FDA, USDA face off over GE animal regulation: Will agency dispute lead to science-based rules?

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[O]n the day before President Biden’s inauguration, USDA released a “Memorandum of Understanding” (MOU) in which it was purported that USDA and FDA had agreed to formalize policies wherein the two agencies would take steps to effectuate the transition of regulatory authority over certain GE animals by (1) USDA developing a new regulatory apparatus and (2) FDA ceding “portions” of its current animal biotechnology regulatory oversight to USDA. In what was immediately noted by observers as an odd twist, the MOU was not signed by FDA, but, rather, by Brett Girior, Assistant Secretary for Health in HHS. Then-FDA Commissioner Stephen Hahn, however, immediately made clear that the MOU did not have the backing of FDA.

So, what are the implications of these actions for oversight of ag biotech going forward?

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The USDA MOU was an agreement by political appointees in USDA and HHS. New political appointees in USDA and HHS can just as easily disavow that agreement. Moreover, given the strong objections to the MOU that were voiced by then-Commissioner Hahn, which likely reflect the feelings of FDA staff, the MOU may very well not be supported by the Biden Administration – at least not without further process and buy-in by FDA.

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