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Animal Biotech Authority Becoming Point of Contention Between Agencies

Vipin Saini
Vipin Saini
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Biotechnology

A Memorandum of Understanding (MOU) pertaining to animal biotech authority is creating some confusion. Assistant Secretary for Health and Head of the Public Health Service at the U.S. Department of Health and Human Services (HHS) Admiral Brett Giroir, M.D. signed the MOU along with outgoing Secretary of Agriculture Sonny Perdue. The document lays out a framework for certain regulatory authorities of agricultural animal biotechnology to move to the U.S. Department of Agriculture (USDA). 

This Memorandum of Understanding clears a path to bring our regulatory framework into the 21st century, putting American producers on a level playing field with their competitors around the world. In the past, regulations stifled innovation, causing American businesses to play catch-up and cede market share. 

The MOU is in line with the recent Advanced Notice of Proposed Rulemaking (ANPR) issued by USDA related to genetically modified animals. Altogether, the actions will move certain animal biotech authority from the U.S. Food and Drug Administration (FDA) to USDA. The effort has been largely supported by agricultural groups.  

Unfortunately, the FDA Commissioner Stephen Hahn is not in agreement with this development. In a statement issued he said “FDA does not support the Memorandum of Understanding that [HHS] signed with [USDA] announced today. FDA has no intention of abdicating our public health mandate. FDA believes it is essential that any potential changes to the current regulatory framework be informed by public feedback and capture the agencies’ distinct missions with respect to animal and human health.” 

Provisions of the MOU support the ANPR in creating a regulatory framework to apply to certain animals such as cattle, poultry, swine, and sheep.  

However, the objection from FDA creates uncertainty about how the process will move forward, as the FDA is a division of HHS. The change of administration will bring new leadership to USDA and HHS. Industry stakeholders are monitoring the situation as the new leadership positions move in. 

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