Modified Organisms Subject to the Plant Protection Act

The commenter expresses concerns regarding the lack of transparency in federal biotechnology regulations and the expansion of categorical exclusions for genetic insects and vaccines. They also highlight issues with the Endangered Species Act implementation and the potential for biotechnology experiments on public and private lands.

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 Center for Food Safety is submitting supporting materials to reinforce its previous comments regarding the oversight of genetically engineered (GE) crops. The organization advocates for stricter coordination and monitoring by the USDA, EPA, and FDA to ensure public safety and prevent unauthorized releases of GE crops.

Ginkgo Bioworks, a cell and protein engineering company, supports a shift toward a science-based, product-focused regulatory framework for modified organisms. They argue that the current process-based system under 7 CFR Part 340 creates excessive costs and delays, and they recommend deregulating non-food GM crops and aligning the regulation of GE organisms with those of conventionally bred organisms.

The National Grain and Feed Association (NGFA) supports the USDA's role in regulating modified organisms under the Plant Protection Act, emphasizing that regulations must balance plant pest risk with the economic needs of the global agricultural supply chain. They advocate for mandatory pre-market notifications by biotechnology developers to ensure transparency, market access, and the protection of the fungibility of grain and feed commodities.

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.

The Innovative Genomics Institute, a public academic research institute, supports a regulatory framework for modified organisms that is based on specific traits and risks rather than the process of genetic engineering. They argue that because genome editing often results in changes indistinguishable from natural mutations, regulations should focus on evidence-based risk assessments to reduce unnecessary regulatory burdens.

Battelle Memorial Institute, which operates the Pacific Northwest National Laboratory, argues that the current regulatory distinction between conventional and genetically engineered organisms is unnecessary for laboratory-based research. They advocate for a streamlined regulatory framework that either eliminates this distinction for R&D work or provides an exemption for laboratory settings where existing controls are already sufficient.

The Agriculture Biotechnology Alliance (ABA), representing producers and biotechnology developers, supports the USDA's interest in modernizing and deregulating the oversight of modified organisms. They argue for a risk-proportionate, science-based regulatory framework that focuses on the product rather than the process to ensure American farmers remain competitive and have access to innovative biological solutions.