HHS Secretary Azar Statement on Agricultural Biotechnology Executive Order

HHS Secretary Alex Azar released the following statement upon President Trump’s signing of an executive order regarding the development of agricultural biotechnology:

“Today’s advances in biotechnology make possible the development of many promising, innovative food products, such as those obtained from genome-edited animals and plants. HHS aims to ensure the safety of these agricultural biotechnology products, as part of FDA’s public health mission, while also increasing regulatory transparency, coordination, and predictability for this emerging area. Enhancing public confidence in the regulatory system while also avoiding unnecessary barriers to biotechnology innovations is a priority for HHS and for the whole Trump Administration.

“Today, President Trump is affirming the importance of agricultural biotechnology innovation by signing an Executive Order to modernize the regulatory frameworks for these products to ensure that they are science-based, timely, efficient, and transparent. We look forward to implementing the Executive Order as part of a regulatory approach to agricultural biotechnology that enables safe innovation to benefit American consumers.”

Background

As part of fulfilling the Executive Order signed today, HHS will continue implementing the FDA’s Plant and Animal Biotechnology Innovation Action Plan released in October 2018. Consistent with the Executive Order, the plan is focused on clarifying FDA’s science-and-risk-based approach for product developers; avoiding unnecessary barriers to future innovation in plant and animal biotechnology; and ensuring the safety of these products to fulfill FDA’s public health mission.

Other ongoing efforts by FDA in this emerging space:

• The FDA has implemented a Veterinary Innovation Program intended to facilitate advancements in development of innovative animal products by providing greater certainty in the regulatory process, which in turn encourages development and research, and supports an efficient and predictable pathway to approval.
• The FDA’s Plant Biotechnology Consultation Program provides developers the opportunity to engage with the FDA to help navigate the regulatory process and, ultimately, bring safe, innovative plant-based food products to market. The program is part of overall efforts by FDA to enhance engagements with developers in this emerging area of innovation at home and abroad.