View EO 12866 Meeting 0910-ZB10

Title: Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach; Guidance for Industry ("GFI 187A")

Agency/Subagency: 0910-HHS/FDA

Stage of Rulemaking: Notice Stage

Meeting Date/Time: 09/28/2023 01:00 PM

Requestor: Center for Food Safety and GE Animal Coalition Requestor's Name: Jaydee Hanson

Documents:

List of Documents
Comprehensive analysis and accurate quantification of unintended large gene modifications induced by CRISPR-Cas9 gene editing
Federal Court Rules that FDA must reasses environmental and endangered species risks from GE Salmon
Final Group letter to Secretary Becerra on GE animals.
aavs_report_ge-anmial-welfare
FAO-WHO Safety assessment of foods from GM animals 2003
CRISPRthripis: The risk of CRISPR/Cas9-induced chromothripsis in gene therapy 2022
Chromothripsis as an on-target consequence of CRISPR-Cas9 genome editing 2021
FAO/WHO Expert Consultation on the Safety Assessment of Foods Derived from Recombinant-DNA Animals 2007

Attendees:

List of Attendees		Participation
•	Julie Wise - OMB	Teleconference
•	Daniel Jedzinak - FDA	Teleconference
•	Eric Flamm - FDA	Teleconference
•	Joanne Davenport - OMB	Teleconference
•	Jane Wargo - HHS	Teleconference
•	Diane Heinz - FDA	Teleconference
•	Laura Epstein - FDA	Teleconference
•	Nicole Pepperi - FDA	Teleconference
•	William Flynn - FDA	Teleconference
•	Tristan Colonius - FDA	Teleconference
•	Malaika Elias - Friends of the Earth	Teleconference
•	Crystal Schaeffer - American Association against Vivisection	Teleconference
•	Michael Hansen - Consumers Union	Teleconference
•	Amy Van Saun - Center for Food Safety	Teleconference
•	Antonio Tovar - National Family Farm Coalition	Teleconference
•	Jaydee Hanson - Center for Food Safety	Teleconference
•	Dana Perls - Friends of the Earth	Teleconference