The Future of Microbial Biotechnology: From Research to Regulation

February 02, 2022 - February 03, 2022

Organized in collaboration with

  • Innovative Genomics Institute (IGI)
  • U.S. Department of Agriculture (USDA)

Location

Online

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.

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)

11:20am – Panel – GEMs in Food and Agriculture

Kate Krueger (Helikon Consulting), Bruce Friedrich (Good Food Institute)

Moderator: Jenny Splitter (Freelance journalist)

11:50am – Regulatory Overview – FDA – Food and Feed Safety

Shayla West-Barnette (CFSAN) and Diego Paiva (CVM)

12:35pm – Regulatory Overview – USDA – Food and Agriculture

Martha Malapi-Wight (APHIS-BRS) and John Hicks (FSIS)

1:20pm – Break

1:50pm – Panel – GEMs in the Environment and Biomanufacturing

Kent Smith (bioMASON), Spencer Diamond (IGI), Jay Fitzgerald (DOE), TBD (Fish and Wildlife Services)

Moderator: Julie Shapiro (Keystone Policy Center)

2:20pm – Regulatory Overview – EPA – Pesticides and Industrial Uses

Kara Welch (OPP) and Gwen McClung (OPPT)

3:05pm – Panel – Scientific Advances and the Future of GEMs

Megan Palmer (iGEM), 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

DAY 2 – Thursday 3 February

11:00am – Welcome  Summary of Day 1 and Intro to Day 2

Anastasia Bodnar (USDA-OCE)

11:05am – Regulatory Overview – USDA-AMS – GEMs in the Bioengineered Food Disclosure Standard

Alex Fischer (USDA-AMS)

11:20am – Trade and Markets Overview – FAS – GEMs in International Trade

Jen Rowland (USDA-FAS)

11:35am – 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 – Case Studies and Corresponding Regulatory Approaches 

Kellye Eversole (Phytobiomes Alliance)

3:30pm – Closing

Melinda Kliegman (IGI)