Modified Organisms Subject to the Plant Protection Act

The American Society of Plant Biologists (ASPB), the American Society of Microbiology (ASM), and the Weed Science Society of America (WSSA) oppose shifting the regulatory oversight of genetically engineered (GE) organisms from the Biotechnology Regulatory Services (BRS) to the Plant Protection and Quarantine (PPQ) division. They argue that PPQ lacks the necessary expertise and risk-based regulatory frameworks, which would lead to increased burdens, delays, and potential risks to international trade and public health.

GMO/Toxin Free USA, a public interest nonprofit, opposes shifting the regulation of genetically engineered (GE) organisms from 7 CFR Part 340 to Part 330. They argue that GE organisms present novel risks that require a distinct, strengthened regulatory pathway, and they propose specific amendments to Part 340, including a complete ban on the outdoor release of all GMOs.

The Simplot Company, an agribusiness, supports a shift toward a risk-based, product-focused regulatory framework for modified organisms that evaluates the final product's traits rather than the development process. They argue that current regulations create unnecessary burdens and advocate for streamlined pathways, such as a tiered review process and reliance on prior risk assessments, to improve efficiency for developers.

The Society for Society In Vitro Biology (SIVB) argues that the USDA should discontinue the distinction between conventional and genetically engineered plants because biotechnology does not inherently create new plant pest risks. They advocate for a regulatory framework based on the organism's traits rather than the process used, suggesting that 7 CFR part 330 is sufficient for oversight.

GMO/Toxin Free USA, a public interest nonprofit, opposes shifting the regulation of genetically engineered (GE) organisms from 7 CFR Part 340 to Part 330. They argue that GE organisms pose unique risks that require a distinct, strengthened regulatory pathway, and they specifically advocate for a complete ban on the outdoor release of all GMOs.

Steven H. Strauss, a University Distinguished Professor at Oregon State University, supports a "red flag" regulatory system that focuses on direct, demonstrable plant pest risks rather than the methods used to create modified organisms. He argues for exempting non-coding sequences, native-like modifications, and disarmed Agrobacterium strains from regulation to reduce the burden on innovation and public sector research.

A university researcher argues that the proposed action to reinstate exemptions for the interstate movement of disarmed Agrobacterium strains is necessary to facilitate scientific research and maximize the return on public investment. They contend that the current permitting requirements cause unnecessary delays and do not pose significant environmental risks.

Dr. Christopher Willig, a researcher and entrepreneur, argues that the current regulatory framework for disarmed agrobacterium strains creates unnecessary administrative burdens and costs for researchers and small businesses. He advocates for a more modern, risk-based approach that broadens the criteria for exemptions from plant pest status for genetically engineered microbes.

Dr. Greg S Goralogia, a research associate at Oregon State University, supports the action by requesting specific exemptions for various "disarmed" species of Rhizobiaceae from PPQ/BRS permits. He argues that these microbes are safe, common laboratory tools for gene transfer and that clarifying their regulatory status would facilitate the sharing of materials between academic and industry groups.