Modified Organisms Subject to the Plant Protection Act

The Biological Products Industry Alliance (BPIA), representing over 180 member companies, supports the USDA's request for information to modernize the regulatory framework for modified organisms. They argue for a science-based, risk-proportionate pathway that provides clear commercialization endpoints and reduces duplicative oversight for microbial products.

Bayer Crop Science supports the USDA's efforts to evaluate risk-based deregulation of genetically engineered (GE) organisms and advocates for streamlining existing regulations. They specifically recommend updating the definition of a "regulated article" to focus on actual plant pests rather than development methods, while maintaining the current 7 CFR Part 340 framework to ensure regulatory predictability.

The Agriculture and Food Systems Institute (AFSI) supports the USDA's initiative to address the regulatory framework for modified organisms, specifically advocating for a risk-proportionate, product-based approach. They argue that current regulations (7 CFR Part 340) are ill-suited for microorganisms and recommend adopting a tiered structure similar to the SECURE rule to reduce burdens on small entities and researchers.

The American Soybean Association (ASA) opposes moving the regulation of genetically engineered (GE) organisms from Section 340 to Section 330 of the Plant Protection Act. They argue that Section 330's broader definitions and "biological potential" standard would create regulatory uncertainty, increase compliance burdens, and harm the competitiveness of U.S. soybean exports.

The National Corn Growers Association (NCGA) supports the development of a modern, risk-proportionate regulatory framework for modified organisms that prioritizes science-based risk assessment over the biotechnology method used. They advocate for streamlined review processes, international harmonization to protect export markets, and reduced regulatory burdens for smaller developers to ensure continued access to improved seed genetics.

Switch Bioworks, an American biotechnology start-up, supports the development of a modernized, science-based regulatory framework for engineered microbes. They argue for a risk-focused approach that evaluates organisms relative to their wild-type counterparts, advocates for "organism-trait-mechanism of action" permitting, and seeks to reduce regulatory burdens and duplicative reviews with other agencies like the EPA.

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 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.

The Breakthrough Institute supports streamlining the regulation of agricultural biotechnology by moving toward a risk-proportionate system that focuses on the traits of a product rather than the technology used to create it. They specifically advocate for withdrawing 7 CFR Part 340 and modifying 7 CFR Part 330 to align with scientific consensus that genetic engineering does not inherently create unique plant pest risks.

Norfolk Healthy Produce, a commercial developer of transgenic crops, argues that APHIS should adopt a risk-proportionate regulatory framework that eliminates trigger-based regulation for modified organisms. They advocate for regulating only those organisms that meet the definition of a plant pest, emphasizing that the mode of development (genetic engineering) does not inherently create distinct plant pest risks.