10pm – 6:10pm) Concurrent sessions

• B2a. for Government Officials: Regional breakout groups (Africa, Latin America, Asia, rest of world) – identify gaps/needs/priorities – plan forward

Discussion Leaders and Scribes (USDA/FAS):

• • Africa – Margaret Karembu (lead)/ Allan Kimitei (scribe)

  • Latin America – Pedro Rocha (lead)/ Camila Aquino and Karla Tay (scribes) – may need 2 sub-groups

• Asia – Olah (lead)/ Tanvir Hossain (scribe)

• Rest of world – Heidi Mitchell (lead)/ Marta Guerrero (scribe)

Regulators and Government Officials: Regional animal biotechnology issues and next steps

• • Potential topics of discussion and debate:

• Special features of animal biotechnology, which could benefit region

• Capacity and capability of countries in your region to develop GMOs and their products

• Challenges and prospects for developing biotech animals in region

• Developing training opportunities for researchers/regulators

• Identifying capacity and challenges of developing regulatory frameworks

• Creating regional public awareness and best communicate about biotechnology

• B2b. for industry:

  • Moderator: Ana Granados / Scribe: Eric Hallerman

  • Developers and Animal Industry: Getting biotech solutions to farmers; publicly-funded research and public-private partnerships

POSTER RECEPTION for regulators and government officials to present (set up in break/reception area)      

Day 4 - Thursday, September 15  

Session 9 (8:30am – 10:20am) Panel - Regulatory experiences with genome-edited animals

Moderator: Pedro Rocha

• • GnEd Cattle in Brazil (CTNBio – Luiz Sergio and Rubens Nascimento)/Argentina 

  • GnEd Cattle in Argentina - Ana Maria Perez O’Brien, Acceligen

  • Panel - Access and Benefits Sharing: Challenges of researchers and developers with movement of tissues between countries and coordination of conventional and biotech regulations

    • Luiz Sergio De Almeida Camargo (EMBRAPA), Ana Maria Perez O’Brien (Acceligen), Mark Tizard (CSIRO), Chantal March (AquaBounty), Christian Tiambo (ILRI), Popoola Mustapha (Nigeria)

Session 10 (10:30am – 11:30pm) Presentations/Panel discussion – How countries make agency decisions and is it possible to harmonize?

Moderator: Hellen Mbaya

Examples of regulatory cooperation (plant or animal)

• Working together to facilitate import and export (Melody Maxwell, APHIS/IS, Brazil)

• Latin American experience of regulatory cooperation (Pedro Rocha, IICA)

• Harmonization with Brazil and Argentina (Andres Maggi, SENASA, Argentina)                                     

Session 11 (11:30am – 12:35pm) Building trust in Animal Biotechnology

Moderator: Rhodora (Olah) Romero-Aldemita, ISAAA, Inc.  

• Building trust with the public, Mahaletchumy Arujanan, ISAAA

• Industry view (Chantal March, AquaBounty, USA) – “What a great new product! Will anyone buy it??? – A Fishy Tale”

• Panel above plus: Alison Van Eenennaam (UC-Davis), Clint Nesbitt (Genus), Andrew Bailey (NPPC)

Session B3 (1:50pm – 3:20pm) Concurrent breakout discussions on regulatory cooperation and building trust

·         Framing talk – Types of cooperation? How do we keep the conversation going?

• B3a: Regulators/govt officials: - Break outs/small groups to discuss regulatory cooperation 

Overall coordinator: Margaret Karembu with support Hellen Mbaya

• • Discussion Leads and Scribes:

  • Topic 1 Opportunities for cooperation and harmonization/alignment and sharing of risk assessments across countries (reduce duplication) and data transportability (mechanism)

  • Leader/scribe – Pedro Rocha; USA/FAS/LES

  • Topic 2 How to get publicly funded to market – movement of tissues

  • Leader/scribe – Argentina (Gabriela Garrappa); Luiz Sergio

  • Topic 3 Conventional/biosafety challenges and how this applies to biotech products for trust and cooperation

    • Leader/scribe – Dan Kovich (USDA); USA/FAS/LES

  • Topic 4 Maintaining public confidence and trust without inhibiting innovation

  • Leader/scribe – Anastasia Bodnar (USDA); Rhodora (Olah) Romero-Aldemita

  • B3b: Researcher/developers/industry: Addressing barriers to public trust

Session 12 (3:30pm – 5:55pm) Looking to the future      

Moderator: Eric Hallerman

• • Report back to general session B3 and B2 

• Discussion - How do we keep the conversation going?

Day 5 - Friday, September 16

Session B4 (8:30am – 1:00pm) Hands-on Exercise - (includes break; regulators/government officials only)             

• • For Regulators: Problem formulation exercise (Andrew Roberts – AFSI, USA)

Hosted by:  U.S. Department of Agriculture, Virginia Polytechnic Institute and State University, Inter-American Institute for Cooperation on Agriculture (IICA), International Service for the Acquisition of Agri-biotech Applications (ISAAA), University of São Paulo, Agriculture & Food Systems Institute (AFSI)