President Biden Launches National Biotechnology and Biomanufacturing Initiative to Improve Regulatory Clarity

Strategic Insights -

President Biden's September 12, 2022, Executive Order (EO) aims to enhance the regulatory processes for biotechnology products, promoting innovative solutions in health, climate change, energy, and national security. The "National Biotechnology and Biomanufacturing Initiative" calls on the EPA, USDA, and FDA to identify areas of ambiguity and gaps in the January 2017 Coordinated Framework for the Regulation of Biotechnology and EO 13874.

Key Takeaways:

  • The EO charges the EPA, USDA, and FDA with providing plain-language information to the public on regulatory roles, responsibilities, and processes related to biotechnology products.
  • The agencies are tasked with identifying regulations and guidance to update, streamline, or clarify, and providing annual updates to identify gaps in statutory authority.
  • The Unified Website for Biotechnology will be updated to allow developers to inquire about products and receive a single, coordinated response regarding Federal regulatory review.
  • USDA is directed to assess how to use biotechnology and biomanufacturing for food and agriculture innovation, focusing on sustainability, food quality, agricultural yields, and pest and disease protection.
  • The initiative aims to promote innovative biotechnology and biomanufacturing solutions for health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security.

Statistics:

  • The January 2017 Update to the Coordinated Framework for the Regulation of Biotechnology and EO 13874 is the basis for the regulatory review.
  • The Unified Website for Biotechnology will be updated to provide a single, coordinated response for Federal regulatory review.
  • 5 areas of focus for USDA's assessment of biotechnology and biomanufacturing for food and agriculture innovation: sustainability, food quality, agricultural yields, pest and disease protection, and alternative food sources.
  • No specific timeline is provided for this initiative, with annual updates expected from the EPA, USDA, and FDA.

Sources:

  • [1] President Biden's September 12, 2022, Executive Order (EO)
  • [2] January 2017 Update to the Coordinated Framework for the Regulation of Biotechnology and EO 13874
  • [3] Unified Website for Biotechnology