Outline
In the last decade, significant advancements have been made in research, development, and regulatory policy for genetically engineered microorganisms (GEMs).
In this virtual workshop, you will hear from public and private sector developers about cutting-edge research, and U.S. regulatory officials will discuss how they review GEMs.
This event is jointly organized by the Innovative Genomics Institute (IGI), U.S. Department of Agriculture (USDA), and the Phytobiomes Alliance.
Presenters
Program
All times are in US Eastern Time (UTC/GMT -5 hours)
DAY 1 – Wednesday 2 February
11:00am – Welcome – What Are GEMs and Why Are They Important? Anastasia Bodnar (USDA-OCE)
11:05am – Regulatory Overview – USDA – What is the Coordinated Framework? Sally McCammon (USDA-APHIS) – McCammon Slides (PDF)
11:20am – Panel – GEMs in Food and Agriculture. Kate Krueger (Helikon Consulting), Bruce Friedrich (Good Food Institute), Bjorn Traag (Andes Ag), and Guillaume Barbier (JoynBio). Moderator: Jenny Splitter (Independent journalist)
11:50am – Regulatory Overview – FDA – Food and Feed Safety. Shayla West-Barnette (CFSAN) and Diego Paiva (CVM) – West-Barnette Slides (PDF), Paiva Slides (PDF)
12:35am – Regulatory Overview – USDA – Food and Agriculture. Martha Malapi-Wight (APHIS-BRS) and John Hicks (FSIS) – Malapi-Wight Slides (PDF), Hicks Slides (PDF)
1:20pm – Break
1:50pm – Panel – GEMs in the Environment and Biomanufacturing. Kent Smith (bioMASON), Spencer Diamond (IGI), and Jay Fitzgerald (DOE). Moderator: Julie Shapiro (Keystone Policy Center)
2:20pm – Regulatory Overview – EPA – Pesticides and Industrial Uses. Kara Welch (OPP) and Gwen McClung (OPPT) – Welch Slides (PDF), McClung Slides (PDF)
3:05pm – Panel – Scientific Advances and the Future of GEMs. Megan Palmer (Stanford University), David Savage (IGI), Rodolphe Barrangou (NC State), and Anne Cheever (DARPA). Moderator: Andrea Hodgson (Schmidt Futures)
3:45pm – Q&A | Discussion. Melinda Kliegman (IGI)
4:15pm – Closing. Melinda Kliegman (IGI)
DAY 2 – Thursday 3 February
11:00am – Welcome – Summary of Day 1 and Intro to Day 2. Melinda Kliegman (IGI)
11:05am – Regulatory Overview – USDA-AMS – GEMs in the Bioengineered Food Disclosure Standard. Alex Fischer (USDA-AMS) – Fischer Slides (PDF)
11:20am – Trade and Markets Overview – FAS – GEMs in International Trade. Jen Rowland (USDA-FAS) – Rowland Slides (PDF)
11:35 am – Panel – Societal Engagement and Public Education. Jennifer Kuzma (NC State), Charles Denby (Berkeley Yeast), and Charlie Arnot (CFI). Moderator: Brittany Anderton (Science Communication Lab)
12:05pm – Q&A | Discussion. Melinda Kliegman (IGI)
12:30pm – Break
1:00pm – Review and discussion of Case Study #1 – Biofertilizer: Genetically Engineered Azospirillum brasilense for extended ammonia production. Moderator: Kellye Eversole (Phytobiomes Alliance)
1:05pm – Overview of the Technology – Tim Schnabel (Stanford University) and Myles Herbert (Indigo Ag) – Schnabel & Herbert Slides (PDF)
1:30pm – APHIS Response – Subray Hedge (BRS) – Hedge Slides (PDF)
1:50pm – EPA Response – Gwen McClung (OPPT)
2:10pm – Q&A | Discussion
2:25pm – Break
2:35pm – Review and discussion of Case Study #2 – Biopesticide (hypothetical): Genetically Engineered Trichoderma harzianum . Moderator: Kellye Eversole (Phytobiomes Alliance)
2:40pm – Overview of the Technology – Carly Odynsky (Joyn Bio) – Odynsky Slides (PDF)
3:05pm – EPA Response – Kara Welch (Office of Pesticide Programs)
3:25pm – APHIS Response – Subray Hedge (BRS)
3:45pm – Q&A | Discussion
4:00pm – Case Studies Wrap-Up. Kellye Eversole (Phytobiomes Alliance)
4:05pm – Workshop Closing – Anastasia Bodnar (USDA-OCE)
Recording
The recorded sessions are nested into a single YouTube playlist, embedded below. If you’d like to see the list of videos and select the one you’d like to watch, check out the playlist on YouTube here.