USDA, FDA Sign MOU on Animal Biotech Regulations

The USDA and the FDA recently signed a memorandum of understanding to establish a regulatory environment at USDA for agricultural animal biotechnology innovation. The agreement allows USDA to lead animal biotech regulatory framework.

Former Ag Secretary Sonny Perdue stated the effort "clears a path to bring our regulatory framework into the 21st century."

The MOU outlines responsibilities concerning the regulation of certain animals developed using genetic engineering intended for agricultural purposes. The MOU complements USDA's issuance of an Advanced Notice of Proposed Rulemaking on the Movement of Animals Modified or Developed by Genetic Engineering on December 28, 2020. Under this framework, USDA would safeguard animal and human health by providing end-to-end oversight from pre-market reviews through post-market food safety monitoring for certain farm animals modified or developed using genetic engineering intended for human food.

The MOU also allows for the transition of portions of FDA’s pre-existing animal biotechnology regulatory oversight to USDA.

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