U.S. Agencies Unveil New Tool to Aid Biotechnology Developers in Navigating Regulations

On October 2, 2024, the U.S. Department of Agriculture (USDA), Environmental Protection Agency (EPA), and Food and Drug Administration (FDA) jointly launched a web-based tool designed to guide companies in developing microbial biotechnology products. The newly released tool, hosted on the Unified Website for Biotechnology Regulation, aims to help developers, especially those new to the industry, navigate the complex regulatory landscape.

Key Updates

The tool serves as a user-friendly starting point for researchers working on genetically modified microorganisms, including plants, animals, and microbes. Through a series of interactive prompts, the tool offers regulatory guidance based on the product’s characteristics and intended use. It is a significant step toward achieving the goals outlined in Executive Order 14081, which emphasizes transparency, efficiency, and public trust in the biotechnology regulatory framework.

Tested in August 2024 with input from a diverse range of biotechnology stakeholders, the tool has been refined to cater to various user needs. It features a feedback mechanism that allows ongoing improvements based on direct input from the biotechnology community.

Beyond this tool, the agencies are aligning USDA and EPA data requirements to streamline the review process and reduce duplicative assessments. Additionally, the USDA is exploring simplified pathways for the commercialization of genetically engineered microbes.

Source: EPA

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