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Federal Coordinated Framework for Regulating Biotechnology

05/13/2024

 

Based on legislation in 1986 and an updated 2017 Executive Order #14081, three federal agencies have established a memorandum of understanding relating to biotechnology.  The Executive Order entitled “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe and Secure American Bioeconomy,” has brought together the resources of the U.S. Environmental Protection Agency, the U.S. Food and Drug Administration and the U.S. Department of Agriculture.  The agencies are tasked with establishing a coordinated framework to address economic advancement through biotechnology.  This will include modified plants, animals and microorganisms and the development of pharmaceuticals and biologics.

 

The agencies intend to “clarify and streamline regulatory oversight for GM plants, animals and microorganisms.  The agencies will also share information and enhance inter-agency communication.

 

Given the history of delays in reviewing and approving GM modification for plants and animals, coordination and prompt evaluation of applications is obviously required.  Unfortunately, the Executive Order attempts to generate progress through engendering cooperation among three different agencies with entrenched and diverse cultures. This will be analogous to herding cats.  The FDA has no business in becoming involved with GM animals for food production although there is justification to regulate GM modification to produce biopharmaceuticals in milk and eggs. Neither the EPA nor FDA is competent to be an arbiter of aspects of food production.

 

It is generally conceded that other than the FSIS, the USDA with its farmer-oriented bias, cannot be relied on to protect public health by regulating food production.  Attempting to establish cooperation and synergy among three essentially competitive agencies each defending their respective turf does not auger well for the intent of Executive Order #14081. An independent food safety and nutrition agency is required.