Modified Organisms Subject to the Plant Protection Act

The Organic Consumers Association, representing over 23,000 members, opposes the "modernization" of the regulatory process for genetically modified organisms. They argue that the USDA should increase, rather than decrease, oversight and caution regarding biotech products like "plant-incorporated protectants" due to potential health and environmental risks.

The Center for Food Safety (CFS) argues that APHIS should move away from "genetic materiality" as a basis for regulation and instead focus on the specific traits and magnitude of changes produced by genetic engineering. They advocate for a new regulatory regime that covers all GE organisms, requires permits for field trials, and enforces strict gene containment to protect U.S. agriculture and trade.

The Enzyme Technical Association (ETA), a trade association representing enzyme manufacturers and marketers, supports the USDA's efforts to streamline regulations for modified organisms. They specifically advocate for exempting microorganisms used in contained-use fermentation processes from plant pest permitting, arguing that these organisms pose no risk to plant health and that such exemptions would reduce unnecessary regulatory burdens.

The National Association for Plant Breeding (NAPB) supports the USDA's efforts to revise the regulatory framework for modified organisms to be more risk-proportionate and less burdensome. They specifically advocate for broad exemptions for genome-edited plants and streamlined pathways from research to commercialization to ensure that regulatory processes do not disrupt innovation or trade.

The International Food Additives Council (IFAC), a trade association representing manufacturers of food ingredients, supports a risk-based, product-based, and technology-neutral regulatory framework for modified organisms. They argue that the USDA should distinguish between microorganisms used in contained industrial fermentation and those intended for environmental release to ensure regulatory oversight is proportionate to risk and avoids unnecessary duplication with other agencies like the FDA and EPA.

Novonesis, a global biosolutions company, supports the USDA's review of the regulatory framework for modified organisms under the Plant Protection Act. They advocate for a process-agnostic, product-based approach to regulation, the distinction between contained-use and environmental-release microorganisms, and improved interagency coordination to reduce duplicative oversight.

The National Cotton Council, representing the U.S. cotton industry, argues that APHIS should adopt a risk-based, trait-focused regulatory framework rather than one based on the method of development (e.g., genetic engineering). They advocate for moving toward a revised 7 CFR part 330 to ensure that regulations are proportionate to actual plant pest risks, which would reduce burdens on smaller entities and improve international trade competitiveness.

The International Alliance for Phytobiomes Research, a non-profit consortium, argues that there are no inherent material differences in plant pest risk between conventional and genetically engineered microorganisms. They advocate for a science-based regulatory regime that focuses on the characteristics of the final product rather than the process used to create it, utilizing modern genomic tools for risk assessment.

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.

Mr. J. vd Veen opposes the proposed action, arguing that modified nucleic acids (MNA) pose significant risks to global health, food supplies, and marine biotopes. He claims that MNA-based products, particularly for pesticides, could cause irreversible environmental damage and contribute to global extinction.