4th International Workshop on Regulatory Approaches for Agricultural Applications of Animal Biotechnologies
September 12-16, 2022
São Paulo, Brazil
Organizing Committee: Diane Wray-Cahen (U.S. Department of Agriculture), Eric Hallerman (Virginia Tech, USA), Maria Lucia Zaidan Dagli (University of Sao Paulo, and CTNBio, Brazil), Pedro Rocha (Inter-American Institute for Cooperation on Agriculture, Costa Rica), Anne Ndanu Muia (Kenyatta University and Biosafety Kenya, Kenya), Margaret Karembu (ISAAA AfriCenter, Kenya), Olah Aldemita (ISAAA SEAsiaCenter, Philippines), Dan Kovich (U.S. Department of Agriculture – Foreign Agriculture Service), Mark Tizard (CSIRO, Australia), Heather Lombardi (HHS – U.S. Food and Drug Administration), Kayla Knilans (U.S. Department of Agriculture – Animal and Plant Health Inspection Service), Mark Walton (AquaBounty, USA), Luis Sergio Camargo (EMBRAPA, Brazil), Mariana Murrone (Ministry of Agriculture, Argentina), Justin Bredlau (U.S. Department of Agriculture), Bruce Whitelaw (Roslin Institute, UK)
Participants:
- 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
- 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 (Royden Saah, Island Conservation)
- Agricultural applications in China to enhance sustainability (Kui Li, China)
- 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)
- 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)
- 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]
- Moderator: Anastasia Bodnar
- Luiz Sergio Camargo (Brazil), Florencia Goberna (Argentina), Simon Lillico (UK), Tad Sonstegard (USA)
- 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)
- Moderator: Caitlin Cooper
- Animal Welfare (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
- 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
- Argentina - First country to publish GnEd approach; first non-GMO decision (Mariana Murrone, Florencia Goberna, Argentina)
- Country updates:
- 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)
- Nigeria (Rufus Ebegba)
- Moderator: Simon Lillico
- Developers:
- AquaBounty (AquAdvantage Salmon: The Regulatory Journey) (Chantal March)
- Acceligen (Friendly Fall Armyworm) (Ana Maria Perez O’Brien)
- Oxitec (GM Spodoptera frugiperda Regulatory Approval Pathway in Brazil) (Hellen Marilia Couto de Abreu)
- Genus (PRRSV Pigs) (Clint Nesbitt)
- Regulators:
- Argentina (Mariana Murrone, Florencia Goberna), Brazil (Maria Dagli), USA (Heather Lombardi)
- Session B1 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)
- Round table activities – Case studies
- Session B2 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
- Moderator: Pedro Rocha
- GnEd Cattle in Brazil (CTNBio – Luiz Sergio Camargo 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)
- 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)
- Moderator: Rhodora (Olah) Romero-Aldemita, ISAAA, Inc.
- Building trust with the public, Mahaletchumy Arujanan, ISAAA
- Industry view: “What a great new product! Will anyone buy it? – A Fishy Tale” (Chantal March, AquaBounty, USA)
- Panel above plus: Alison Van Eenennaam (UC-Davis), Clint Nesbitt (Genus), Andrew Bailey (NPPC)
- Session B3: 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
- Moderator: Eric Hallerman
- Report back to general session B3 and B2
- Discussion - How do we keep the conversation going?
- Session B4: 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)