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