Comments to Docket No. FDA-2008-D-0394 regarding the draft guidance for industry addressing regulation of intentionally altered genomic DNA in animals.
CSPI supports science- and risk-based oversight by the Food and Drug Administration (FDA) of new products entering the food supply to ensure they are safe to humans and the environment. However, draft GFI #187 captures every single genomic altered animal and imposes the same regulatory requirements. Instead, FDA should establish a proportionate risk-based regulatory system where the degree of oversight for different genomic altered animals is based on the potential risks they pose.